Associate Clinical Research Manager

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.