Clinical Research Manager (CRM) Immunology (REMOTE)

$135,500 - $213,400/Yr

Merck & Co. - Rahway, NJ

Full-time - Mid Level

Onsite - Rahway, NJ

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 protocols across multiple countries. This position ensures compliance with ICH/GCP guidelines, local regulations, and the company'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). The role requires proactive planning, execution, and tracking of study deliverables, timelines, and results to meet country commitments from feasibility through to site selection, recruitment, execution, and closeout. In this role, the CRM is accountable for the performance of assigned protocols, ensuring adherence to quality standards and adverse event reporting requirements. 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 collaborating closely with Clinical Research Associates (CRAs) to ensure strong coordination across various local roles. 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 crucial role in building business relationships with investigators and external partners, serving as the country point of contact for programmatically outsourced trials. This position supports local and regional strategy development in alignment with long-term corporate needs and collaborates with various internal functions to address key issues and decisions across trials. The role requires 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, ensuring timelines and deliverables are met.
• Accountable for compliance with ICH/GCP and country regulations, as well as company policies and procedures.
• 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.

Requirements

• Bachelor's degree in Science or a comparable field is required; advanced degree (e.g., Master's, MD, PhD) is preferred.
• Minimum of 5 years of experience in clinical research, with CRA experience preferred.
• Strong knowledge in 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 planning.
• Proficiency in written and spoken English and local language is required.
• Ability to communicate effectively and build collaboration in a remote environment.
• Strong project management skills or certification in project management.

Nice-to-haves

• Experience in Immunology is preferred.
• Experience functioning as a key link between Country Operations and Clinical Trial Teams.

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