Associate Director Senior Study Lead - Single Sponsor Dedicated (home-based)

Associate Director Senior Study Lead - Single Sponsor Dedicated (home-based)

Reading, United Kingdom Full time Home-based R

Job Purpose

The Associate Director Senior Study Lead is the leader of the cross-functional clinical trial team (CTT). The role guides planning and management of assigned clinical study/studies from end-to-end to achieve objectives, including proactive operational planning, risk management, budget and people allocation, and promotion of operational excellence through process improvement and knowledge sharing.

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 protocols, study reports, 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) required; advanced degree strongly preferred.
• 4 years recent involvement in clinical research or drug development spanning Phases I to IV of standard to high complexity and priority.
• 3 years recent contribution to and accomplishment in all aspects of conducting clinical studies of standard to high complexity and priority in a global/matrix environment in a pharmaceutical industry or contract research organization, including expert knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), local/National Health Authorities.
• Experience managing people globally in a complex matrix environment preferred.
• Proven ability and strong experience leading virtual teams and building capabilities; effective stakeholder relationship development.
• 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 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 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.

The potential base pay range for this role, when annualized, is 217.800,00 zł - 521.000,00 zł. The actual base pay offered may vary based on a number of factors including job related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.