Merck KGaA Darmstadt Germany - Santa Fe, NM

posted 6 days ago

Full-time - Mid Level
Remote - Santa Fe, NM
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 assigned clinical trial protocols. This remote position requires compliance with ICH/GCP and local regulations, ensuring quality standards and effective communication between country operations and clinical trial teams. The CRM will lead local study teams, manage project timelines, and collaborate with various stakeholders to drive successful trial execution.

Responsibilities

  • Serve as the main point of contact for assigned protocols and link between Country Operations and clinical trial team (CTT).
  • 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.
  • Perform 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 CTMS, eTMF, and other key systems in assigned studies.
  • Identify and share best practices across clinical trials and countries.
  • Collaborate with functional outsourcing vendors and external partners in assigned studies.
  • Support local and regional strategy development in conjunction with CRD and Regional Operations.

Requirements

  • 5 years of experience in clinical research.
  • CRA experience preferred.
  • Trial management experience preferred.
  • Bachelor's degree in Science or comparable field.

Nice-to-haves

  • Advanced degree (e.g., Master's degree, MD, PhD).
  • 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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