Total 7 job vacancies by 3550 MSD RDC Costa Rica SRL

Job Description

Exciting Opportunity to Lead Global Data Operations Team. Are you ready to take on a leadership role in our Global Data Operation?  We are seeking an exceptional Global Data Operations Manager to lead a critical part of our Data Management Center (DMC). If you are passionate about driving excellence and fostering talent, this is the opportunity for you.

His/Her tasks depend on the Process/Responsibilities assigned.

Primary activities include, but are not limited to:

• Leadership and Execution: As a Global Data Operations Manager, you will oversee the flawless execution of quality global procedures while effectively managing workload and resource allocation. Your guidance will ensure the achievement of our common objectives.
• Talent Development: Foster the comprehensive development of your team through career planning, skill assessments, performance coaching, and recognition programs. Provide growth opportunities and equip associates with the training and mentoring needed to succeed.
• Workload Optimization: Maximize staff effectiveness and maintain work-life balance by aligning priorities, estimating task complexity, and proactively addressing obstacles. Elevate complex issues to the appropriate management level for prompt resolution.
• Process Excellence: Support continuous improvement efforts, simplifying procedures, and sharing best practices to enhance functional effectiveness.
• Process Ownership: Take on the role of GDO Manager Process Owner (PO) within the DMC. Lead your team in specific professional or business activities such as process compliance, training, quality, metrics, and more to achieve our business goals.
• Collaboration and Knowledge: Engage in management and cross-functional meetings, contributing your expertise through formal or informal presentations. Stay updated on evolving processes and technologies, both internally and externally, to ensure staff readiness.
• Flexibility and Innovation: Embrace new initiatives beyond GDO, including cross-functional, cross-divisional projects, and industry collaborations. Support additional projects or tasks as assigned by management.

Qualifications:

• Education: Bachelor's degree, preferably in Medicine, Pharmacy, Nursing, Biological Sciences, or a related healthcare discipline.
• Experience: Minimum of 4 years' experience in drug surveillance, data management, or clinical/medical research. Supervisory or management experience is highly desired.
• Skills: Possess a comprehensive understanding of the clinical development process or drug surveillance. Exceptional communication, project management, decision-making, and problem-solving skills. Build effective relationships and lead teams with influencing and development skills. Thrive in a changing environment and remain flexible under pressure.

Join Our Team, take the next leap in your career by joining our team as a Global Data Operations Manager. Together, we will drive excellence and make a significant impact in the field of healthcare.

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Description

Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards.

Primary Responsibilities:

• Responsible for the testing and validation of Electronic Data Capture (EDC) systems, in accordance with company Software development lifecycle (SDLC).  

• Individual should have general understanding of SDLC, and Good Testing Procedures.​

• Perform execution of standard and trial specific test scripts and record test data and test results; Edit check Matrix testing.

• Creation of and the execution of standard and trial specific test scripts.

• Develops knowledge in programming and system analysis and testing within Global Data Management and Standards (GDMS) applications.

• May support the testing of tools and applications; including creating Test Plan, Test Scripts and execution of test scripts.

• Ensures all testing documentation is stored in electronic trial master file.

Education Minimum Requirements:

• At least B.A. or B.S. degree, preferably in mathematics, science, a health care related discipline, or computer science.

Required Experience and Skills:

• Database design and development knowledge. 

• An overall working knowledge of the clinical development process.

• Knowledge of database structures and available tools to manage, extract, and report data is preferred. 

• Exceptional communication skills (oral and written) with the ability to communicate with both the technical and business areas.

• Exceptional organizational and problem-solving skills. 

• Ability to work cross functionally and as part of a team.

• Able to work under pressure and change environment with flexibility.

Preferred:

• System Development Lifecycle Management / system validation knowledge

• Knowledge of Python, Java, C#, Jira, Power BI, Github, SQL

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Description

Requirements

Education: B.A. or B.S. degree, preferably in IT, mathematics, science, a healthcare-related discipline, or computer science; or relevant skills and experience.

Language: English Business Proficient

Qualifications, Skills & Experience

Skills & Experience

• Knowledge of database structures and available tools to manage, extract, report, and warehouse data.
• Desirable knowledge of database structures and available tools to manage, extract, report, and warehouse data (SQL-PL/SQL scripting).
• Desirable 2 years of database development or data programming experience
• Desirable technical proficiency in a Clinical Data Management Systems (i.e., InForm, Inform Architect, Central Designer).
• 2+ years’ experience in System Development Lifecycle Management / system validation knowledge.
• Desirable experience with reporting tools such as SAS, Cognos or JReview.
• Desirable experience in eCRF generation for site documentation and downstream regulatory compliance deliverables.
• Ability to collaborate and communicate with cross functional stakeholders to interpret and ensure quality report specifications and input to report development.
• Solid knowledge of MS Windows/Office software and exposure to web-based applications.
• Effective communication skills (oral and written) with the ability to communicate with both the technical and business areas.
• Strong organizational and critical thinking skills.
• Keen sense of urgency and customer focus.
• Ability to work cross functionally and as part of a team.
• Able to work independently, under pressure and change environment with flexibility.

