Total 7 Project Manager job vacancies in Education / Training category in Malaysia

Job Description

Main Responsibility

• The clinical research physician is expected to abstract high level relevant clinical and preclinical data and effectively use these data in supporting China registration.  The clinical research physician is expected to address issues/questions raised.
• Whenever Clinical Research designs a clinical study, the clinical research physician (clinical monitor) is expected to drive study design, and collaborate with biostatisticians, regulatory affairs, and other relevant disciplines to construct a high quality clinical study protocol.  
• The clinical research physician will also work as clinical scientist, to lead lab selection and clinical supply application during study planning phase, provide scientific inputs, and review protocol deviation and answer protocol related questions during study implementation phase.
• To develop the best, most suitable clinical plan and protocol, the clinical research physician is expected to engage scientific leaders and internal key stakeholders such as medical affair, and marketing and regulatory affair.
• The clinical research physician will participate due diligence evaluation as expert for medical related matter. Clinical physician is also working closely with medical affair to identify gap/opportunities of patient care in China and develop clinical plan/study to capitalize the emerging opportunities.

Requirements

• Master Degree and above in clinical medicine (at least 5 year medical school graduates)
• Deep understanding of China regulatory environment and clinical development procedure.
• Previous experience of clinical research/clinical development is highly desirable.
• Be bright, driven, dedicated, persistent, strategic, flexible, clever, and resourceful. 
• The candidate should have a strong leadership, excellent written and oral communication skills, and project management skills.
• Strong capability of work prioritization and deliver results with parallel multiple tasks.
• Excellent language skills in both English and Chinese (fluent in verbal and written).

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:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Description

Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.

WHAT YOU WILL DO

This role is primarily accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, our policies and procedures, quality standards and adverse event reporting requirements internally and externally. The CRM could be responsible for a particular study for several countries in a cluster.

Responsibilities include, but are not limited to:

• Main Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).

• Responsible for project management of the assigned studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out.

• Accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our policies and procedures, quality standards and adverse event reporting requirements internally and externally.

• Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed. o Performs Quality control visits as required.

• Leads local study teams to high performance: trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration (including the CTC, CRAs and COM).

• Responsible for creating and executing a local risk management plan for assigned studies.

• Ensures compliance with CTMS, eTMF and other key systems in assigned studies.

• Escalates as needed different challenges and issues to TA Head/CRD/CCQM and or CTT (as appropriate).

• Identifies and shares best practices across clinical trials, countries, clusters.

• Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies.

• Country POC for programmatically outsourced trials for assigned protocols.

• In this position, you will be responsible for building business relationships and representing our company to investigators as a customer-facing role.

• Serves local business needs as applicable in their country (if delegated can sign contracts and manage budgets).

• Supports local and regional strategy development consistent with long‐term corporate needs in conjunction with CRD, TAH and Regional Operations.

• Collaborates internally with HQ functions, regional and local operations, EU Clinical Development, Pharmacovigilance, Global Medical Affairs to align on key issues/decisions across the trials. Consult with GHH as needed.

CORE Competency Expectations:

• Knowledge in Project Management and site management.

• Strong organizational skills with demonstrated success required.

• 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 or CRD.

• Requires strong understanding of local regulatory environment.

• Strong scientific and clinical research knowledge is required.

• Strong understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously.

• Experience functioning as a key link between Country Operations and Clinical Trial Teams

• Communicates effectively and builds a collaboration spirit in a remote/virtual environment and across countries, cultures and functions.

• Ability and skills to manage resource allocation, processes (and controls), productivity, quality and project delivery.

• Proficiency in written and spoken English and local language. The incumbent must be competent and effective in written and verbal communication.

• Strategic thinking.

• Ability to work efficiently in a remote and virtual environment.

• Understand cultural diversity.

• The position requires proven strong project management skills and/or project management certification or relevant training program/close mentoring.

Behavioral Competency Expectations:

• Strong leadership skills that enable and drive alignment with the goals, purpose and mission of our Research Labs (MRL), Global Clinical Development (GCD) and GCTO.

• Ability to identify problems, conflicts and opportunities early and lead, analyze and prepare mitigation plans and drive conflict resolution is critical.

• Required to negotiate skillfully in tough situations with both internal and external groups; settle differences with minimum disruption. Examples of common problems include: 1) low patient recruitment, 2) inadequate staff to meet business needs, 3) performance or compliance issues, 4) working with regulatory issues and the broader organization, and 5) resolution of conflictive situations.

