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

$135,500 - $213,400/Yr

Merck KGaA Darmstadt Germany - Boston, MA

Full-time - Mid Level

Onsite - Boston, MA

Chemical Manufacturing

About the position

The Clinical Research Manager (CRM) is responsible for the end-to-end performance and project management of assigned clinical trial protocols within a specific country. This role ensures compliance with ICH/GCP guidelines, local regulations, and company policies while serving as the main point of contact between Country Operations and the clinical trial team. The CRM is accountable for project management, performance tracking, and collaboration with various stakeholders to meet study commitments and drive high performance in local study teams.

Responsibilities

• Act as the main point of contact for assigned protocols and link between Country Operations and the clinical trial team.
• Manage project timelines, execution, and performance of deliverables to meet country commitments from feasibility to close out.
• Ensure compliance with ICH/GCP, local 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, train local roles in the protocol, and coordinate activities across different local roles.
• Create and execute a local risk management plan 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 in assigned studies.

Requirements

• 5 years of experience in clinical research.
• CRA experience preferred.
• Trial management experience preferred.
• Bachelor's degree in Science or comparable field.
• Strong project management skills and/or project management certification.

Nice-to-haves

• Advanced degree (e.g., Master's degree, MD, PhD).
• Experience in Immunology or Infectious Diseases, specifically in the HIV therapeutic area.

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