About the role
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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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
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