Merck KGaA Darmstadt Germany - Providence, RI

posted 6 days ago

Full-time - Mid Level
Remote - Providence, RI
Chemical Manufacturing

About the position

The Clinical Research Manager (CRM) for Infectious Disease at Merck is responsible for overseeing the end-to-end performance and project management of clinical trials across multiple countries. This role ensures compliance with ICH/GCP guidelines and local regulations while managing relationships between country operations and clinical trial teams. The CRM will lead local study teams, manage project timelines, and ensure quality standards are met throughout the clinical trial process.

Responsibilities

  • Serve as the main point of contact for assigned protocols and link between Country Operations and the clinical trial team.
  • Manage project timelines and performance for assigned studies, ensuring compliance with regulations and company policies.
  • Review monitoring visit reports and escalate performance issues as needed.
  • Conduct quality control visits as required.
  • Lead local study teams, providing training and support to ensure high performance.
  • Create and execute local risk management plans for assigned studies.
  • Ensure compliance with key systems such as CTMS and eTMF.
  • Identify and share best practices across clinical trials and countries.
  • Collaborate with functional outsourcing vendors and external partners for assigned studies.
  • Support local and regional strategy development in conjunction with CRD and Regional Operations.

Requirements

  • 5 years of experience in clinical research.
  • Preferred experience as a Clinical Research Associate (CRA).
  • Trial management experience is preferred.
  • Bachelor's degree in Science or a comparable field.

Nice-to-haves

  • Advanced degree (e.g., Master's, MD, PhD) preferred.
  • Experience in Immunology or Infectious Diseases, specifically in the HIV therapeutic area.

Benefits

  • Health insurance
  • 401k plan
  • Paid holidays
  • Flexible scheduling
  • Professional development opportunities
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