Activities may include, but are not limited to:

• Creates and develops clinical databases and data transfer files according to written specifications.
• Participates in the review of electronic case report forms (eCRF) and edit checks, database development, programming of edit checks, and scripts to aid in transfer of electronic data files into the Clinical Data Management System (CDMS). 
• Interface with members of study teams, including external CROs/Vendors where applicable, to integrate study team requirements into all deliverables.
• Responsible for reporting deliverables supporting data cleaning and verification and any external data captured in clinical studies.
• Creates and reviews reporting specifications to ensure high quality deliverables, meet SDTM structure requirements and the needs of the business.
• Participates in the review of standard and template reports, and scripts to aid in the review of data to ensure a quality database.
• Participate in database Archiving and Decommissioning activities in support of multiple clinical programs (with Vendors interaction).

Participates in the following activities:

• Interface with members of study teams and key stakeholders, to integrate requirements into all deliverables.
• Ensures adherence to clinical database standards, SDTM structures, SOPs, and Process Guidelines.
• Participates in activities including, but not limited to, task forces, testing of new systems and helps coordinate technical initiatives.

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Description

The Safety Data Specialist (SDS) is responsible for processing adverse experience (AE) information in the global safety system for investigational and/or marketed products, under the direction and supervision of a GPVCM Manager. The SDS performs triage, analysis and interpretation of AE data following our Company Standard Operating Procedures (SOPs) and guidelines. The SDS should understand the importance of high quality and compliant AE case management. The SDS should also have a clear perception of case management processes, adhere to corporate policies and follow the company’s Ways of Working, including leadership behaviors.

Responsibilities and Primary Activities (may include but are not limited to):

• Process AE reports and meet Key Performance Indicators (KPIs).

• Index AE documents pushed from Central Receiving Mailboxes to the Indexing tool with required attributes.

• Provide medical translation service to meet the country regulatory requirement.

• Clarify discrepancies in the incoming information to achieve case consistency or accuracy.

• Complete training and independence assessment activities for GPVCM specialists.

Education and other Qualifications:

• Bachelor’s degree or above in Health Care or job-related disciplines.

• Advanced writing/reading of medical content and intermediate speaking/listening English language skills.

• Basic IT skills (Outlook, Excel, browsing tools).

Levels required for Core Competencies:

• Data Analysis, Interpretation & Communication: Demonstrate familiarity and self-management based on analytical skills and detail orientation to achieve main business objectives.

• Competitive Decision Making & Execution: Utilize appropriate resources to make accurate and timely decisions that will impact positively own and others’ work.

• Collaboration & Partnering: Have a common sense of joint responsibility and collaboration by demonstrating willingness and interest to gain new knowledge that can positively impact the day-to-day business. 

• Disease Area Knowledge (Sub Competencies):  Utilize medical/clinical knowledge to quickly adjust to new core responsibilities.

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Description

This role provides administrative and operational support to LATAM Head and Managers from Global Data Management Team Local and regional on operational activities, administrative tasks, logistic support, meeting management and interaction with other internal and external stakeholders for business purposes (HR, Talent Attraction, Procurement, IT, Legal, Compliance, Facilities, Security, etc.…) and 3rd parties. This role will report the GDO LATAM Regional Head supporting for Digital Transformation, Innovation, Communication and Special project.

The job primary duties include but are not limited to

• Support the leadership team in the administration of various administrative processes, special projects, headcount, budgeting, and other projects in accordance with established standard operating procedures for the Company, Division, and department.
• Logistics Planning and scheduling agenda, coordinating meetings, interviews and other similar activities, book meeting room, send invitations, etc. Operational Support to strategic projects, following up to deadlines, contacting stakeholders and vendors, supporting solutions in internal platforms, sharing information in internal channels as requires, collecting metrics from different channels, creating and following with surveys and other metrics related platforms/tools, contacting IT and other system related stakeholders to solve issues, to propose communications in Outlook, yammer and other channels when required.
• Help lead and coordinate events designed to maintain an inclusive culture with engaged and passionate employees, including community outreach and volunteer events.
• Keep meeting records and minutes, spotting and sharing Highlights with stakeholders. Organize travel arrangements, prepare itineraries and confirm logistics.
• Act as a point of contact to give administrative support and interaction with internal stakeholders (RH, IT, Compliance, Procurement, Talent Attraction, Facilities, other executive assistants, etc…) Identification of the Procurement staff and processes that support the set up and follow up of 3er parties & suppliers Purchase Orders..
• Tracking and compliance of payment process, invoice reception, purchase orders and charge backs from specific projects
• Preparing, processing, and reconciling expense reports, purchase orders, and payment requests, as needed. Leading the work of tracking budgets and costs.
• To update Distribution lists on Outlook, Teams & Yammer. To upload information in specific platforms when required and follow up communication plans in Outlook, Stream, Forms, White Board, Teams, Yammer, etc… Understanding role activities and ensure compliance.
• Managing teamsites, electronic files, and other data in a systematic and detailed manner for enduring use.
• Maintaining appropriate filing system to provide prompt retrieval of all reports, correspondence, and other documentation while maintaining compliance related to company retention schedules and legal holds. Includes collection, organization and archival of documentation, including maintenance of staff Curriculum Vitaes (CVs).
• Preferred Experience in emailing and other written and communications graphic design., and also digital & tech savvy or curious.
• Teamwork, flexibility and self-awareness

