Purpose

Advance AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine for our patients and leveraging advancedcapabilities to drive industry leading performance. Partners with study teams, AbbVie internal R&D stakeholders, investigators, and site staff formeaningful and effective engagements positioning AbbVie as the partner of choice in clinical trials. Focus on site clinical research that ensuresappropriate conduct of the trial while driving improvement in data integrity, compliance, overall study performance and customer experience.

Responsibilities

Considered as the Pprimary Sponsor pPoint of contact for the investigative site. Advanced level of competency or experience in providingcontextual information on the clinical trials, connecting stakeholders to the investigative sites and strengthening Abbvie's positioning. Ability tomotivate and align monitoring community through leadership and mentorship."Aligns, trains and motivates the site staff and principalinvestigator on the goals of the clinical trial program, protocol, and patient treatment principles for the trial ensuring a trusted partnership. Able tosupport, guide, and mentor junior personnel on Site Management activities."Conducts site evaluation, site training, routine on-site and off-sitemonitoring, and site closure monitoring activities with compliance to the protocol and monitoring plans, in accordance with applicable regulations,Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards, ensuring safety and protectionof study subjects. Superior understanding of site engagement and ability to customize site engagement strategy for assigned study/ies and criticallyapply new strategies as needed. Gather local/site insights and utilize site engagement tools to report/track progress and measure impact of that strategy.Superior level of competency connecting the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial executionactivities. Expert understanding to 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 protocolcompliance."Possesses advanced level of competency to mentor and train less experienced CRAs on various aspects of work and provides inputinto their development. Supports local onboarding of more junior CRAs. Demonstrates ability to openly listen to and consider viewpoints to enhanceoutcomes. May participate/lead in global/local task forces and initiatives. Responsible for activities as assigned by manager. "Responsible forcontinuous risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect earlyoverall study performance or patient safety issues. Superior ability to think critically to resolve site risk signals while having robust understanding ofsite processes to drive study execution. Ensures preventative and corrective action plans are put into place, as needed, to mitigate risk and promotecompliance using a custIndependently Identifies, evaluates and recommends new/potential investigators/sites on an on going basis demonstratingexpert understanding and decision making. Potential sites may be identified through networking or internal AbbVie requests to assist in the placementof planned clinical studies with qualified investigators.Ensures quality of data submitted from study sites and assures timely submission of data,including appropriate reporting and follow-up for all safety events by site personnel. Ensures audit and regulatory inspection readiness at assignedclinical site at all times. Manages investigator payments as per executed contract obligations, as applicable.