Associate Clinical Research Manager

MSD; Petaling Jaya; On-site; 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

Job Description

This role is primarily responsible for the end-to-end performance and project management of assigned clinical study protocols within a country, ensuring compliance with ICH/GCP guidelines, local regulations, company policies and procedures, quality standards, and adverse event reporting requirements.

The aCRM may be responsible for managing a specific study across multiple countries, including Malaysia, Singapore, and/or Indonesia.

Key Responsibilities

• Serve as the primary point of contact (POC) for assigned protocols and act as the liaison 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 & Competencies

• Strong knowledge of project management and/or site management.
• Excellent organizational and prioritization skills.
• Ability to work independently and make informed decisions within established policies and guidelines.
• Strong understanding of the local regulatory environment.
• Scientific and clinical research knowledge.
• Understanding of clinical trial planning, management, and performance metrics.
• Ability to manage multiple studies and competing priorities simultaneously.
• Strong stakeholder management and collaboration skills.
• Effective communication skills in both written and spoken English and the local language.
• Strategic thinking and problem-solving capability.
• Ability to work effectively in remote and virtual environments.
• Emerging leadership capabilities with the ability to influence and align stakeholders.
• Proactive identification of risks, issues, and opportunities, with the ability to develop mitigation plans.
• Strong negotiation and conflict-resolution skills.
• Excellent diplomacy, relationship-building, and interpersonal skills.
• AI fluency.

Qualifications & Experience

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

Travel Requirement: Up to 30% travel required.

Required Skills

• Adaptability
• Adaptability
• Clinical Research
• Clinical Site Management
• Clinical Trial Agreements (CTA)
• Clinical Trial Compliance
• Clinical Trial Documentation
• Clinical Trial Management
• Clinical Trial Planning
• Clinical Trials Monitoring
• Clinical Trials Operations
• Conflict Management
• Cross-Cultural Awareness
• ICH GCP Guidelines
• Knowledge Management
• Negotiation
• Organizational Leadership
• Outsourcing
• Patient Recruitment
• Process Management
• Project Delivery
• Project Development
• Project Management Methodology (PMM)
• Project Planning
• Project Scoping
• {+ 7 more}

Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 11/30/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.