Associate Director, Senior Study Lead – Single Sponsor Dedicated
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Job Description
Associate Director Senior Study Lead leading cross-functional clinical trial teams at IQVIA. Ensuring operational excellence in clinical studies while navigating a matrix environment.
Responsibilities:
- 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 study budget.
- Proactive, iterative operational planning with effective contingencies and embedded risk management mindset in CTT.
Requirements:
- 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.
Benefits:
- None specified
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