Clinical Research Manager (CRM) - Immunology (REMOTE)

Merck KGaA Darmstadt Germany - Dover, DE

Full-time - Mid Level

Remote - Dover, DE

Chemical Manufacturing

About the position

The Clinical Research Manager (CRM) for Immunology at Merck is a pivotal role responsible for overseeing the end-to-end performance and project management of assigned clinical research protocols. This position is primarily remote and requires compliance with ICH/GCP guidelines, country regulations, and the company'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). This role is crucial in ensuring that clinical trials are executed efficiently and effectively, meeting all commitments from feasibility and site selection through to recruitment, execution, and closeout. In this role, the CRM will be accountable for the performance of assigned protocols within a specific country, ensuring adherence to quality standards and adverse event reporting requirements. Responsibilities include reviewing monitoring visit reports, performing quality control visits, and leading local study teams to achieve high performance. The CRM will also be responsible for creating and executing local risk management plans, ensuring compliance with key systems such as CTMS and eTMF, and escalating challenges to the appropriate stakeholders as needed. The CRM will collaborate with functional outsourcing vendors, investigators, and other external partners, serving as the country point of contact for programmatically outsourced trials. This position requires strong project management skills, the ability to communicate effectively in a remote environment, and a deep understanding of the local regulatory landscape. The CRM will also support local and regional strategy development in alignment with long-term corporate needs, working closely with various internal functions to ensure alignment on key issues and decisions across trials.

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 compliance with ICH/GCP and country regulations, as well as company policies and procedures.
• Review monitoring visit reports and escalate performance issues as needed.
• Perform 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 for assigned studies.

Requirements

• Bachelor's degree in Science or a comparable field is required.
• Minimum of 5 years of experience in clinical research is required.
• CRA experience is preferred.
• Strong understanding of local regulatory environment is essential.
• Proficiency in written and spoken English and local language is required.
• Strong organizational skills and ability to manage multiple deliverables simultaneously.
• Experience in project management and site management is required.
• Strong scientific and clinical research knowledge is necessary.

Nice-to-haves

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

Benefits

• Health insurance coverage
• Dental insurance coverage
• 401k retirement savings plan
• Flexible scheduling options
• Paid holidays and vacation time
• Professional development opportunities
• Employee discount programs