Description
Job Duties & Responsibilities- Act as point of contact for the site: develop and maintain productive relationships
- Proactively oversee startup processes to ensure expeditious startup of studies. Work with CRO to overcome roadblocks and issues that may delay site initiation and activation.
- Support and drive in-country/regional study feasibility
- Develop close relationships with clinical site staff and Investigators as appropriate to ensure optimal Sponsor-site relationships
- Drive high quality through identification and management of issues at the country level, including understanding when decision making can occur at local level and when escalation to the global study team is required.
- Review visit reports (or output of CRO report review) from site qualification, initiation and monitoring visits as applicable
- As required, conduct sponsor oversight site visits (SOSVs) to assess site and CRO performance to:
- Assess the quality of site monitoring activities undertaken by CRO personnel. Escalate and support corrective actions as required.
- Evaluate clinical trial sites to ensure site procedures are performed in accordance with the study protocol, applicable study manuals, GCP, and local regulatory requirements
- Troubleshoot issues and implement alternative and innovative approaches to solve problems impacting clinical site delivery and/or quality
- Accountable for identifying site and CRA performance issues, quality events and other quality issues at patient and/or site level, escalating, and supporting implementation of CAPAs to address these
- Work both independently and collaboratively with cross-functional teams and country affiliates
- Maintain tools to document and track sponsor oversight activities and issues, as required
- Review reports (or output of CRO report review) from site qualification, initiation and monitoring visits as applicable
- Communicate important clinical site assessment information to the study team and CRO
- Support inspection readiness and site preparation activities in the event of a regulatory authority inspection and Interface with regulatory inspectors, as needed.
- Remain current with GCP and global regulatory requirements and have working knowledge of local/regional regulatory requirements for assigned regions
Qualifications
- Bachelor's Degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences or drug development is required.
- 8+ years of relevant experience in managing of clinical trials gained with a CRO or pharmaceutical company working on multinational clinical studies;
- Proven experience in the oversight and delivery of operational aspects of all stages of clinical trial process
- Extensive site management and monitoring experience across a range of highly complex disease areas
- Demonstrated capability of effective monitoring and site oversight
- Solid knowledge of clinical development processes with strong emphasis on monitoring
- Ability to lead, troubleshoot and influence for quality and delivery
- A track record of ensuring GCP compliance and successful risk management of complex clinical studies is expected
- Proven experience in effectively communicating with site staff including and including KOLs and thought leaders
- Comprehensive and current regulatory knowledge, including GCPs
- Experience conducting GCP or other training is a plus
- Demonstrates flexibility in schedule and willingness to travel frequently in assigned region (required travel may be as high as 70% during busy periods)
- Good organizational skills and ability to deal with competing priorities
Michael Bailey International is acting as an Employment Business in relation to this vacancy.