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Global Trial Delivery Lead - Sponsor Dedicated
Job Description & How to Apply Below
Reading, Berkshire, United Kingdom:
Paris, France:
Budapest, Hungary:
Barcelona, Spain:
Prague, Czech Republic time type:
Full time posted on:
Posted 30+ Days Agojob requisition :
R1539797
The
** Trial Delivery Leader (TDL)
** serves as the
** single point of accountability
** for
** trial operational strategy, trial-level budget, quality, and on-time delivery
** of assigned clinical trials. This role represents the
** evolution of the Global Trial Leader (GTL)**, with a stronger emphasis on strategic leadership, end-to-end accountability, and governance-level decision making.
The TDL works in close partnership with the
** Program Delivery Leader (PDL)
** and co-leads the
** Cross-Functional Trial Team (CFTT)
** to ensure trial strategies are aligned with program objectives and executed efficiently.
The Trial Delivery Leader plays a
** critical role in ensuring clinical trials are delivered efficiently, compliantly, and with high quality**, while balancing speed, cost, and innovation. By serving as the single point of accountability, the TDL enables clearer decision making, stronger execution, and improved trial outcomes across the development portfolio## Scope of Focus The Trial Delivery Leader is primarily focused on
** strategic leadership and execution oversight**, rather than administrative task execution. Key focus areas include:
* Co-leading the CFTT and driving cross-functional alignment
* Coordinating functional strategies (e.g., trial endpoints, ARBM, biomarkers, DEICT, digital health, companion diagnostics)
* Ensuring timely delivery of
** trial-level deliverables
*** Trial-level
** budget ownership and oversight
*** Quality oversight and inspection readiness
* Early operational input during
** initial protocol development
*** Development of
** cost-optimized and accelerated scenarios
** and innovative approaches, aligned with trial tiering (post-POC)## Key Accountabilities
* Develop the
** trial operational strategy**, integrating and aligning all
** trial-level functional strategies
** into a single, holistic approach, including vendor strategy.
* Partner closely with the
** PDL
* * to shape trial-level strategy in alignment with overall program strategy.
* Co-lead the
** Cross-Functional Trial Team (CFTT)**, setting meeting cadence, agendas, and expectations.
* Empower CFTT members to independently drive their functional deliverables while maintaining accountability for timelines and quality.
* Serve as the
** single point of accountability
** for
** on-time delivery, quality, and trial-level budget
** across assigned trials.
* Ensure all
** trial milestones, quality targets, and budget commitments
** are met.
* Provide
** budget management and oversight
** at the trial level, including scenario planning and cost optimization.
* Review and approve key
** study-level documents** (e.g., global master ICFs).
* Proactively identify, assess, and mitigate
** trial-level risks**, overseeing them through to closure.
* Define
** protocol deviation and resolution pathways**.
* Take ownership of
** study-level escalations**, including vendor performance issues and enrollment risks.
* Communicate trial risks, issues, changes, and milestones to relevant stakeholders in a timely and transparent manner.* ### Represent
** Global Development (GD)
** at
** trial-level therapeutic area (TA) governance forums**.
* Contribute to and influence
** governance decisions**, ensuring operational feasibility and alignment.
* Attend
** Clinical Team (CT) meetings
** when requested by the PDL.
* Ensure strong alignment with key stakeholders on
** protocol amendments, enrollment targets, and study changes**.* ### Ensure all
** trial operational activities, TMF, and study documentation
** are
** health authority–compliant**, inspection-ready, and meet required quality standards at all times.
* Set up and oversee
** clinical trial systems and documentation**, including (but not limited to): E7 drivers, Safety Management Plan, JJAR & Unified Clinical Trial Team (UCT)…
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