Education:

Business Administrative degree or related discipline required.

Required Skills & Experience:

• Minimum three (3) years administrative experience.
• Proficient computer skills (MS Teams, SharePoint management, Excel, Power Point, Word, etc.) and operation of other related programs, including proficient knowledge of SAPS Comet and other company systems.
• Ability to prepare and assist with sophisticated PowerPoint presentations and manipulate/work with advanced Excel spreadsheets.
• Exceptional level of administrative, organizational, planning and follow-up skills with demonstrated accuracy. Must be diligent and proactive in anticipating needs and able to problem solve through investigation and solution identification.
• Exceptional interpersonal skills and the ability to manage relationships with internal and external parties is essential, including displaying flexibility and sensitivity with colleagues across other geographies, languages, and cultures.
• Effective business communications - both written and oral to interact with company executives, managers, and employees. communications graphic design., and also digital & tech savvy or curious
• Self-motivated and self-directed, excellent in work planning and coordination and time management.
• Ability to make a positive contribution as demonstrated by learning new skills and making suggestions for process/procedure improvement.
• Ability to work toward enterprise goals and fostering a work environment based on trust, sharing and collaboration.
• Ability to commute onsite 3 days/week (M-F).
• Experience working with sensitive/confidential documents, preferred.

#ONEGDMS

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Description

Activities may include, but are not limited to:

• Creates and develops clinical databases and data transfer files according to written specifications.

• Leads and participates in the review of electronic case report forms (eCRF) and edit checks, database development, programming of edit checks, and scripts to aid in transfer of electronic data files into the Clinical Data Management System (CDMS). 

• Interface with members of study teams, including external CROs/Vendors where applicable, to integrate study team requirements into all deliverables.

• Responsible for all data mapping deliverables including SDTM structure set-up and transformation maps to support multiple clinical programs.

• Creates and develops mapping specifications to meet SDTM structure requirements utilizing E2E visibility tools to ensure quality and timeliness of data flow.

• Leads and participates in developing transformation logic, and scripts to aid in the flow of data downstream for Analysis and Reporting.

• Responsible for reporting deliverables supporting data cleaning and verification and any external data captured in clinical studies.

• Coordinates data reporting activities for multiple clinical programs.

• Creates and reviews reporting specifications to ensure high quality deliverables, meet SDTM structure requirements and the needs of the business.

• Leads and participates in the review of standard and template reports, and scripts to aid in the review of data to ensure a quality database.

• Assumes the responsibilities for all database Archiving and Decommissioning activities in support of multiple clinical programs.

• Rendering of PDFs utilizing the approved tools via Electronic Data Capture for archiving data.

• Generation of Final Subject PDFs for site Archival package, and creation of the subjects needed for Item 12 submission requests.

• Decommissioning of trials from the production servers via AWS.

• Ensuring PDFs are filed in official repository (i.e., Veeva Vault) TMF.

Coordinates and participates in the following activities:

• Develop required training and provide ongoing training and development to Developers on standards and Study Build, transformations, mapping, reporting and Archival Process.

• Interfaces with functional manager to assure consistency of technical and process strategies across all therapy areas.

• Plans appropriately to ensure adherence to timelines.

• Acts as a technical resource to a functional group.

• Interface with members of study teams and key stakeholders, to integrate requirements into all deliverables.

• Ensures adherence to clinical database standards, SDTM structures, SOPs, and Process Guidelines.

• Trains new hires and participates in the interview process.

• Helps to develop a customer oriented and can-do attitude on a team and contributes as subject matter expert for trouble-shooting findings.

• Leads and participates in activities including, but not limited to, task forces, testing of new systems and helps coordinate technical initiatives.

• Contributes strategies, innovative and creative solutions to enhance processes and increase productivity of a group.

• Assist Manager/Associate Director in project planning, manpower projections and resource allocations across therapy areas.

