Associate Clinical Research Manager (aCRM) - Infectious Disease (REMOTE)

Merck KGaA Darmstadt Germany - Trenton, NJ

Full-time - Mid Level

Remote - Trenton, NJ

Chemical Manufacturing

About the position

The Associate Clinical Research Manager (aCRM) for Infectious Disease at Merck is a pivotal role that involves comprehensive project management and performance oversight for assigned clinical protocols within a specific country. This position is designed to ensure compliance with International Council for Harmonisation (ICH) guidelines, Good Clinical Practice (GCP), and local regulations, while also adhering to Merck's internal policies and quality standards. The aCRM will serve as the main point of contact for assigned protocols, acting as a crucial link between Country Operations and the Clinical Trial Team (CTT). This role requires a proactive approach to planning, executing, and tracking the performance of clinical studies from feasibility and site selection through to recruitment, execution, and closeout. In this role, the aCRM will be accountable for the overall performance of assigned protocols, ensuring that all activities are conducted in compliance with regulatory requirements and company standards. Responsibilities include reviewing monitoring visit reports, escalating performance issues, and conducting quality control visits as necessary. The aCRM will lead local study teams, providing training on protocols and ensuring strong collaboration among various local roles, including Clinical Research Associates (CRAs) and Clinical Trial Coordinators (CTCs). Additionally, the aCRM will be responsible for creating and executing local risk management plans and ensuring compliance with key systems such as the Clinical Trial Management System (CTMS) and electronic Trial Master File (eTMF). The position also involves collaboration with functional outsourcing vendors, investigators, and other external partners, as well as supporting local and regional strategy development in alignment with corporate needs. The aCRM will work closely with various internal functions, including Pharmacovigilance, Regulatory Affairs, and Global Medical Affairs, to ensure alignment on key issues and decisions across trials. This role is customer-facing, requiring the aCRM to build strong business relationships and represent Merck with investigators effectively. The position is remote, allowing for flexibility in work arrangements, but it does require up to 30% travel to meet the demands of the role.

Responsibilities

• Serve as the main point of contact for assigned protocols and link between Country Operations and the clinical trial team (CTT).
• Proactively plan, drive, and track execution and performance of deliverables/timelines/results to meet country commitments.
• Accountable for performance for assigned protocols in compliance with ICH/GCP and country regulations, company policies, and quality standards.
• Review monitoring visit reports and escalate performance issues and training needs to CRA-Manager and/or functional vendor and internal management as needed.
• Perform quality control visits as required.
• Lead local study teams to high performance, training local roles in the protocol and coordinating activities across different local country roles.
• Create and execute a local risk management plan for assigned studies.
• Ensure compliance with CTMS, eTMF, and other key systems in assigned studies.
• Escalate challenges and issues to TA-Head/CRD/CCQM and/or CTT as appropriate.
• Identify and share best practices.
• Collaborate with functional outsourcing vendors, investigators, and other external partners in assigned studies.
• Support local and regional strategy development consistent with long-term corporate needs in conjunction with CRD, TA-Head, and Regional Operations.
• Collaborate internally with HQ functions, regional and local operations, and other departments to align on key issues/decisions across trials.

Requirements

• Knowledge in project management and/or site management.
• Strong organizational skills with demonstrated success in related roles or disciplines.
• Ability to make decisions independently and oversee important activities relevant to clinical research activities.
• Understanding of the local regulatory environment.
• Scientific and clinical research knowledge is required.
• Understanding of clinical trial planning, management, and metrics is essential.
• Ability to function as a key link between Country Operations and Clinical Trial Teams.
• Effective communication skills and ability to build collaboration in a remote/virtual environment.
• Ability to manage processes, productivity, quality, and project delivery.
• Proficiency in written and spoken English and local language.

Nice-to-haves

• Aptitude for building leadership skills that enable and drive alignment with the goals, purpose, and mission of the company.
• Strategic thinking and ability to work efficiently in a remote and virtual environment.