Associate Clinical Research Manager

Merck Gruppe - MSD Sharp & Dohme; Petaling Jaya; Hybrid; MYR 120.000 - 170.000; Vollzeit

Benefits dieser Stelle

Hybrid work model

Zusammenfassung

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.

Qualifikationen

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

Aufgaben

• 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.

Kenntnisse

Project management

Clinical trial management

Stakeholder management

English communication

Regulatory knowledge

Cross-cultural awareness

ICH GCP guidelines

Ausbildung

Bachelor's Degree in Science or related discipline

Jobbeschreibung

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 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 & 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 ManagementProject Delivery
• Project Development
• Project Management Methodology (PMM)
• Project Planning
• Project Scoping
• {+ 7 more}

Employee Status

Regular

Flexible Work Arrangements

Hybrid

Job Posting End Date: 11/30/2026

Requisition ID:R420996

*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.