Clinical Research Manager (CRM) - Immunology (REMOTE)

Merck KGaA Darmstadt Germany - Boise, ID

Full-time - Mid Level

Remote - Boise, ID

Chemical Manufacturing

About the position

The Clinical Research Manager (CRM) for Immunology at Merck is a pivotal role that encompasses comprehensive project management and oversight for clinical trials across multiple countries. This position is primarily accountable for ensuring that all assigned protocols are executed in compliance with ICH/GCP guidelines, local regulations, and the company's internal policies and procedures. The CRM 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 eventual closeout of the studies. In addition to project management responsibilities, the CRM will be responsible for reviewing Monitoring Visit Reports, escalating performance issues, and identifying training needs for Clinical Research Associates (CRAs) and other team members. Quality control visits will also be part of the CRM's duties to ensure adherence to quality standards. The CRM will lead local study teams, providing training on protocols and fostering collaboration among various local roles, including CRAs and Clinical Trial Coordinators (CTCs). A critical aspect of this role is the development and execution of local risk management plans for assigned studies, ensuring compliance with Clinical Trial Management Systems (CTMS), electronic Trial Master Files (eTMF), and other essential systems. The CRM will also be responsible for identifying and sharing best practices across clinical trials and countries, collaborating with functional outsourcing vendors, investigators, and other external partners. As a customer-facing role, the CRM will build and maintain business relationships with investigators and may have the authority to sign contracts and manage budgets as needed, serving the local business needs of the company in their respective country.

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: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out.
• Accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our Company's policies and procedures, quality standards and adverse event reporting requirements internally and externally.
• 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 in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration (including the CTC, CRAs and COM).
• 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 as needed different challenges and issues to TA Head/CRD/CCQM and or CTT (as appropriate).
• Identifies and shares best practices across clinical trials, countries, clusters.
• Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies.
• Country POC for programmatically outsourced trials for assigned protocols.
• As a customer-facing role, this position will build business relationships and represent our Company with investigators.
• Serves local business needs as applicable in his/her country (if delegated can sign contracts and manage budgets).

Requirements

• Proven experience in clinical research management, particularly in immunology or related fields.
• Strong understanding of ICH/GCP guidelines and local regulatory requirements.
• Excellent project management skills with a track record of managing multiple studies simultaneously.
• Ability to lead and motivate local study teams to achieve high performance.
• Strong communication and interpersonal skills to build relationships with investigators and external partners.
• Experience with risk management and quality control in clinical trials.

Nice-to-haves

• Experience with electronic Trial Master Files (eTMF) and Clinical Trial Management Systems (CTMS).
• Familiarity with functional outsourcing and vendor management in clinical trials.
• Previous experience in a customer-facing role within the pharmaceutical industry.

Benefits

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