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Job Description
The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager or CRD, the person ensures compliance of study conduct with ICH/GCP and country regulations, Company policies and procedures, quality standards and adverse event reporting requirements internally and externally. Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites. Actively develops and expands the territory for clinical research, finding and developing new sites. Participates in internal meetings and workstreams as SME for monitoring processes and systems.
Responsibilities include, but are not limited to:
•Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
•Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
•Gains an in-depth understanding of the study protocol and related procedures
.•Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
•Participates & provides inputs on site selection and validation activities.
•Performs remote and on-site monitoring & oversight activities using various tools to ensure:
oData generated at site are complete, accurate and unbiased.
oSubjects’ right, safety and well-being are protected.
•Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
•Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
•Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
•Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM, TA Head and CRD as needed.
•Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites.
•Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
•Contributes strongly to CRA team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.
•Supports and/or leads audit/inspection activities as needed.
•Following the country strategy defined by CRD and CRA manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities.
•Mentors / buddies junior CRAs on process/study requirements and performs co-monitoring visits where appropriate.
CORE Competency Expectations:
•Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.
•Excellent understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines. •Excellent understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
•Demonstrated ability to mentor/lead.
•Hands on knowledge of Good Documentation Practices.
•Proven Skills in Site Management including independent management of site performance and patient recruitment.
•Demonstrated high level of monitoring skill with independent professional judgment.
•Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.
•Ability to understand and analyze data/metrics and act appropriately, also in a virtual environment.
•Experience with conducting site motivational visit designed to boost site enrollment.
•Capable of managing complex issues, works in a solution-oriented manner.
•Performs root cause analysis and implements preventative and corrective action.
•Capable of mentoring junior CRAs on process/study requirements and is able to perform co-monitoring visits where appropriate.
Behavioural Competency Expectations:
•Effective time management, organizational and interpersonal skills, conflict management, problem solving skills.
•Able to work highly independently across multiple protocols, sites and therapy areas.
•High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment.
•Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
•Demonstrates commitment to Customer focus.
•Works with high quality and compliance mind-set.
•Positive mindset, growth mindset, capable of working independently and being self-driven
•Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices.
Experience Requirements:
Required:•Min. 4 years of direct site management (monitoring) experience in a bio/pharma/CRO.
Travel
• Ability to travel domestically and internationally approximately 65%-75% of working time. Expected travelling ~2-3 days/week.
• Current driver’s license preferred (Must have in certain countries).
.
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
HybridShift:
Valid Driving License:
Hazardous Material(s):
Official account of Jobstore.
Job Description
The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager or CRD, the person ensures compliance of study conduct with ICH/GCP and country regulations, Company policies and procedures, quality standards and adverse event reporting requirements internally and externally. Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites. Actively develops and expands the territory for clinical research, finding and developing new sites. Participates in internal meetings and workstreams as SME for monitoring processes and systems.
Responsibilities include, but are not limited to:
•Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
•Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
•Gains an in-depth understanding of the study protocol and related procedures
.•Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
•Participates & provides inputs on site selection and validation activities.
•Performs remote and on-site monitoring & oversight activities using various tools to ensure:
oData generated at site are complete, accurate and unbiased.
oSubjects’ right, safety and well-being are protected.
•Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
•Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
•Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
•Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM, TA Head and CRD as needed.
•Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites.
•Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
•Contributes strongly to CRA team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.
•Supports and/or leads audit/inspection activities as needed.
•Following the country strategy defined by CRD and CRA manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities.
•Mentors / buddies junior CRAs on process/study requirements and performs co-monitoring visits where appropriate.
CORE Competency Expectations:
•Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.
•Excellent understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines. •Excellent understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
•Demonstrated ability to mentor/lead.
•Hands on knowledge of Good Documentation Practices.
•Proven Skills in Site Management including independent management of site performance and patient recruitment.
•Demonstrated high level of monitoring skill with independent professional judgment.
•Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.
•Ability to understand and analyze data/metrics and act appropriately, also in a virtual environment.
•Experience with conducting site motivational visit designed to boost site enrollment.
•Capable of managing complex issues, works in a solution-oriented manner.
•Performs root cause analysis and implements preventative and corrective action.
•Capable of mentoring junior CRAs on process/study requirements and is able to perform co-monitoring visits where appropriate.
Behavioural Competency Expectations:
•Effective time management, organizational and interpersonal skills, conflict management, problem solving skills.
