Clinical Operations Lead

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.

**Project Oversight**:

- Overall oversight of (a group of) regional CRAs to ensure (site) compliance with study protocol, study plans, ICH-GCP, local regulations and study timelines.
- Monitoring support visits (Co-monitoring), per project requirements, to aid the site/CRA in the satisfactory performance and compliance with standards mentioned above.
- May support clinical project team by providing oversight of study deliverables related to other departments (e.g. Data Management, TMF Operations, etc.)
- Oversee regional startup and feasibility activities.
- Assist in vendor management activities as required per project.
- Perform review of visit reports for quality, compliance and appropriate site management.
- Assure compliance with high quality and timely project deliverables according to the project requirements and the monitoring plan.
- Proactive management of site and country performance (recruitment, data collection, document collection, TMF review etc.) and inform clinical project team on progress.
- Contribute to financial project management processes as applicable. May include but may not be limited to input on revenue recognition, site payments, and site pass-through expense review.
- May be required to manage/oversee investigator sites including CRA responsibilities, on a temporary or permanent basis.

**Project Liaison**:

- Conduct regular global CRA calls with the monitoring and site management team, as well as individual/country CRA calls
- Attend meetings with Study Sponsor to provide status updates on country and site progress
- Provide operational support and guidance to the monitoring team throughout project.
- Provide project training/mentoring to regional CRAs on study procedures, clinical plans and guidelines, and timelines for the study. Ensures study specific training requirements are completed and documented.
- First point of contact for regional CRAs for study-specific questions and issues. Escalates to PM and other functions as appropriate.
- Support line managers by providing status updates on utilization and performance of CRAs.
- Liaise with line manager for assigning sites to CRAs following line manager allocation of a CRA resource to the project.
- Conduct CRA Assessment visits per departmental requirements to assess the performance of the CRA against their monitoring responsibilities.

**Study Documents and Plans**:

- Develop training materials and study tools for sites and CRAs, including monitoring plans.
- Develop and implement enrolment and recruitment strategies together with clinical project team.
- Develop presentation materials for and presents at Sponsor Kickoff meetings, Investigator meetings and Sponsor Calls (as needed), and prepares presentations for Site Qualification Visits and Site Initiation Visits.

**Qualifications**:

- 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

**Other**:

- Health Sciences, Life Sciences or Nursing specialty preferred, or SoCRA and/or ACRP Certification/Designation.
- Should have a minimum of 3 years CRA experience, have strong experience with EDC systems, be proficient with MS Office, have strong written and verbal communication skills and highly effective interpersonal and organizational skills.
- Demonstrate the following attributes: proactive, detail oriented, task-driven and highly organized.
- Demonstrate the critical elements of GCPs and local regulations as they relate to clinical monitoring, IRB/EC and Investigator responsibilities.
- Demonstrated ability in report writing and strong ability to critically understand clinical research documents.
- Ability to handle multiple tasks to meet deadlines in a dynamic environment.

**Working Conditions**:

- Home-based