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

Merck KGaA Darmstadt Germany - Boise, ID

Full-time - Mid Level

Remote - Boise, ID

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 the clinical trial team. The CRM plays a critical role in planning, executing, and closing out studies, ensuring high performance and adherence to quality standards.

Responsibilities

• Serve as the main point of contact for assigned protocols and link between Country Operations and the clinical trial team (CTT).
• Manage project timelines and deliverables for assigned studies, ensuring commitments are met from feasibility to close out.
• Ensure compliance with ICH/GCP, company policies, and quality standards for assigned protocols.
• Review monitoring visit reports and escalate performance issues to CRA manager and internal management as needed.
• Perform quality control visits as required.
• Lead local study teams, providing training and support to local roles and ensuring collaboration among team members.
• Create and execute local risk management plans for assigned studies.
• Ensure compliance with CTMS, eTMF, and other key systems in assigned studies.
• Escalate challenges and issues to TA Head/CRD/CCQM or CTT as appropriate.
• Identify and share best practices across clinical trials and countries.
• Collaborate with functional outsourcing vendors, investigators, and other external partners in assigned studies.
• Act as the country point of contact for programmatically outsourced trials for assigned protocols.
• Build business relationships and represent the Manufacturing Division with investigators.
• Support local and regional strategy development in conjunction with CRD and Regional Operations.

Requirements

• Proven experience in clinical research project management, particularly in infectious diseases.
• Strong knowledge of ICH/GCP guidelines and local regulations.
• Excellent communication and interpersonal skills to manage relationships with various stakeholders.
• Ability to lead and train local study teams effectively.
• Experience in risk management and quality control in clinical trials.

Nice-to-haves

• Experience with programmatically outsourced trials.
• Familiarity with CTMS and eTMF systems.
• Previous experience in a customer-facing role within the clinical research field.

Benefits

• Health insurance coverage
• 401k retirement savings plan
• Paid holidays
• Flexible scheduling options
• Professional development opportunities