B.A. or B.S. degree, preferably in mathematics, science, a healthcare-related discipline, or computer science; or relevant skills and experience.

• Knowledge of database structures and available tools to manage, extract, report, and warehouse data.

• Minimum 4 years of database development or data programming experience, at least three of which including clinical databases.

• Demonstrated strong technical proficiency in a Clinical Data Management Systems (i.e., InForm, Inform Architect, Central Designer, SQL-PL/SQL

• Minimum 4 years of experience with

  CDISC Standards, (SDTM, CDASH, Define.xml)

  XML, Java

  ELT tools

• 3+ years’ experience in data transformations and data loading in tools such as InForm

• 2+ years’ experience in System Development Lifecycle Management / system validation knowledge.

• 3+ years’ experience with reporting tools such as Cognos or JReview.

• Experience in eCRF generation for site documentation and downstream regulatory compliance deliverables.

• Advanced knowledge of the Data Management process from study start-up through close-out.

• Ability to collaborate and communicate with cross functional stakeholders to interpret and ensure quality report specifications and input to report development.

• Solid knowledge of MS Windows/Office software and exposure to web-based applications.

• Effective communication skills (oral and written) with the ability to communicate with both the technical and business areas.

• Strong organizational and critical thinking skills.

• Keen sense of urgency and customer focus.

• Ability to work cross functionally and as part of a team.

• Able to work independently, under pressure and change environment with flexibility.

• An overall working knowledge of drug discovery process, FDA regulations, GxP guidelines, ICH guidelines, clinical database validation and documentation processes, and 21 CFR Part 11.

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Description

Requirements

Bachelor's degree, preferably in IT, mathematics, science, a healthcare-related discipline, or computer science; or relevant skills and experience.

Languages:

• English business proficient

Skills

• Knowledge of database structures and available tools to manage, extract, report, and warehouse data.

• Desirable knowledge of database structures and available tools to manage, extract, report, and warehouse data (SQL-PL/SQL scripting).

• Desirable 4 years of database development or data programming experience, at least three of which including clinical databases.

• Desirable technical proficiency in a Clinical Data Management Systems (i.e., InForm, Inform Architect, Central Designer).

• Desirable 4 years of experience with CDISC Standards (if possible), (SDTM, CDASH, Define.xml), XML, Java, ELT tools

• 2+ years’ experience in System Development Lifecycle Management / system validation knowledge.

• Desirable experience with reporting tools such as SAS, Cognos or JReview.

• Desirable experience in eCRF generation for site documentation and downstream regulatory compliance deliverables.

• Ability to collaborate and communicate with cross functional stakeholders to interpret and ensure quality report specifications and input to report development.

• Solid knowledge of MS Windows/Office software and exposure to web-based applications.

• Effective communication skills (oral and written) with the ability to communicate with both the technical and business areas.

• Strong organizational and critical thinking skills.

• Keen sense of urgency and customer focus.

• Ability to work cross functionally and as part of a team.

• Able to work independently, under pressure and change environment with flexibility.

Activities may include, but are not limited to:

• Creates and develops clinical databases and data transfer files according to written specifications.

• Leads and participates in the review of electronic case report forms (eCRF) and edit checks, database development, programming of edit checks, and scripts to aid in transfer of electronic data files into the Clinical Data Management System (CDMS). 

• Interface with members of study teams, including external CROs/Vendors where applicable, to integrate study team requirements into all deliverables.

• Responsible for reporting deliverables supporting data cleaning and verification and any external data captured in clinical studies.

• Creates and reviews reporting specifications to ensure high quality deliverables, meet SDTM structure requirements and the needs of the business.

• Leads and participates in the review of standard and template reports, and scripts to aid in the review of data to ensure a quality database.

• Participate in database Archiving and Decommissioning activities in support of multiple clinical programs (with Vendors interaction).

Coordinates and/or participates in the following activities:

• Develop required training and provide ongoing training and development to Developers on standards and Study Build, transformations, mapping, reporting and Archival Process.

• Interfaces with functional manager to assure consistency of technical and process strategies across all therapy areas.

• Plans appropriately to ensure adherence to timelines.

• Acts as a technical resource to a functional group.

• Interface with members of study teams and key stakeholders, to integrate requirements into all deliverables.

• Ensures adherence to clinical database standards, SDTM structures, SOPs, and Process Guidelines.

• Trains new hires and participates in the interview process.

• Helps to develop a customer oriented and can-do attitude on a team and contributes as subject matter expert for trouble-shooting findings.

• Leads and/or participates in activities including, but not limited to, task forces, testing of new systems and helps coordinate technical initiatives.

• Contributes strategies, innovative and creative solutions to enhance processes and increase productivity of a group.

• Assist Manager/Associate Director in project planning, manpower projections and resource allocations across therapy areas.

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):