•Able to work highly independently across multiple protocols, sites and therapy areas.
•High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment.
•Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
•Demonstrates commitment to Customer focus.
•Works with high quality and compliance mind-set.
•Positive mindset, growth mindset, capable of working independently and being self-driven
•Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices.
Experience Requirements:
Required:•Min. 4 years of direct site management (monitoring) experience in a bio/pharma/CRO.
Travel
• Ability to travel domestically and internationally approximately 65%-75% of working time. Expected travelling ~2-3 days/week.
• Current driver’s license preferred (Must have in certain countries).
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
HybridShift:
Valid Driving License:
Hazardous Material(s):
Official account of Jobstore.
Job Description
We are looking for a Sr. Specialist Global Safety & Environment, reporting to the Manager Safety & Environment of LATAM, the Sr. Specialist is responsible for managing the development and implementation of environmental, health and safety programs for Commercial Operations (Fleet Safety, Offices and Warehouses) including both field sales and office facilities.
Also, the Sr. Specialist is responsible for all applicable EHS regulations in Colombia. The Sr. Specialist must be fulfilled and licensed to design, implement, and execute the EHS management system in Colombia, is the person to lead the design, implementation, and execution of the System, in accordance with the established in Decree 1072 of 2015 and Resolution 0312 of 2019.
This role will partner with site leadership and facilities to integrate effective and efficient EHS programs in alignment with business goals and values. Monitors and reports on EHS performance and develops strategies for continuous improvement and sustainable compliance to governing regulations and programs.
We offer attractive career opportunities within the EHS function globally and fosters individual career development both through internal trainings and external educational programs and certifications. You will have the opportunity to work with a variety of EHS experts and pharmaceutical professionals, translating safety relevant information into best practices and communicating across all levels of the organization.
Required:
Preferred:
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
HybridShift:
Valid Driving License:
Hazardous Material(s):
Official account of Jobstore.
Job Description
Position Overview:
The Trial Manager creates and ensures the successful execution of the clinical data management strategy for assigned trials within a specific drug/vaccine program. Develops and manages project plans which span from protocol development through database lock, archiving, and submission deliverables where applicable. Collaborates with appropriate functional areas to align resources and ensure all aspects of the project plan are executed on time and with appropriate quality. Agrees/arbitrates deliverable-based commitments based on detailed knowledge of trial complexity and requirements. Manages change, customer, and stakeholder expectations, facilitates cross-functional decision making, and performs risk management. Represents functional areas and GDMS on cross-functional trial teams and in other trial-level development forums.
Under the guidance of more senior staff, may serve as the data management lead or perform a support role for filing programs. Participates in the development of, and ensures adherence to, clinical data management procedures. Interacts with staff across sites, countries, and time zones.
Primary activities include but are not limited to:
1. Develops detailed project plans for the collection, review, and cleaning of all clinical data for assigned trials within a specific drug / vaccine program. Data includes, but is not limited to, case report form (CRF) data, lab data, other external data, biomarker data, and clinical outcomes assessments.
2. Serves as project manager of all clinical data management activities for trials as assigned. Under the guidance of more senior staff when appropriate, uses excellent interpersonal, negotiating, and project management skills to perform and manage the following tasks:
• Project planning, initiation, execution, change control, and closing.
• Project team development, project team leadership, meeting management, and resource coordination.
• Risk management planning (i.e., risk identification, analysis, response planning, monitoring, and control), including escalation as necessary.
• Management of customer / stakeholder expectations; facilitation of cross-functional decisions.
3. Defines trial-level requirements for quality data collection and validation at the trial level.
• Reads and interprets the clinical protocol from a clinical data management perspective.
• Provides clinical data management input into trial design, as appropriate, ensuring operational feasibility.
• Engages with key stakeholders and subject matter experts to assess complexity, define trial-level data management requirements and inputs (including timing), and confirm all data management deliverables and services required for a trial.
• Ensures appropriate use of standards and project-level consistency of database design, data collection, and validation.
• Facilitates assessment and processing of standards and change requests.
• Approves trial-level data validation plan (including project and protocol specific data validation elements).
4. Manages trial-level data quality and completion of database lock and post-database lock activities:
• Monitors overall status and quality of data being collected during the in-life portion of a trial.
• Engages with key stakeholders and subject matter experts to refine data management tools and validation plans, as appropriate.
• Ensures activities required to achieve database lock (or data extraction) are completed by appropriate, responsible functional area.
