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Clinical Operations Manager
hace 1 semana
We are seeking a skilled and experienced Clinical Operations Lead to oversee the clinical operations of our projects. The ideal candidate will have a strong background in clinical research, excellent leadership skills, and the ability to work effectively in a dynamic environment.
Key Responsibilities- Oversight of project deliverables, assigned Clinical Research Associate (CRA) and Investigator sites in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and local regulations.
- Primary liaison between the CRAs and the clinical project team.
- Project specific training of CRAs, conducting assessment visits with CRAs, implementation of enrollment and recruitment strategies, preparation of the monitoring plan and other structural documentation and the oversight of monitoring visit scheduling, site and monitoring performance metrics, issue escalation and corrective actions.
- College diploma/degree AND 7-9 years related experience + continuous training and knowledge/skills upgrading OR Undergraduate university degree (Bachelors or Honors Bachelors) AND 4-6 years' experience + substantial on-going job-related training.
- Health Sciences, Life Sciences or Nursing specialty preferred, or SoCRA and/or ACRP Certification/Designation.
- Minimum of 3 years CRA experience, strong experience with EDC systems, proficient with MS Office, strong written and verbal communication skills and highly effective interpersonal and organizational skills.
