Clinical Research Manager (CRM) - Immunology (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 Immunology at Merck is a pivotal role responsible for overseeing the end-to-end performance and project management of assigned clinical protocols across various countries. This position ensures compliance with ICH/GCP guidelines, local regulations, and the company's internal policies and quality standards. The CRM serves 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 driving the execution of clinical studies from feasibility and site selection through to recruitment, execution, and closeout, ensuring that all deliverables and timelines are met effectively. In this role, the CRM will lead local study teams, providing training on protocols and collaborating closely with Clinical Research Associates (CRAs) and other local roles to ensure high performance and compliance. The CRM is also responsible for creating and executing local risk management plans, conducting quality control visits, and reviewing monitoring visit reports to identify and escalate any performance issues. The CRM will work with functional outsourcing vendors and investigators, managing relationships and ensuring that the studies are conducted in alignment with the company's strategic goals. The position requires strong project management skills, a deep understanding of the clinical research landscape, and the ability to navigate complex regulatory environments. The CRM must be adept at communicating effectively in a remote setting, managing resources, and driving project delivery while maintaining high standards of quality and compliance. This role also involves strategic thinking and the ability to identify and mitigate risks early in the process, ensuring that the clinical trials are executed smoothly and efficiently.

Responsibilities

• Serve as the main point of contact for assigned protocols and link between Country Operations and the 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 quality standards.
• 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 investigators for assigned studies.
• Support local and regional strategy development in conjunction with CRD and Regional Operations.

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 environments is essential.
• Proficiency in written and spoken English and local language is required.
• Strong organizational skills and the ability to manage multiple deliverables simultaneously are necessary.
• Experience in project management and site management is required.
• Strong scientific and clinical research knowledge is essential.

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
• Professional development opportunities
• Tuition reimbursement
• Employee discount programs