• Ensures timely archival of trial data and documentation.
• Ensures timely decommissioning of clinical data management technologies.
5. Accountable for ensuring the successful execution of delivery of data management services provided by external partners engaged for outsourced trials, as assigned
6. Supports site and sponsor audits, as appropriate
7. Identifies and supports improvements to data collection and data management processes and tools.
#ONEGDMS
Position Qualifications:
Education/Experience (ex-Us, subject to local requirements): B.A. or B.S. degree, preferably in life sciences, computer science, or related discipline, with at least 3 years’ experience in Clinical Data Management, medical research, or database design and development, with at least 1 year experience working with formal project management tools and processes
OR
Associates Degree with at least 5 years’ professional experience in clinical data management. Medical research, or database design and development, with at least 1 year experience working with formal project management tools and processes
OR
High School Diploma (or equivalent) with at least 8 years’ professional experience in clinical data management; …
Knowledge and Skills:
1. Understanding of the clinical research process with in-depth knowledge of the Clinical Data Management lifecycle.
2. Familiar and comfortable with database concepts and tools to manage, extract, and report data.
3. Strong organization, leadership, and management skills.
4. Exceptional communication skills (oral and written) with the ability to communicate with both the technical and business areas.
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
HybridShift:
Valid Driving License:
Hazardous Material(s):
Official account of Jobstore.
Job Description
Durante más de un siglo hemos estado inventando para la vida, desarrollando fármacos y vacunas para muchas de las enfermedades más difíciles del mundo. Actualmente, nuestra empresa sigue estando a la vanguardia de la investigación para ofrecer soluciones de salud innovadoras y avanzar en la prevención y tratamiento de enfermedades que amenazan a personas y animales de todo el mundo.
Practicante Estrategia e Innovación
¿Estás listo para poner en práctica tus conocimientos, aprender e impactar en millones de vidas?
¡Si es así, esta es la oportunidad perfecta para que hagas parte de una empresa que le apuesta a la innovación, la experimentación y el crecimiento!
Nuestro equipo de Estrategia E Innovación está transformando la forma en que entendemos a nuestros pacientes y sus necesidades. Trabajando de forma multifuncional, estamos inventando nuevas formas de comunicar, medir e interactuar con nuestros clientes y pacientes a través de canales y tecnologías digítales apalancándonos de capabilities como Strategic Thinking, Data analytics, digital mindset, Innovación entre otros.
El Practicante de Estrategia e Innovación será el soporte principal para la gerencia de Estrategia e Innovación del cluster de Colombia & Ecuador.
Estas son algunas de las funciones que realizarás como Practicante de Estrategia e Innovación:
Lo que debes tener en cuenta para aplicar:
¡Queremos animarte a que aportes tu pensamiento inquieto para que Juntos sigamos Inventando para la vida, mientras te inspiramos en este importante paso para el inicio de tu carrera profesional!
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Intern/Co-op (Fixed Term)Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
HybridShift:
Valid Driving License:
Hazardous Material(s):
Official account of Jobstore.
Job Description
Durante más de un siglo hemos estado inventando para la vida, desarrollando fármacos y vacunas para muchas de las enfermedades más difíciles del mundo. Actualmente, nuestra empresa sigue estando a la vanguardia de la investigación para ofrecer soluciones de salud innovadoras y avanzar en la prevención y tratamiento de enfermedades que amenazan a personas y animales de todo el mundo.
Practicante de Comunicaciones con énfasis Diseño y Medios Audiovisuales del área de Global Data Operations
¿Estás listo para poner en práctica tus conocimientos, aprender e impactar en millones de vidas?
¡Si es así, esta es la oportunidad perfecta para que hagas parte de una empresa que le apuesta a la innovación, la experimentación y el crecimiento
Estas son algunas de las funciones que realizarás como Practicante de Comunicaciones con énfasis Diseño y Medios Audiovisuales:
-Fortalecer los canales de comunicación del área de Global Data Operations.
-Apoyo en la elaboración de contenidos multimedia en proyectos locales y algunas iniciativas globales para el área.
- Búsqueda activa de información relevante en la industria global del manejo de datos clínicos.
- Creación de contenido multimedia.
