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:
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}
Preferred Skills:
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Search Firm Representatives Please Read Carefully
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:
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.
