- 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 development of global clinical study protocol(s), clinical study report(s), and other study-related documents
- 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 study budget
- Proactive, iterative operational planning with effective contingencies and embedded risk management mindset in CTT
- Bachelor's degree in life sciences/healthcare (or clinically relevant degree) is required. Advanced degree is strongly preferred.
- ≥ 4 years of recent involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV of standard to high complexity and priority ≥ 3 years of recent contribution to and accomplishment in all aspects of conducting clinical studies of standard to high complexity and priority (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry or a contract research organization, including expert knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), local/National Health Authorities
- Experience in managing people globally in a complex matrix environment preferred
- Management of virtual teams. Proven ability and strong experience leading teams and building capabilities Experience in developing effective working relationships with internal and external stakeholders
- Excellent communicator and presenter (oral and written); ability to communicate at all levels
- Excellent organization and prioritization
- Strong negotiation and conflict resolution skills and enterprise mindset, demonstrated by ability to drive for aligned solutions
- Fluent English, oral and written
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Study Project Lead, Associate Director, Single Sponsor Dedicated - Reading, United Kingdom - IQVIA
Description
Job Purpose
The Senior Study Leader is the leader of the cross-functional clinical trial team (CTT), guides planning and management of the assigned clinical study/studies end-to-end to achieve objectives. Accountable for proactive, iterative operational planning with effective contingencies and embedded risk management mindset in CTT. Oversee budget and people allocation within assigned study/studies. Contribute in promoting operational excellence through process improvement and knowledge sharing across studies. Fosters an empowered, psychologically safe organization that can navigate a matrix environment, learns, and adjusts quickly to changing conditions and business needs.
Key accountabilities
Deliverables
Key expertise and skillset
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at