-Manejo de plataformas de comunicación (Viva Engage, Share Points, Bulletins, entre otros)
- Apoyo en estrategias de Marketing Digital
- Trabajo colaborativo con diseño gráfico y comunicación social
- Creación de piezas gráficas y literarias
- Medición del impacto de las publicaciones (Análisis cuantitativo)
- Creación y mantenimiento de comunidad a través de redes sociales corporativas.
- Creación de marca e implementación de actividades de fortalecimiento de marca en equipos locales y globales.
Adicional al espacio de práctica y las oportunidades de aprendizaje y desarrollo en Global Data Operations el estudiante tiene la oportunidad de crear un networking a nivel local y global, con los diferentes centros de datos en el mundo (US, Suiza, Polonia, China, Argentina) además de tener el espacio para aplicar todos los conceptos relacionados con social media.
Lo que debes tener en cuenta para aplicar:
Contar con el aval de tu universidad para realizar tus practicas universitarias.
Ser estudiante de Diseño Gráfico, Comunicador Social, Publicidad, Medios Audiovisuales.
Conocimiento en estrategia de redes sociales.
Excelente redacción y ortografía.
Manejo de Office (Word, Excel, Power Point, Adobe)
Conocimiento intermedio en programas de diseño en general (Suite Adobe)
Inglés intermedio
Preferiblemente con disponibilidad para trabajar de lunes a viernes de 8:00am a 5:00pm de manera presencial todos los días.
¡Tener todas las ganas y motivación para aprender!
¡Queremos animarte a que aportes tu pensamiento inquieto para que Juntos sigamos Inventando para la vida, mientras te inspiramos en este importante paso para el inicio de tu carrera profesional!
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Intern/Co-op (Fixed Term)Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Not ApplicableShift:
Valid Driving License:
Hazardous Material(s):
Official account of Jobstore.
Job Description
This role is primarily accountable for the end-to-end performance and project management for assigned protocols in compliance with country regulations, policies and procedures, quality standards and adverse event reporting requirements internally and externally. The Clinical Research Manager could be responsible for a particular study for several countries in a cluster.
CORE Competency Expectations
Experience Requirements:
Required:
1. 5-6 years of experience in clinical research - CRA Experience preferred
2. Educational Requirements:
Bachelor degree in Science (or comparable)
Preferred: Advanced degree, (e.g., Master degree, MD, PHD
3. Fluent Spanish and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.
4. Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
5. Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
6. Knowledge in Project Management and site management.
7. Strong organizational skills with demonstrated success required.
8. Requires ability to make decisions independently and oversee important activities relevant to clinical research activities according to predetermined global policies and commitments with the support, oversight, and supervision of the TA Head /CRD
9. Requires strong understanding of local regulatory environment
10. Strong scientific and clinical research knowledge is required
11. Strong understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously.
12. Communicates effectively and builds a collaboration spirit in a remote/virtual environment and across countries, cultures and functions
13. Strategic thinking
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
No Travel RequiredFlexible Work Arrangements:
HybridShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
noOfficial account of Jobstore.
Job Description
Practicante Clinical Trial Operations - Finanzas
¿Estás listo para poner en práctica tus conocimientos, aprender e impactar en millones de vidas?
¡Si es así, esta es la oportunidad perfecta para que hagas parte de una empresa que le apuesta a la innovación, la experimentación y el crecimiento!
El practicante de Global Clinical Trial Operations Podrá trabajar en una unidad transversal a las diferentes áreas de negocio, siendo el principal apoyo a los diferentes roles del área, lo cual le va a permitir tener una visión completa de los estudios clínicos, incluyendo el área de finanzas, y participando en proyectos para la mejora de procesos del área. También tendrá la posibilidad de aprender de un equipo multidisciplinario con diferentes habilidades y conocimientos que incluye médicos, enfermeros, bacteriólogos.
Estas son algunas de las funciones que realizarás como practicante de Clinical Trial Operations
Esta práctica será un buen reto para aprender sobre el manejo financiero de las investigaciones y estudios clínicos en Colombia.
El enfoque del programa será en el conocimiento de los procesos financieros y el manejo de proyectos desde el enfoque de los estudios clínicos.
Responsabilidades
- Trabajar con los diferentes roles del área para cumplir con los procesos financieros necesarios en el marco de la investigación clínica.
- Buscar oportunidades en el proceso de investigación clínica en Colombia y proponer mejoras en cada ámbito.
- Participar de reuniones de seguimiento para cada uno de los pasos en el proceso financiero de investigación clínica.
- Apoyar el proceso de facturación a los centros de investigación.
