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

Merck KGaA Darmstadt Germany - Boise, ID

Full-time - Mid Level

Remote - Boise, ID

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 clinical trials within a designated country. This position is designed to ensure that all assigned protocols are executed in strict compliance with International Council for Harmonisation (ICH) guidelines, Good Clinical Practice (GCP), and local regulations. 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, driving, and tracking the execution of deliverables, timelines, and results to meet country commitments from the feasibility stage through site selection, recruitment, execution, and study close-out. In addition to project management responsibilities, the aCRM will be accountable for the performance of assigned protocols, ensuring adherence to quality standards and adverse event reporting requirements both internally and externally. The role includes reviewing monitoring visit reports, escalating performance issues, and identifying training needs to the CRA-Manager and other relevant stakeholders. Quality control visits will also be performed as necessary to maintain high standards throughout the study lifecycle. The aCRM will lead local study teams, providing training on the protocol to other local roles and closely collaborating with Clinical Research Associates (CRAs) to ensure a strong team dynamic. This includes coordinating activities across various local roles, such as Clinical Trial Coordinators (CTCs) and Clinical Operations Managers (COMs). A critical aspect of this position is the development and execution of a local risk management plan for assigned studies, ensuring compliance with Clinical Trial Management Systems (CTMS), electronic Trial Master Files (eTMF), and other key systems. Furthermore, the aCRM will be responsible for fostering collaboration with functional outsourcing vendors, investigators, and other external partners involved in the studies. As a customer-facing role, the aCRM will build and maintain business relationships, representing Merck with investigators and supporting local and regional strategy development that aligns with long-term corporate objectives. This position requires a collaborative spirit, as the aCRM will work closely with various internal functions, including headquarters, regional operations, and clinical development teams.

Responsibilities

• Main Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).
• Responsible for project management of the assigned studies, including planning, driving, and tracking execution and performance of deliverables/timelines/results.
• Accountable for performance for assigned protocols in compliance with ICH/GCP and country regulations, company policies, and quality standards.
• Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA-Manager and/or functional vendor and internal management as needed.
• Performs Quality control visits as required.
• Leads local study teams to high performance, trains local roles in the protocol, and supports CRAs as protocol expert.
• Responsible for creating and executing a local risk management plan for assigned studies.
• Ensures compliance with CTMS, eTMF, and other key systems in assigned studies.
• Escalates challenges and issues to TA-Head/CRD/CCQM and/or CTT as appropriate.
• Identifies and shares best practices.
• Responsible for collaboration with functional outsourcing vendors, investigators, and other external partners in assigned studies.
• Builds business relationships and represents the company with investigators.
• Supports local and regional strategy development consistent with long-term corporate needs in conjunction with CRD, TA-Head, and Regional Operations.
• Collaborates internally with HQ functions, regional and local operations, EU Clinical Development, Pharmacovigilance, and Regulatory Affairs.

Requirements

• Experience in clinical research or related field, with a strong understanding of ICH/GCP guidelines and local regulations.
• Proven project management skills with the ability to manage multiple studies simultaneously.
• Strong communication and interpersonal skills to effectively collaborate with internal and external stakeholders.
• Ability to analyze data and identify trends to improve study performance.
• Experience in risk management and quality control processes in clinical trials.

Nice-to-haves

• Experience with electronic Trial Master Files (eTMF) and Clinical Trial Management Systems (CTMS).
• Familiarity with infectious disease studies or therapeutic areas.
• Previous experience in a customer-facing role within the pharmaceutical or clinical research industry.

Benefits

• Health insurance coverage
• Dental insurance coverage
• 401k retirement savings plan
• Paid holidays
• Flexible scheduling options
• Professional development opportunities