Global Clinical Study Manager - Hybrid

Merck Gruppe - MSD Sharp & Dohme; Petaling Jaya; Hybrid; MYR 120,000 - 170,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

Merck Gruppe - MSD Sharp & Dohme is seeking an experienced Clinical Study Project Manager to oversee end-to-end performance of assigned protocols in Malaysia, ensuring ICH/GCP compliance and local regulations.

The role requires coordinating with the Clinical Trial Team, country operations, and vendors, while managing risks, overseeing CTMS/eTMF, and driving study performance from feasibility to closeout.

Qualifications

• Bachelor's Degree in Science or a related discipline.
• Minimum 4 years of experience in clinical research.
• Clinical Research Associate (CRA) experience preferred.

Responsibilities

• Serve as the primary point of contact (POC) for assigned protocols and liaise between Country Operations and the Clinical Trial Team (CTT).
• Oversee project management activities for assigned studies, including planning, execution, tracking deliverables, timelines, and study performance from feasibility through closeout.
• Ensure protocol performance and compliance with applicable regulations, policies, procedures, and quality standards.
• Review Monitoring Visit Reports (MVRs) and expedite performance issues or training needs when required.
• Conduct Quality Control Visits (QCVs) as needed.
• Lead and support local study teams by providing protocol expertise, training, and coordination across country functions, including Clinical Trial Coordinators (CTCs), Clinical Research Associates (CRAs), and Clinical Operations Managers (COMs).
• Develop and execute local risk management plans for assigned studies.
• Ensure compliance with CTMS, eTMF, and other key clinical systems.
• Escalate study-related challenges and risks to appropriate stakeholders as needed.
• Identify and share best practices across studies, countries, and regional teams.
• Collaborate with outsourcing vendors, investigators, and external partners.
• Serve as the country contact for programmatically outsourced trials.
• Build and maintain strong relationships with investigators and external stakeholders.
• Support local business needs, including contract and budget management where delegated.
• Contribute to local and regional strategy development.
• Partner with global, regional, and local stakeholders including Clinical Operations, Pharmacovigilance, and Medical Affairs to drive study success.

Skills

Project management

Clinical trial management

Stakeholder management

English communication

Regulatory knowledge

Cross-cultural awareness

ICH GCP guidelines

Education

Bachelor's Degree in Science or related discipline

Job description

Merck Gruppe - MSD Sharp & Dohme is seeking an experienced Clinical Study Project Manager to oversee end-to-end performance of assigned protocols in Malaysia, ensuring ICH/GCP compliance and local regulations.

The role requires coordinating with the Clinical Trial Team, country operations, and vendors, while managing risks, overseeing CTMS/eTMF, and driving study performance from feasibility to closeout.