-Participación en proyectos de mejora del área de Global Clinical Trials Operations.
- Facturación de Estudios Clínicos
Lo que debes tener en cuenta para aplicar:
Ser estudiante de Ingeniería Biomédica, Ingeniería Industrial o Administración de empresas
Manejo de office (Word, excel, power point)
Inglés intermedio/avanzado
¡Queremos animarte a que aportes tu pensamiento inquieto para que Juntos sigamos Inventando para la vida, mientras te inspiramos en este importante paso para el inicio de tu carrera profesional!
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Intern/Co-op (Fixed Term)Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
HybridShift:
Valid Driving License:
Hazardous Material(s):
Official account of Jobstore.
Job Description
Under the direction of the Global Data Operations leadership, the Global Data Operations Manager is responsible for leading clinical data managers and tactical operations tasks within a Data Management Center. They are responsible for ensuring the consistent execution of quality processes and managing the workload and development of their direct staff. Encourages effective interaction of Data Management Center staff with business partners to achieve common objectives.
Primary activities include, but are not limited to:
Direct Line Management of clinical data managers
Develops career plans
Makes work assignments
Conducts periodic skill assessments
Annual performance appraisals
Coaches and provides ongoing feedback for performance
Provides rewards and recognition
Sets priorities
Provides developmental opportunities
Manages training compliance
Escalates to appropriate leadership/management as needed as risks and needs arise in the business
Increases functional effectiveness by supporting departmental efforts to simplify and standardize procedures to the greatest extent possible, sharing best practices and participating in continuous improvement efforts.
Participates in Global Data Operations Business Excellence Networks as needed
Participates in management and functional area meetings, contributing expertise, when necessary, through formal or informal presentations.
Keeps abreast of process and technology changes both within and outside of the companythat may impact staff.
May support any other projects or perform any other data management task deemed appropriate by management.
Internal Candidates:
B.A. or B.S. degree, preferably in life sciences, computer science, or Health care related discipline.
At least 3 years’ experience in Clinical Trials
At least 1 year’ experience in People Management or equivalent demonstrated leadership
Advance English Level
Intermediate Excel Level
Open to all organizational areas.
People management skills.
Minimum one year in your current position
External Candidates:
B.A. or B.S. degree, preferably in Medicine, Pharmacy, Nursing, Biological Sciences, Health care related discipline, Sciences Disciplines.
An overall working knowledge of the clinical research or Pharma Industry
At least 3 years’ experience in Pharma Industry
Demonstrate 2 years of experience as People Manager Or experience as Team Leader of more than 5 people.
Advance English Level
Intermediate Excel Level
Desire AI or Machine Learning knowledge.
Knowledge and Skills:
Knowledge of the clinical development process
Demonstrated leadership and project management skills
Strong organizational, communication, negotiating and problem-solving skills
Current Employees apply HERE
Current Contingent Workers apply HERE
Secondary Language(s) Job Description:
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Shift:
Valid Driving License:
Hazardous Material(s):
Official account of Jobstore.
Job Description
#ONEGDMS Under the direction of the applicable management, the Clinical Data Management Analyst is responsible for executing end to end data management activities pertaining to clinical trials, including but not limited to; data management tool and system development, validation and maintenance, data collection, data integrity review and reconciliation, query management, medical coding, and database lock preparation, in compliance with our company Standard Operating Procedures and guidelines.
Education and Experience:
At least B.A. or B.S. degree, Nursing, Veterinary, Dentistry, Bacteriology, Pharmaceutical Chemistry, Biomedical Engineering and system engineering, Biologist, microbiologist, health care related with 2 years of formal experience.
Knowledge and Skills:
·Excellent planning and time management skills
·Able to work under pressure in a changing flexible environment
·Good communication skills
·Fluent oral and written English skills.
·Background of data science skills in the context of healthcare is preferred
- Fixed Term Contract
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Project Temps (Fixed Term)Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
HybridShift:
Valid Driving License:
Hazardous Material(s):
Official account of Jobstore.
Job Description
Individual Case Medical Review (ICMR)
The Scientist Level Clinical Safety Scientist (CSS) is responsible for support of safety reporting in clinical trials conducted in multiple therapeutic areas as part of investigational product development programs across early and late-stage development. Assists the protocol lead in safety reporting activities for multiple clinical trials. The CSS may support collaboration with cross-functional colleagues within clinical development, clinical operations, case processing and medical safety review.
