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Associate Clinical Research Manager

msd · MYS - Selangor - Petaling Jaya (Ascent Paradigm)

New
Hybrid Mid 🇬🇧 English
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

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

Questions fréquentes

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Source : ats:workday

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Published 2 hours ago

Expires 1 month from now

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msd

MYS - Selangor - Petaling Jaya (Ascent Paradigm)