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 escalate 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:

Preferred Skills:

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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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

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Requisition ID:R420996

Job Requirements