Key Responsibilities:
Qualifications & Skills
Education Requirement:
Preferred:
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Project Temps (Fixed Term)Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
HybridShift:
Valid Driving License:
Hazardous Material(s):
Official account of Jobstore.
Job Description
Durante más de un siglo hemos estado inventando para la vida, desarrollando fármacos y vacunas para muchas de las enfermedades más difíciles del mundo. Actualmente, nuestra empresa sigue estando a la vanguardia de la investigación para ofrecer soluciones de salud innovadoras y avanzar en la prevención y tratamiento de enfermedades que amenazan a personas y animales de todo el mundo.
Practicante Análisis de Datos (Matemáticas-Estadística)
¿Estás listo para poner en práctica tus conocimientos, aprender e impactar en millones de vidas?
¡Si es así, esta es la oportunidad perfecta para que hagas parte de una empresa que le apuesta a la innovación, la experimentación y el crecimiento!
Estas son algunas de las funciones que realizarás como practicante de Análisis de Datos:
Brindar soporte en diferentes proyectos enfocados en la Gestión y análisis de Datos.
Apoyar al equipo de Workload de Global Data Operations analizando la carga de trabajo y proponiendo cambios que permitan la mejora de procesos y asignación de tareas en los diferentes roles.
Analizar tendencias y desarrollar metodologías para obtener datos actualizados.
Análisis y presentación de datos ante directores del área relacionados a la carga de trabajo de los diferentes roles del departamento.
Creación de modelos predictivos.
Mantenimiento, visualización y análisis de base de datos
Lo que debes tener en cuenta para aplicar:
Contar con el aval de tu universidad para realizar tus practicas universitarias.
Ser estudiante de Matemáticas o Estadística
Conocimientos en lenguajes de programación (VBA, Python)
Manejo avanzado de Excel
Conocimientos intermedios en PowerBI
Inglés intermedio
Preferiblemente con disponibilidad para trabajar de lunes a viernes de 8:00am a 5:00pm.
¡Queremos animarte a que aportes tu pensamiento inquieto para que Juntos sigamos Inventando para la vida, mientras te inspiramos en este importante paso para el inicio de tu carrera profesional!
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Intern/Co-op (Fixed Term)Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Not ApplicableShift:
Valid Driving License:
Hazardous Material(s):
Official account of Jobstore.
Job Description
Durante más de un siglo hemos estado inventando para la vida, desarrollando fármacos y vacunas para muchas de las enfermedades más difíciles del mundo. Actualmente, nuestra empresa sigue estando a la vanguardia de la investigación para ofrecer soluciones de salud innovadoras y avanzar en la prevención y tratamiento de enfermedades que amenazan a personas y animales de todo el mundo.
Practicante Análisis de Datos (Ingeniería Industrial)
¿Estás listo para poner en práctica tus conocimientos, aprender e impactar en millones de vidas?
¡Si es así, esta es la oportunidad perfecta para que hagas parte de una empresa que le apuesta a la innovación, la experimentación y el crecimiento!
Estas son algunas de las funciones que realizarás como Practicante de Análisis de Datos:
Brindar soporte en diferentes proyectos enfocados en la Gestión y análisis de Datos.
Apoyar al equipo de Workload de Global Data Operations analizando la carga de trabajo y proponiendo cambios que permitan la mejora de procesos y asignación de tareas en los diferentes roles.
Caracterización de procesos manejados dentro del grupo de Cargas de trabajo y sus Workstreams.
Extracción y mantenimiento de bases de datos. Visualización y análisis gráficos basados en datos.
Trabajo colaborativo con los Directores del área y diferentes roles del departamento para la apropiada asignación de recursos.
Aplicación de la gestión y control de calidad dentro del equipo de Workload.
Programación para optimización de procesos.
Gestión de proyectos.
Creación de modelos predictivos.
Lo que debes tener en cuenta para aplicar:
Contar con el aval de tu universidad para realizar tus practicas universitarias.
Ser estudiante de Ingeniería Industrial.
Conocimientos en lenguajes de programación (VBA, Python)
Manejo avanzado de Excel
Conocimientos intermedios en Power BI
Inglés intermedio
Preferiblemente con disponibilidad para trabajar de lunes a viernes de 8:00am a 5:00pm.
¡Queremos animarte a que aportes tu pensamiento inquieto para que Juntos sigamos Inventando para la vida, mientras te inspiramos en este importante paso para el inicio de tu carrera profesional!
