Clinical Research Manager (CRM) - Immunology (REMOTE)

Merck KGaA Darmstadt Germany - Oklahoma City, OK

Full-time - Mid Level

Remote - Oklahoma City, OK

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 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 foster a high-performance environment. The CRM is also responsible for creating and executing local risk management plans, ensuring compliance with key systems such as CTMS and eTMF, and identifying best practices across clinical trials. This position requires strong project management skills, the ability to communicate effectively in a remote environment, and a strategic mindset to support local and regional strategy development in alignment with corporate needs. The CRM will also engage with external partners, including functional outsourcing vendors and investigators, to build strong business relationships and represent the company effectively. This role demands a proactive approach to problem-solving, negotiation skills, and the ability to manage conflicts and challenges that may arise during the clinical trial process. The CRM will be expected to travel up to 30% of the time, reflecting the need for in-person engagement with stakeholders and site visits as necessary.

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 from feasibility to closeout.
• Ensure compliance with ICH/GCP, local regulations, and company policies throughout the clinical trial process.
• Review Monitoring Visit Reports and escalate performance issues to CRA manager and internal management as needed.
• Conduct Quality Control visits as required to ensure study integrity.
• Lead local study teams, providing training and support to CRAs and other local roles.
• 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 external partners for assigned studies.
• 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, TAH, and Regional Operations.
• Collaborate with HQ functions, regional and local operations, and other departments to align on key issues.

Requirements

• Bachelor's degree in Science or a comparable field is required.
• Minimum of 5 years of experience in clinical research is required.
• Experience as a Clinical Research Associate (CRA) is preferred.
• Strong knowledge of project management and site management is essential.
• Demonstrated success in organizational skills and decision-making capabilities.
• Strong understanding of the local regulatory environment and clinical trial processes.
• 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

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