Job Purpose
The Associate Director Senior Study Lead is the leader of the cross‑functional clinical trial team (CTT) who guides planning and management of the assigned clinical study/studies end‑to‑end to achieve objectives. The role is accountable for proactive, iterative operational planning with effective contingencies and an embedded risk‑management mindset in the CTT. The Associate Director oversees budget and people allocation within assigned studies and contributes to promoting operational excellence through process improvement and knowledge sharing across studies.
Key Accountabilities
- Executes and delivers clinical studies; guides planning and decision making at study level.
- Acts as the CTT product owner with clear and focused duties and responsibilities per the agile ways of working.
- Active member of a Clinical Operations community within the study leadership organization.
- Promotes operational excellence in the shared development of global clinical study protocol(s), clinical study report(s), and other study‑related documents.
Deliverables
- Patient recruitment, clinical data, study documentation and study reports.
- Efficient delivery of the protocol, ICF, monitoring plan, and CSR in quality and on time.
- Cost‑effective management of the study budget.
- Proactive, iterative operational planning with effective contingencies and embedded risk‑management mindset in CTT.
Key Expertise and Skillset
Bachelor’s degree in life sciences/healthcare (or clinically relevant degree) is required. An advanced degree is strongly preferred. Minimum of 4 years of recent involvement in clinical research or drug development spanning Phases I–IV with standard to high‑complexity and priority studies.
Minimum of 3 years of recent contribution to and accomplishment in all aspects of conducting clinical studies—including planning, executing, reporting, and publishing—at a global/matrix level in the pharmaceutical industry or a contract research organization, with expert knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), and local/national health authorities.
Experience in managing people globally in a complex matrix environment, leading virtual teams, and building capabilities. Proven ability to develop effective working relationships with internal and external stakeholders. Excellent communicator and presenter (oral and written), with strong organization and prioritization. Strong negotiation and conflict‑resolution skills and an enterprise mindset, with a demonstrated ability to drive aligned solutions. Fluency in English (oral and written).
Location
Home‑based. This role is not eligible for UK visa sponsorship. Candidates eligible only if based in the listed location(s); applications from candidates based outside these locations will not be considered.
Additional Information
Learn more at https://jobs.iqvia.com.
Application Notes
All information and credentials submitted in your application must be truthful and complete. False statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification or termination of employment if discovered later, in accordance with applicable law.