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Intern/Co-op (Fixed Term)Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Not ApplicableShift:
Valid Driving License:
Hazardous Material(s):
Official account of Jobstore.
Job Description
Individual Case Medical Review (ICMR)
The Scientist Level Clinical Safety Scientist (CSS) is responsible for support of safety reporting in clinical trials conducted in multiple therapeutic areas as part of investigational product development programs across early and late-stage development. Assists the protocol lead in safety reporting activities for multiple clinical trials. The CSS may support collaboration with cross-functional colleagues within clinical development, clinical operations, case processing and medical safety review.
Key Responsibilities:
Qualifications & Skills
Education Requirement:
Preferred:
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Project Temps (Fixed Term)Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
HybridShift:
Valid Driving License:
Hazardous Material(s):
Official account of Jobstore.
Job Description
¿Estás listo para poner en práctica tus conocimientos, aprender e impactar en millones de vidas?
¡Si es así, esta es la oportunidad perfecta para que hagas parte de una empresa que le apuesta a la innovación, la experimentación y el crecimiento!
El Practicante de Comercialización tendrá la invaluable oportunidad de administrar procesos e implementar mejoras en el área de comercialización de la compañíá. Interactuarás con áreas como marketing, ventas, finanzas, cartera, regulatorio, y supply chain, para obtener información y buscar integrar más los procesos, así como robustecer los dashboards de comercialización. También tendrá la posibilidad de aprender y mejorar competencias sobre análisis de datos, afianzar tus conocimientos en herramientas de visualización, así como desarrollar tu capacidad de liderazgo y de toma de decisiones.
Estas son algunas de las funciones que realizarás como Practicante de Comercialización:
Apoyar en distintos procesos para la implementación de mejoras del área.
Participación en las reuniones de equipo con el fin de ampliar la visión de un área comercial.
Brindar soporte en la automatización y elaboración de Dashboards.
Mejoramiento y automatización de Dashboards del área relacionadas a KPIs de cuentas clave y desempeño de los KAMs
Realizar seguimiento en la consolidación de las proyecciones de ventas enviadas por el equipo de KAMs, representantes de oncología y vacunas.
Desarrollar análisis del mercado para dar apoyo en la toma de decisiones con base en las herramientas de la compañía.
Creación de clientes e ingreso en plataforma interna.
Participación en la ejecución de proyecto para el área de comercialización, de acuerdo con los intereses del estudiante y las necesidades del área.
¡Tener todas las ganas y motivación para aprender!
Lo que debes tener en cuenta para aplicar:
Contar con el aval de tu universidad para realizar tus practicas universitarias.
Ser estudiante de Administración de Empresas, Economía o afines, Ingeniería Industrial y/o Marketing.
Interés y conocimiento en desarrollo de Dashboards.
Excel avanzado.
Plus conocimientos en PowerBI
Inglés intermedio/avanzado
Preferiblemente con disponibilidad para trabajar de lunes a viernes de 8:00am a 5:00pm
¡Queremos animarte a que aportes tu pensamiento inquieto para que Juntos sigamos Inventando para la vida, mientras te inspiramos en este importante paso para el inicio de tu carrera profesional!
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Intern/Co-op (Fixed Term)Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
HybridShift:
Valid Driving License:
Hazardous Material(s):
Official account of Jobstore.
If you don't have a Malaysian citizenship, but are living in Malaysia or if you are planning to move to Malaysia and are looking for jobs that can sponsor you, it is up to each individual employer on how it handles international candidates. We encourage you to read our blog post to help provide more information: 7 Easy Steps to Find Jobs in Malaysia As A Foreigner.
Have you tried following up? If you did not follow up with an email or phone call, how do you determine if the company received your job application? Enquire where they are in the review process and and then ask if they received your submission. While it would be great to receive a response from the company, sometimes it doesn’t happen. Take the initiative to follow to ensure your application has been received.
The period of the application process will vary, depending on the type of job you are applying for and your previous employment experience.
There are 6 position levels and each level can be associated with a salary range and different types of job titles. Jobs levels can be categorised into: non-executive, fresh/entry level, junior executive, senior executive, manager and senior manager.
Within Jobstore, there are hundreds of variations of jobs. Read through the job descriptions to find out about the typical responsibilities and employers for each job, so you can see what’s involved and who might employ you.