Clinical Research Manager (CRM) - Infectious Disease (REMOTE)

Merck KGaA Darmstadt Germany - Augusta, ME

Full-time - Mid Level

Remote - Augusta, ME

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 in compliance with regulatory standards and company policies. This remote position serves as the main point of contact for assigned protocols, ensuring effective collaboration between country operations and clinical trial teams. The CRM will manage multiple studies across various countries, focusing on project execution, compliance, and performance management.

Responsibilities

• Act as the main point of contact for assigned protocols and link between Country Operations and clinical trial team (CTT).
• Manage project execution for assigned studies, including planning, tracking deliverables, and meeting country commitments.
• Ensure compliance with ICH/GCP, country regulations, and company policies for assigned protocols.
• 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 for assigned studies.

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

Nice-to-haves

• Experience in Immunology or Infectious Diseases, specifically in the HIV therapeutic area.

Benefits

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