Clinical Research Manager (CRM) Immunology (REMOTE)

$135,500 - $213,400/Yr

Merck KGaA Darmstadt Germany - Boston, MA

Full-time - Mid Level

Onsite - Boston, MA

Chemical Manufacturing

About the position

The Clinical Research Manager (CRM) for Immunology 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 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 trials from feasibility and site selection through recruitment, execution, and closeout phases. In this capacity, the CRM is accountable for the performance of assigned protocols, ensuring that all activities are conducted in accordance with regulatory requirements and company standards. Responsibilities include 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 other stakeholders. Additionally, the CRM is responsible for creating and executing local risk management plans and ensuring compliance with key systems such as CTMS and eTMF. The CRM also plays a significant role in building business relationships with investigators and external partners, representing the company in a customer-facing capacity. This position requires strategic thinking and collaboration with internal functions, regional operations, and global medical affairs to align on key issues and decisions across trials. The CRM must possess strong project management skills, a deep understanding of the clinical research landscape, and the ability to navigate complex regulatory environments effectively.

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 and local regulations, as well as company 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 to ensure study integrity.
• 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 in 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.
• 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

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