Remote Clinical Research Lead — Global Trials & Compliance

Merck

Montpelier (VT)

A distancia

USD 142.000 - 224.000

Jornada completa

Hace 4 días
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Descripción de la vacante

Merck in the United States is seeking a Clinical Research Manager to lead end-to-end study performance and project management for assigned protocols. You will ensure adherence to ICH/GCP and country regulations, coordinate with country operations and trial teams, and manage relationships with investigators and vendors.

The role emphasizes strong leadership, risk management, and collaboration across clinical operations, pharmacovigilance, regulatory, and medical affairs to drive high-quality

Formación

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

Responsabilidades

  • Main POC for assigned protocols and links between Country Operations and clinical trial team (CTT).
  • Pro-actively plans, drives, and tracks execution and performance of deliverables to meet country commitments.
  • Accountable for protocol performance in a country in compliance with ICH/GCP and local regulations.
  • 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, trains local roles, and coordinates across country roles.
  • Creates and executes a local risk management plan for assigned studies.
  • Ensures compliance with CTMS, eTMF, and other systems in studies.
  • Escalates challenges to TA Head/ CRD or CTT as appropriate.
  • Collaborates with outsourcing vendors, investigators, and external partners.

Conocimientos

Project management
Leadership
Regulatory knowledge
English communication
Strategic thinking

Educación

Bachelor’s degree in science
Advanced degree (Master/MD/PhD)

Descripción del empleo

Merck in the United States is seeking a Clinical Research Manager to lead end-to-end study performance and project management for assigned protocols. You will ensure adherence to ICH/GCP and country regulations, coordinate with country operations and trial teams, and manage relationships with investigators and vendors.

The role emphasizes strong leadership, risk management, and collaboration across clinical operations, pharmacovigilance, regulatory, and medical affairs to drive high-quality

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