Clinical Research Manager (CRM) - Immunology (REMOTE)

Merck KGaA Darmstadt Germany - Topeka, KS

Full-time - Mid Level

Remote - Topeka, KS

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 trial protocols across multiple countries. This position requires a deep understanding of ICH/GCP guidelines, local regulations, and the company's policies to ensure compliance and quality standards are met throughout the clinical trial process. 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 studies from feasibility and site selection through to recruitment, execution, and closeout, ensuring that all deliverables and timelines are met effectively. In addition to project management, the CRM is responsible for reviewing monitoring visit reports, escalating performance issues, and conducting quality control visits as necessary. The role involves leading local study teams, training team members on protocols, and ensuring strong collaboration among various local roles, including Clinical Research Associates (CRAs) and Country Operations Managers (COMs). The CRM also develops and executes local risk management plans, ensures compliance with key systems such as CTMS and eTMF, and identifies best practices across clinical trials. As a customer-facing role, the CRM builds and maintains business relationships with investigators and external partners, representing the company in a professional manner. The position also supports local and regional strategy development in alignment with long-term corporate goals, collaborating with various internal functions to address key issues and decisions across trials. The CRM must possess strong project management skills, a solid understanding of the local regulatory environment, and the ability to communicate effectively in a remote and virtual setting.

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 on protocols.
• 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, investigators, and external partners.
• Act as the country point of contact for programmatically outsourced trials.
• Build business relationships and represent the company with investigators.
• 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 organizational skills with demonstrated success in project management.
• Ability to make independent decisions and oversee clinical research activities.
• Strong understanding of the local regulatory environment and clinical trial management.
• Proficiency in written and spoken English and local language is required.
• Experience in managing resource allocation and project delivery.
• 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
• 401(k) retirement savings plan
• Flexible scheduling options
• Paid holidays and vacation time
• Professional development opportunities
• Employee discount programs