About This Role
This senior-level role focuses on being the primary sponsor point of contact for investigative sites, providing contextual information on clinical trials, and strengthening AbbVie's position. It involves motivating and aligning monitoring communities through leadership and mentorship, and supporting junior personnel in site management activities.
Responsibilities
- Serve as the primary sponsor point of contact for investigative sites, providing contextual information on clinical trials and strengthening AbbVie's positioning
- Motivate and align the monitoring community through leadership and mentorship
- Align, train, and motivate site staff and principal investigators on clinical trial program goals, protocol, and patient treatment principles
- Support, guide, and mentor junior personnel on site management activities
- Conduct site evaluation, site training, routine on-site and off-site monitoring, and site closure monitoring activities in compliance with protocol, monitoring plans, regulations, GCPs, ICH Guidelines, AbbVie SOPs, and quality standards
- Develop and customize site engagement strategies for assigned studies and apply new strategies as needed
- Gather local/site insights and utilize site engagement tools to report/track progress and measure strategy impact
- Connect study protocol, scientific principles, and clinical trial requirements to day-to-day clinical trial execution activities
- Generate and ensure effective recruitment and retention techniques/plans based on the patient disease journey
- Develop solid knowledge of therapeutic area, asset, and clinical landscape/patient journey to enable successful patient recruitment and overall protocol compliance
- Mentor and train less experienced CRAs on various aspects of work and provide input into their development
- Support local onboarding of more junior CRAs
- Participate/lead in global/local task forces and initiatives as assigned by manager
- Conduct continuous risk-assessment proactively and in collaboration with the Central Monitoring team
- Monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues
- Think critically to resolve site risk signals while having a robust understanding of site processes to drive study execution
- Ensure preventative and corrective action plans are put into place, as needed, to mitigate risk and promote compliance
- Independently identify, evaluate, and recommend new/potential investigators/sites on an ongoing basis
- Ensure quality of data submitted from study sites and assure timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel
- Ensure audit and regulatory inspection readiness at assigned clinical site at all times
