Clinical Research Manager (CRM) - Infectious Disease (REMOTE)

Merck KGaA Darmstadt Germany - Trenton, NJ

Full-time - Mid Level

Remote - Trenton, NJ

Chemical Manufacturing

About the position

The Clinical Research Manager (CRM) for Infectious Disease at Merck is responsible for overseeing the end-to-end performance and project management of clinical trials in compliance with regulatory standards and company policies. This remote position serves as the main point of contact for assigned protocols, ensuring effective collaboration between country operations and clinical trial teams. The CRM will manage multiple studies across various countries, focusing on project execution, compliance, and quality control while fostering strong relationships with external partners and stakeholders.

Responsibilities

• Act as the main point of contact for assigned protocols and link between Country Operations and clinical trial team (CTT).
• Manage project execution for assigned studies, ensuring timelines and deliverables are met.
• Ensure compliance with ICH/GCP, country regulations, and company policies for assigned protocols.
• Review monitoring visit reports and escalate performance issues as needed.
• Perform quality control visits as required.
• Lead local study teams, providing training and support on protocols.
• 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 and external partners for assigned studies.

Requirements

• Strong knowledge in project management and site management.
• Demonstrated organizational skills with a track record of success.
• Ability to make independent decisions and oversee clinical research activities.
• Strong understanding of the local regulatory environment.
• Proficient in scientific and clinical research knowledge.
• Experience in clinical trial planning, management, and metrics.
• Effective communication skills in a remote/virtual environment.
• Ability to manage resource allocation and project delivery.
• Proficiency in written and spoken English and local language.

Nice-to-haves

• Experience in managing multiple deliverables and protocols simultaneously.
• Strategic thinking skills.
• Understanding of cultural diversity.

Benefits

• Health insurance
• 401k plan
• Paid holidays
• Flexible scheduling
• Professional development opportunities