Clinical Research Manager (CRM) Immunology (REMOTE)

$135,500 - $213,400/Yr

Merck KGaA Darmstadt Germany - Springfield, IL

Full-time - Mid Level

Onsite - Springfield, IL

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 across multiple countries. This position ensures compliance with ICH/GCP guidelines, local regulations, and Merck's internal policies and procedures. 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 requires proactive planning, execution, and tracking of study deliverables, timelines, and results to meet country commitments from feasibility and site selection through to recruitment, execution, and closeout. In addition to project management, the CRM is accountable for the performance of assigned protocols, ensuring adherence to quality standards and adverse event reporting requirements. The role involves reviewing monitoring visit reports, escalating performance issues, and conducting quality control visits as necessary. The CRM leads local study teams, providing training on protocols and ensuring strong collaboration among various local roles, including Clinical Research Associates (CRAs) and Country Operations Managers (COMs). Furthermore, the CRM is responsible for creating and executing local risk management plans and ensuring compliance with key systems such as CTMS and eTMF. As a customer-facing role, the CRM builds business relationships with investigators and external partners, supporting local and regional strategy development in alignment with long-term corporate needs. The position requires effective collaboration with various internal functions, including Global Medical Affairs and Pharmacovigilance, to address key issues and decisions across trials. The CRM must possess strong project management skills, a deep 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, including planning, tracking deliverables, and ensuring timelines are met.
• Ensure compliance with ICH/GCP and country regulations, as well as internal policies and quality standards.
• Review monitoring visit reports and escalate performance issues to CRA manager and internal management 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 in assigned studies.
• Identify and share best practices across clinical trials and countries.
• Collaborate with functional outsourcing vendors, investigators, and other external partners for assigned studies.
• Support local and regional strategy development in conjunction with CRD, TAH, 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 knowledge of project management and site management is essential.
• Demonstrated strong organizational skills and the ability to make independent decisions.
• Strong understanding of the local regulatory environment and clinical trial management.
• Proficiency in written and spoken English and local language is required.
• Ability to work efficiently in a remote and virtual environment.

Nice-to-haves

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

Benefits

• Bonus eligibility
• Long-term incentive if applicable
• Health care and other insurance benefits for employee and family
• Retirement benefits
• Paid holidays
• Vacation
• Sick days