CLinical Operations Lead

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Main Responsibilities:

1. Quality Review Site Visits/Co-Monitoring

2. Site Management Interface 3. Global Study Management Interface

4. Review of Monitoring Visit Reports

5. Protocol feasibility and Site Selection

6. Study Start-up Activities

7. Study Conduct

8. Regulatory / Ethics / Health Authority responsibilities

9. Inspection Readiness, Compliance and Audit Responsiveness

10. Full Service CRO Oversight Education A scientific or technical degree in the healthcare area is preferred along with extensive knowledge of clinical trial methodology.

In general, candidates for this job would hold the following levels of education/experience:

§ BS/BSc/MS/MSc or equivalent + 4 years of clinical research experience

§ Ph.D./MD or equivalent + 2 years of clinical research experience Relevant Experience

§ Solid knowledge of clinical development processes with strong emphasis on monitoring

§ Demonstrated project management and strategic abilities across any phase of a study § Site Management/Monitoring (CRA) experience

§ Project management experience in the clinical development area

§ Ability to lead, troubleshoot and influence for delivery