Remote Clinical Research Manager – CRA Team Lead

Merck & Co., Inc; United States; Remote; USD 142,000 - 224,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Comprehensive benefits

Job summary

Merck & Co., Inc. in Rahway, NJ is seeking an Associate Director of Clinical Research Operations to lead a team of 6–14 CRAs, ensure trial and site performance, and uphold ICH GCP standards. The role involves country-level oversight, capacity planning, and cross-functional collaboration with CRM and PLM teams.

The position emphasizes talent development, mentoring, and ensuring adherence to SOPs while driving efficiency and quality across clinical monitoring activities.

Qualifications

• Bachelor's degree in Science.
• Minimum 5 years' experience within Clinical Research.
• Minimum 3 years' experience as CRA monitoring clinical trials.
• Line management experience preferred.
• Fluent in Local Language and business proficient in English.
• Excellent working knowledge of ICH/GCP regulations and Good Documentation Practices.

Responsibilities

• Lead staffing: work allocation, development, and performance appraisal.
• Support departmental initiatives and workstreams.
• Forecast CRA capacity and resource needs for efficient allocation.
• Ensure process/protocol consistency across country with local stakeholders.
• Resolve CRA/site operational issues in coordination with study CRM.
• Interact with sites and attend Investigator Meetings as required.
• Escalate site performance issues to Head of Site Management and Monitoring.
• Mentor and train CRAs to ensure continuous development.

Skills

Clinical Research

People Leadership

Project Management

ICH GCP Guidelines

Regulatory Compliance

Study Monitoring

Education

Bachelor's in Science

Tools

Trial Management Systems

Job description

Merck & Co., Inc. in Rahway, NJ is seeking an Associate Director of Clinical Research Operations to lead a team of 6–14 CRAs, ensure trial and site performance, and uphold ICH GCP standards. The role involves country-level oversight, capacity planning, and cross-functional collaboration with CRM and PLM teams.

The position emphasizes talent development, mentoring, and ensuring adherence to SOPs while driving efficiency and quality across clinical monitoring activities.