Associate Clinical Research Manager
msd · MYS - Selangor - Petaling Jaya (Ascent Paradigm)
Job description
About the role
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.
Key responsibilities
- Serve as primary point of contact for assigned protocols and liaise between Country Operations and the Clinical Trial Team.
- Oversee project management activities from feasibility through closeout, including planning, execution, tracking deliverables and timelines.
- Ensure protocol performance and compliance with regulations, policies, procedures and quality standards.
- Review Monitoring Visit Reports, conduct Quality Control Visits and escalate issues as needed.
- Lead local study teams, develop risk management plans and manage relationships with investigators and external partners.
Required profile
- Strong knowledge of project and site management in clinical research.
- Excellent organizational, prioritization and stakeholder management skills.
- Ability to work independently, make decisions within policies and manage multiple studies simultaneously.
- Understanding of local regulatory environment and clinical trial performance metrics.
- Effective communication in English and the local language, with strategic thinking and problem‑solving capability.
Required skills
- Clinical Research
- Clinical Site Management
- Clinical Trial Agreements (CTA)
- Clinical Trial Compliance
- Clinical Trial Documentation
- Clinical Trial Management
- Clinical Trial Planning
- Clinical Trials Monitoring
- ICH GCP Guidelines
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Published 2 hours ago
Expires 1 month from now
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msd
MYS - Selangor - Petaling Jaya (Ascent Paradigm)
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