Remote Clinical Research Manager - Trials & Compliance

Merck

Austin (TX)

Remote

USD 142,000 - 224,000

Full time

4 days ago
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Job summary

Merck in the United States is seeking a Clinical Research Manager to lead end-to-end performance and project management for assigned protocols in compliance with ICH/GCP and country regulations. He/she will act as POC between Country Operations and the clinical trial team, coordinating feasibility, site selection, recruitment, and study execution across countries as needed.

The role requires strong leadership, strategic thinking, and excellent English communication, with a remote work option and

Qualifications

  • 5+ years of experience in clinical research.
  • Bachelor's degree in science required.
  • Advanced degree preferred (e.g., MS, MD, PhD).
  • CRA experience and Oncology exposure preferred.
  • Study management experience is a plus.

Responsibilities

  • Main Point of Contact (POC) for assigned protocols and links between Country Operations and clinical trial team (CTT).
  • Responsible for project management of the assigned studies: plans, drives, and tracks execution and performance to meet country commitments.
  • Accountable for performance for assigned protocols in a country per ICH/GCP and local regulations.
  • Reviews Monitoring Visits Reports and escalates performance issues as needed.
  • Performs Quality control visits as required.
  • Leads local study teams to high performance and coordinates activities across local country roles.
  • Responsible for creating and executing a local risk management plan for assigned studies.
  • Ensures compliance with CTMS, eTMF, and other key systems in assigned studies.

Skills

Project Management
Site Management
Regulatory Knowledge
Clinical Research
Clinical Trial Planning
Clinical Trial Management
Leadership
Communication Skills
Risk Management

Education

Bachelor’s degree in science
Advanced degree preferred

Tools

CTMS
eTMF

Job description

Merck in the United States is seeking a Clinical Research Manager to lead end-to-end performance and project management for assigned protocols in compliance with ICH/GCP and country regulations. He/she will act as POC between Country Operations and the clinical trial team, coordinating feasibility, site selection, recruitment, and study execution across countries as needed.

The role requires strong leadership, strategic thinking, and excellent English communication, with a remote work option and

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