• Educational/pedagogic, diplomatic and empathic skills to effectively build and maintain professional relationships with investigators and other stakeholders.

Experience Requirements:

• Required: • At least 9 years of clinical research experience, including at least 2 years of project or people management and 5 years of monitoring experience.​

​

​Educational Requirements:

• Required: • Bachelor degree in Science (or comparable)

• Preferred: • Advanced degree, (e.g., Master degree, MD, PhD).

Who we are

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

 

What we look for

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

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:

Regular

Relocation:

Domestic

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Description

Main Responsibility

• The clinical research physician is expected to abstract high level relevant clinical and preclinical data and effectively use these data in supporting China registration.  The clinical research physician is expected to address issues/questions raised.
• Whenever Clinical Research designs a clinical study, the clinical research physician (clinical monitor) is expected to drive study design, and collaborate with biostatisticians, regulatory affairs, and other relevant disciplines to construct a high quality clinical study protocol.  
• The clinical research physician will also work as clinical scientist, to lead lab selection and clinical supply application during study planning phase, provide scientific inputs, and review protocol deviation and answer protocol related questions during study implementation phase.
• To develop the best, most suitable clinical plan and protocol, the clinical research physician is expected to engage scientific leaders and internal key stakeholders such as medical affair, and marketing and regulatory affair.
• The clinical research physician will participate due diligence evaluation as expert for medical related matter. Clinical physician is also working closely with medical affair to identify gap/opportunities of patient care in China and develop clinical plan/study to capitalize the emerging opportunities.

Requirements

• Master Degree and above in clinical medicine (at least 5 year medical school graduates)
• Deep understanding of China regulatory environment and clinical development procedure.
• Previous experience of clinical research/clinical development is highly desirable.
• Be bright, driven, dedicated, persistent, strategic, flexible, clever, and resourceful. 
• The candidate should have a strong leadership, excellent written and oral communication skills, and project management skills.
• Strong capability of work prioritization and deliver results with parallel multiple tasks.
• Excellent language skills in both English and Chinese (fluent in verbal and written).

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:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Description

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:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Description

Position Overview

China Development Center seeks individuals to provide leadership and experience in conducting clinical research in China. One of the most important mission of clinical research in China is to shorten gap of the drug lag in China so effective treatment options become available to Chinese patients. This individual will be the key driver of assigned program(s) for developing local registration strategy, engaging key opinion leaders, developing study protocol, drafting study report, and preparing dossier for regulatory submission.

Main Responsibility

• This individual will serve as the key interface between headquarter project development team and China development center. The clinical research physician is expected to abstract high level relevant clinical and preclinical data and effectively use these data in supporting China registration.  
• Whenever Clinical Research designs a clinical study, the clinical research physician (clinical monitor) is expected to drive study design, and collaborate with biostatisticians, regulatory affairs, and other relevant disciplines to construct a high quality clinical study protocol.
• The clinical research physician will also work as clinical scientist, to lead lab selection and clinical supply application during study planning phase, provide scientific inputs and investigator meeting during study initiation phase, and review protocol deviation and answer protocol related questions during study implementation phase.
• To develop the best, most suitable clinical plan and protocol, the clinical research physician is expected to engage scientific leaders and internal key stakeholders such as medical affair, and marketing and regulatory affair. The clinical physician will be involving in introducing new compounds in development to China scientific leaders and seek feedback for our clinical development plan as needed.
• The clinical research physician will participate due diligence evaluation as expert for medical related matter. Clinical physician is also working closely with medical affair to identify gap/opportunities of patient care in China and develop clinical plan/study to capitalize the emerging opportunities.

Requirements

• Master or above degree in clinical medicine (at least 5 year medical school graduates)
• Deep understanding of China regulatory environment and clinical development procedure.
• Previous experience of clinical research/clinical development is highly desirable,
• Be bright, driven, dedicated, persistent, strategic, flexible, clever, and resourceful. 
• have a strong leadership, excellent written and oral communication skills, and project management skills.
• Strong capability of work prioritization and deliver results with parallel multiple tasks.
• Excellent language skills in both English and Chinese (fluent in verbal and written).
• The position may require the flexibility to work outside of the area of primary medical specialization.   

