Purpose
- Advance AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine for patients, and leveraging new capabilities to drive industry-leading performance.
- Partner with investigators and site staff to support meaningful engagements and position AbbVie as the choice in clinical trials.
- Focus on site clinical research to ensure appropriate trial conduct and improve data integrity, compliance, study performance, and customer experience.
Responsibilities
- Primary point of contact for the investigative site; provide clinical trial context, connect stakeholders to sites, and strengthen AbbVieβs positioning.
- Align, train, and motivate site staff and the principal investigator under supervision.
- Under supervision, conduct site evaluation, training, routine, and closure monitoring in compliance with protocol, monitoring plans, applicable regulations, GCP/ICH guidelines, AbbVie SOPs, and quality standards to protect study subjects.
- Customize site engagement strategy for assigned study(ies) under supervision; gather local insights and use tools (e.g., CRM) to track progress and measure impact.
- Apply protocol/scientific concepts to day-to-day execution; evaluate recruitment and retention plans; develop therapeutic area/asset/patient journey knowledge to support recruitment and protocol compliance.
- Proactively perform risk assessment; collaborate with the Central Monitoring team to detect study performance or patient safety issues.
- Ensure preventative and corrective action plans are implemented to mitigate risk and promote compliance.
- Identify, evaluate, and recommend new/potential investigators/sites under supervision.
- Ensure data quality and timely submission, including reporting and follow-up for safety events.
- Maintain audit/regulatory inspection readiness; manage investigator payments per contract.
Qualifications
- Tertiary qualification in a health-related discipline (Medical, Scientific, Nursing) or equivalent experience.
- Clinically related experience, preferably in clinical research coordination or data management.
- Preferred knowledge of therapeutic area indications and ability to apply scientific concepts to clinical trial conduct.
- Knowledge of local regulatory/legal requirements, ICH/GCP guidelines, and applicable policies.
- Collaborative, cross-functional skills; strong planning/organizational ability in a dynamic environment.
- Ability to leverage technology/tools for customer-centric site support; use critical thinking and judgment to address site issues.
- Strong written/verbal/presentation and listening skills; ability to build trusted site partnerships.
- Acts with integrity and leadership values; self-motivated, focused on timely, quality outcomes.