Clinical Operations Lead (Clinical Trial Manager) (India)
- Role
- Operations
- Experience
- Lead
Open to IN only. Set where you work from to check your eligibility.
No BS summary
Clinical operations lead/clinical trial manager for India-based work in Delhi. Needs oversight of CRAs, investigator sites, monitoring plans, GCP/ICH compliance, enrollment/recruitment, deviations, metrics, and corrective actions.
Responsible for the clinical operations of a project within a defined regional/global level. Provides oversight of project deliverables, assigned Clinical Research Associate (CRAs) and Investigator sites in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and local regulations. The COL acts as a primary liaison between the CRAs and the clinical project team. Additional responsibilities include 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. The COL will develop study tools for site and CRA use, review visit reports, review and track protocol deviations, and support other objectives for clinical operations and the clinical project team.
What you'll do
- Responsible for the clinical operations of a project within a defined regional/global level.
- Provides oversight of project deliverables, assigned Clinical Research Associate (CRAs) and Investigator sites in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and local regulations.
- Acts as a 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.
- Oversight of monitoring visit scheduling, site and monitoring performance metrics, issue escalation and corrective actions.
- Develop study tools for site and CRA use.
- Review visit reports.
- Review and track protocol deviations.
- Support other objectives for clinical operations and the clinical project team.
Benefits
- Accommodations for persons with disabilities are available on request in respect of all aspects of the recruitment and selection lifecycle.
Healthcare company