Remote CRA Manager - Lead Clinical Trials Team

Merck; Boise (ID); Remoto; USD 142.000 - 224.000; Tempo pieno

Descrizione del lavoro

Merck is seeking an Associate Director to lead a team of 6-14 CRAs and ensure high performance in Vaccine/Infectious Disease, with some cardiovascular focus. The role reports to the CRD or Head of Site Management and Monitoring, developing talent through mentoring, training and performance management while aligning with CRM and PLM stakeholders across the country.

You will drive capacity planning, resource allocation, and cross-functional process consistency to minimize variability and ensure

Competenze

• Minimum of 5 years of experience within Clinical Research.
• Minimum of 3 years of experience as CRA monitoring clinical trials.
• Line management experience preferred or at the minimum team leader experience.
• Fluent in Local Language and business proficient in English (verbal and written).
• Excellent working knowledge of ICH/GCP regulations and Good Documentation Practices.

Mansioni

• 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

Conoscenze

Clinical Research

Study Management

Regulatory Compliance

ICH GCP

People Management

Staff Leadership

Trial Protocols

Data Reporting

Interpersonal Skills

Formazione

Bachelor's degree in Science

Advanced degree in science

Descrizione del lavoro

Merck is seeking an Associate Director to lead a team of 6-14 CRAs and ensure high performance in Vaccine/Infectious Disease, with some cardiovascular focus. The role reports to the CRD or Head of Site Management and Monitoring, developing talent through mentoring, training and performance management while aligning with CRM and PLM stakeholders across the country.

You will drive capacity planning, resource allocation, and cross-functional process consistency to minimize variability and ensure