Remote Clinical Research Program Manager

Merck

Atlanta (GA)

À distance

USD 142 000 - 224 000

Plein temps

Il y a 4 jours
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Résumé du poste

Merck is seeking a Clinical Research Manager to lead end-to-end protocol execution and oversee country operations in alignment with ICH-GCP and local regulations. You will coordinate with CROs, investigators, and internal teams to ensure timely delivery from feasibility to closeout.

The role emphasizes strong leadership, risk management, and cross-functional collaboration across remote teams, with a focus on quality and patient safety. Remote work is supported.

Qualifications

  • 5+ years of experience in clinical research.
  • Bachelor’s degree in science (or comparable)

Responsabilités

  • Main POC for assigned protocols and links between Country Operations and clinical trial team (CTT).
  • Project management of the assigned studies: plan, drive, and track execution to meet country commitments.
  • Ensure compliance with ICH/GCP and country regulations, company policies, quality standards, and adverse event reporting requirements.
  • Reviews Monitoring Visit Reports and escalates issues to CRA manager or vendors as needed.
  • Performs Quality control visits as required.
  • Leads local study teams to high performance and coordinates activities across local country roles.
  • Creates and executes local risk management plans for assigned studies.
  • Ensures compliance with CTMS, eTMF, and other key systems in assigned studies.
  • Collaborates with HQ and PV/Regulatory/GMA teams to align on decisions.
  • Represents the company with investigators as a customer-facing role.
  • Shares protocol-specific information and best practices across countries.

Connaissances

Clinical Trial Planning
Clinical Trials Operations
ICH GCP Guidelines
Regulatory Compliance
Risk Management
Team Leadership
Strategic Planning
Clinical Quality Management
Clinical Trials Monitoring
Training and Development
Strategic Thinking

Formation

Bachelor’s degree in science (or comparable)
Advanced degree (e.g., Master degree, MD, PhD)

Description du poste

Merck is seeking a Clinical Research Manager to lead end-to-end protocol execution and oversee country operations in alignment with ICH-GCP and local regulations. You will coordinate with CROs, investigators, and internal teams to ensure timely delivery from feasibility to closeout.

The role emphasizes strong leadership, risk management, and cross-functional collaboration across remote teams, with a focus on quality and patient safety. Remote work is supported.

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