Remote Senior CRA Team Lead Vaccine & ID Trials

Merck; Honolulu (HI); Remote; USD 156,000 - 211,000; Full time

Job summary

Merck is seeking an Associate Director to lead a team of 6–14 CRAs in clinical trial monitoring, ensuring study and site performance with strict adherence to ICH GCP and local regulations. The role works with country stakeholders and PLMs to align monitoring, capacity planning, and resource allocation across Vaccine/ID and related areas.

The candidate will mentor CRAs, manage performance, and escalate issues to the Head of Site Management and Monitoring while supporting HR and finance interfaces

Qualifications

• Minimum of 5 years’ experience within Clinical Research.
• Minimum of 3 years’ experience as CRA monitoring clinical trials.
• Line management experience preferred or team leader experience.

Responsibilities

• Work allocation, staff development and performance appraisal.
• Support departmental company initiatives and workstreams.
• Provides input for capacity planning, including reporting of current manpower and forecasting of CRA capacity and needs, to provide efficient use of resources.
• Work with CRAs, PLMS and other functions to ensure consistency of processes and protocol implementation across the country, to reduce variability and provide predictability.
• Interacts with sites as needed to resolve site or CRA operational issues to meet commitments in a timely manner in coordination with the study CRM.
• Attend local Investigator Meetings if requested to.
• Interface with GCTO partners on clinical trial execution.
• Escalates site performance issues to Head of Site Management and Monitoring.
• People and Resource Management:
• Manage CRA – career development, performance reviews, etc., including addressing low performance situations, and taking appropriate actions.
• Support and resolve escalation of issues from CRAs.
• Liaise with local HR and finance functions as required.
• Contribute to HQ capacity/resource planning activities to ensure efficient allocation of resources and work. Manage local conflicts between resource and work.
• Provides training, support and mentoring to the CRA to ensure continuous development.
• Ensures CRA compliance to corporate policies, procedures and quality standards

Skills

People management

Project management

Time management

Organizational skills

Leadership

Communication skills

ICH GCP

Education

Bachelor's degree in Science

Advanced degree

Tools

Trial management systems

Job description

Merck is seeking an Associate Director to lead a team of 6–14 CRAs in clinical trial monitoring, ensuring study and site performance with strict adherence to ICH GCP and local regulations. The role works with country stakeholders and PLMs to align monitoring, capacity planning, and resource allocation across Vaccine/ID and related areas.

The candidate will mentor CRAs, manage performance, and escalate issues to the Head of Site Management and Monitoring while supporting HR and finance interfaces