Job Title: Associate Director Senior Study Lead - Single Sponsor Dedicated (home-based)
Job Location: București, Romania
Job Location Type: Home-based
Job Contract Type: Full time
Job Seniority Level:
Job Purpose
Location: home-based, Slovakia, Romania, Spain or Portugal
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. Accountable for proactive, iterative operational planning with effective contingencies and embedded risk management mindset in CTT. Oversees budget and people allocation within assigned study/studies. Contributes 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
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
Key expertise and skillset
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
Location: Home-based
Please note this role is not eligible for the UK visa sponsorship.
Please note: due to sponsor requirements for the role only candidates based in the listed location/s will be considered. Any applications from candidates based outside of these locations will not be considered.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
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