Clinical Study Project Lead - Hybrid (Country Ops)

MSD; Petaling Jaya; Hybrid; MYR 140,000 - 220,000; Full time

Job summary

MSD Malaysia seeks an experienced Country Operations professional to lead end-to-end performance and project management of assigned clinical study protocols in Malaysia and across nearby countries. You will ensure ICH/GCP compliance, regulatory adherence, and quality standards while coordinating with the Clinical Trial Team and country functions.

You will mentor local teams, manage risks, and drive collaboration with vendors, investigators, and external partners in a hybrid work setup.

Qualifications

• Bachelor's Degree in Science or related discipline.
• Minimum 4 years of experience in clinical research.
• CRA experience preferred.

Responsibilities

• Serve as the primary 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 elevate 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

Site management

Communication skills

Regulatory knowledge

Remote collaboration

AI fluency

Education

Bachelor's Degree in Science or related discipline

Job description

MSD Malaysia seeks an experienced Country Operations professional to lead end-to-end performance and project management of assigned clinical study protocols in Malaysia and across nearby countries. You will ensure ICH/GCP compliance, regulatory adherence, and quality standards while coordinating with the Clinical Trial Team and country functions.

You will mentor local teams, manage risks, and drive collaboration with vendors, investigators, and external partners in a hybrid work setup.