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:

Regular

Relocation:

No relocation

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Description

We know that our people are the key to our success, which is why our Human Resources team works to attract, develop, retain and inspire our people so that they can learn, grow and make a true impact on the world. Together we collaborate to create a culturally rich, diverse organization ensuring we remain innovative and agile.

In the role as Learning Manager (m/f/d) you execute, drive and manage employee upskilling training plans, concepts, and sessions of our company in Germany. You will ensure an efficient and worthwhile training experience for our employees (e.g. format, content, methodology, applied technology, stakeholder involvement), continuously optimize the quality of upskilling processes, as well as enable all employees to adopt  the latest scientific outcomes and learning trends. You will support our employees to embrace the spirit of learning, enabling them to learn from and teach each other playing an integral role within our comapny to ultimately become a learning organization.

As  Learning Manager you are reporting directly into the Strategy Office Learning Lead and are jointly managing the diverse and complex challenges of fast changing product and capability requirements for our employees working closely with the Learning Team.

Role Responsibilities:

We are looking for a team player, a genuine people developer and a trainer with a hands-on attitude and execution drive.

• You have a strong passion about people development, innovative employee upskilling, pharma product updates as well as learning culture.

• You will be responsible to evolve the learning experience in our oncology business unit through understanding key trends and challenges of our employees with a key focus on standardizing the onboarding experience within our oncology business unit.

• You will design and implement comprehensive solutions for product training and onboarding together with your internal stakeholders and subject matter experts.

• You thrive working at the interface of our people and the business, love solving challenges together in a crossfunctional team. You are comfortable to experiment and are able to translate those learnings into a long-term vision and strategy for our Strategy Office and the organization.

Qualifications, Skills & Experience:

• Bachelor’s Degree required

• Learning & Development background including training experience

• Scientific Knowledge about pharmaceuticals especially in the field of immuno-oncology through formal education and/or work experience

• Proven track record of designing and executing employee upskilling sessions and implementation of high-quality training concepts and strategies that support our vision of a learning organization

• Excellent teaching, coaching, communication, and collaboration skills, in both larger groups and in individual 1:1 sessions

• Embrace a positive & constructive feedback culture

• Team player

• Experience in working in a cross-functional and cross-cultural setup

• Ability to triangulate, simplify and translate complex scientific topics and latest product/ service updates into clear training contents

• Strong project management skills

• Expertise in building tailored learning strategies and translating them into a roadmap

• Resourcefulness,  innovative, outside-the-box and long-term thinking

• High innovation & technology affinity required to develop a seamless and superior employee upskilling experience

• Fluency in German & English is required

Our Support Functions deliver services and make recommendations about ways to enhance our workplace and the culture of our organization. Our Support Functions include HR, Finance, Information Technology, Legal, Procurement, Administration, Facilities and Security.

People with severe disabilities and their equivalents will be given preference if they are equally qualified.

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:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Remote

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

No

Job Description

Main Responsibility

• The clinical research physician is expected to abstract high level relevant clinical and preclinical data and effectively use these data in supporting China registration.  The clinical research physician is expected to address issues/questions raised.
• Whenever Clinical Research designs a clinical study, the clinical research physician (clinical monitor) is expected to drive study design, and collaborate with biostatisticians, regulatory affairs, and other relevant disciplines to construct a high quality clinical study protocol.  
• The clinical research physician will also work as clinical scientist, to lead lab selection and clinical supply application during study planning phase, provide scientific inputs, and review protocol deviation and answer protocol related questions during study implementation phase.
• To develop the best, most suitable clinical plan and protocol, the clinical research physician is expected to engage scientific leaders and internal key stakeholders such as medical affair, and marketing and regulatory affair.
• The clinical research physician will participate due diligence evaluation as expert for medical related matter. Clinical physician is also working closely with medical affair to identify gap/opportunities of patient care in China and develop clinical plan/study to capitalize the emerging opportunities.

Requirements

• Master Degree and above in clinical medicine (at least 5 year medical school graduates)
• Deep understanding of China regulatory environment and clinical development procedure.
• Previous experience of clinical research/clinical development is highly desirable.
• Be bright, driven, dedicated, persistent, strategic, flexible, clever, and resourceful. 
• The candidate should have a strong leadership, excellent written and oral communication skills, and project management skills.
• Strong capability of work prioritization and deliver results with parallel multiple tasks.
• Excellent language skills in both English and Chinese (fluent in verbal and written).

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:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):