Clinical Trial Lead, Remote - Country Operations

Merck & Co.; Rahway (NJ); On-site; USD 117,000 - 184,000; Full time

Benefits offered by this job

Medical benefits

401(k) plan

Paid holidays

Job summary

Merck & Co., Rahway, NJ, is seeking a Clinical Trial Manager to oversee end-to-end performance and project management for assigned protocols, ensuring ICH/GCP and local regulatory compliance. You will serve as the main POC between Country Operations and the clinical trial team, coordinating cross-functional efforts and external partners.

You will lead local study teams, drive delivery, manage risks, and ensure CTMS/eTMF compliance while traveling up to 30% to sites and meetings.

Qualifications

• 4+ years of experience in clinical research.
• Bachelor's degree in science (or comparable).
• CRA experience preferred.
• Vaccine/Infectious Disease experience preferred.

Responsibilities

• Main POC for assigned protocols and link between Country Operations and clinical trial team (CTT).
• Project management of the assigned studies: plan, drive and track execution and performance to meet country commitments.
• Accountable for global compliance with ICH/GCP, local regulations, policies and quality standards.
• Review Monitoring Visit Reports and escalate performance issues to CRA-Manager or vendors as needed.
• Perform Quality control visits as required.
• Lead local study teams, train in protocol and coordinate activities across country roles.
• Create and execute a local risk management plan for assigned studies.
• Ensure compliance with CTMS, eTMF and other systems.
• Escalate challenges to TA-Head/CRD/CCQM and CTT as appropriate.
• Collaborate with external partners and investigators; represent company with investigators.

Skills

Project Management

Site Management

Organizational skills

Independent decision making

Local regulatory environment

Clinical research knowledge

Clinical trial planning

Written and spoken English

Remote collaboration

Strategic thinking

Education

Bachelor's degree in science

Job description

Merck & Co., Rahway, NJ, is seeking a Clinical Trial Manager to oversee end-to-end performance and project management for assigned protocols, ensuring ICH/GCP and local regulatory compliance. You will serve as the main POC between Country Operations and the clinical trial team, coordinating cross-functional efforts and external partners.

You will lead local study teams, drive delivery, manage risks, and ensure CTMS/eTMF compliance while traveling up to 30% to sites and meetings.