Clinical Research Manager (CRM) - Immunology (REMOTE)

Merck KGaA Darmstadt Germany - Trenton, NJ

Full-time - Mid Level

Remote - Trenton, NJ

Chemical Manufacturing

About the position

The Clinical Research Manager (CRM) - Immunology position at Merck is a remote role primarily responsible for the end-to-end performance and project management of assigned clinical trial protocols across various countries. This role requires compliance with ICH/GCP guidelines, country regulations, and Merck's internal policies and procedures. The CRM will serve as the main point of contact for assigned protocols, acting as a liaison between Country Operations and the Clinical Trial Team (CTT). The CRM is accountable for the performance of assigned studies, ensuring that all deliverables, timelines, and results meet the commitments made to the countries involved in the trials. In this role, the CRM will proactively plan, drive, and track the execution of studies from feasibility and site selection through recruitment, execution, and closeout. The CRM will review monitoring visit reports, escalate performance issues, and conduct quality control visits as necessary. Leading local study teams to achieve high performance is a key responsibility, which includes training local roles in the protocol and closely collaborating with Clinical Research Associates (CRAs) to ensure strong coordination across various local country roles. The CRM will also be responsible for creating and executing a local risk management plan for assigned studies, ensuring compliance with key systems such as CTMS and eTMF. The role involves identifying and sharing best practices across clinical trials and countries, collaborating with functional outsourcing vendors, investigators, and other external partners. As a customer-facing role, the CRM will build business relationships and represent Merck with investigators, supporting local and regional strategy development in alignment with long-term corporate needs. The CRM will also collaborate with various internal functions to align on key issues and decisions across trials, consulting with Global Health and Human Services (GHH) as needed.

Responsibilities

• Serve 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, ensuring timelines and deliverables are met.
• Accountable for performance compliance with ICH/GCP and country regulations.
• Review monitoring visit reports and escalate performance issues as needed.
• Conduct quality control visits as required.
• Lead local study teams, providing training and support as the protocol expert.
• Create and execute local risk management plans for assigned studies.
• Ensure compliance with CTMS, eTMF, and other key systems.
• Identify and share best practices across clinical trials and countries.
• Collaborate with functional outsourcing vendors and external partners.
• Build business relationships and represent Merck with investigators.
• Support local and regional strategy development in conjunction with CRD, TAH, and Regional Operations.
• Collaborate with internal HQ functions and regional/local operations to align on key issues.

Requirements

• Strong knowledge in project management and site management.
• Demonstrated strong organizational skills and ability to make independent decisions.
• Understanding of local regulatory environments and clinical research knowledge.
• Experience in clinical trial planning, management, and metrics.
• Ability to manage multiple deliverables and protocols simultaneously.
• Effective communication skills in a remote/virtual environment.
• Proficiency in written and spoken English and local language.

Nice-to-haves

• Experience functioning as a key link between Country Operations and Clinical Trial Teams.
• Strong scientific and clinical research knowledge.

Benefits

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