The Clinical Operations Program Lead plays a pivotal role to provide input to optimize trial execution, coordinate governance interactions and product strategy.
This role maintains accountable to the Global & China Project Team (GPT/CNPT) for oversight across a program of global studies covering all clinical development deliverables including aspects of quality, resources, budget, timelines and risks. The responsibility spans from clinical program design & planning, through to clinical maintenance activities, data readout and clinical submissions in all phases of drug development.
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Typical Accountabilities
Provide program leadership for clinical operational strategy and deliverables:
- Collaborates with the Sr. GPD or (Associate) Director of Clinical Operations Program in determining possible program design options. Provides strategic oversight and feasibility input into the design of the clinical program.
- Collaborates with cross functions to establish strategies and identify synergies aimed at increasing operational efficiency to enable successful study delivery. Incorporates digital health and patient centric strategies into clinical studies to balance scientific intention and operational efficiency.
- Provides an accurate budget forecasting, maintenance, and monitoring to baseline, clinical program resourcing, scenario planning, plus overall timelines for trials within assigned program, including setup and maintenance within Company systems. Developing and managing of contingency risk plans within each assigned clinical program, including management of program issue escalation and resolution.
- Accountable for ensuring timely compliance with company-wide governance controls.
- Leads operational discussions with external experts/entities, including key opinion leaders, regulatory agencies, and other external collaborators to ensure robust operational design and execution.Demonstrates ability to set and lead priorities, resources, performance targets and project initiatives in a global and local environment.
- Responsible for the overall program management of a number of studies delivered by global study leaders, by overseeing quality, budget, resource, timelines and risks, identifying synergies aimed at increasing operational efficiency and providing the team with direction and guidance to enable successful study delivery.
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