Global Trial Delivery Lead Reading

Global Trial Delivery Lead – Sponsor Dedicated

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.

Scope of Focus

• 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) setup

Candidate Profile – Requirements

• Bachelor’s degree (BS) or equivalent in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy)
• 6–8 years of clinical trial management experience within the pharmaceutical industry or a CRO, including specific therapeutic area experience
• Proven experience managing clinical trials end to end, from start-up through database lock and trial close-out
• Strong working knowledge of ICH-GCP, local laws, and regulatory requirements
• Superior clinical research operational knowledge with a demonstrated track record of delivery
• Ability to ensure ongoing quality, compliance, and inspection readiness
• Demonstrated effective leadership, with the ability to proactively guide study teams through key trial stages
• Proven ability to delegate effectively while maintaining accountability
• Experience leading teams from formation to high-performance
• Strong capability to manage multiple global stakeholders and cross-functional partners
• Proven experience coordinating global or regional teams in a virtual environment, for a minimum of 2 years (preferably 3+)
• Ability to foster team productivity, alignment, and cohesiveness across geographies
• Strong project planning and project management capabilities
• Proven experience in proactive planning, risk identification, and mitigation throughout the trial lifecycle
• Ability to gain team consensus on updated plans during changing project circumstances
• Demonstrated capacity for independent, complex decision making
• Solution-oriented mindset with strong problem-solving skills
• Strong IT skills, including proficiency with Microsoft applications and familiarity with: Trial Master File (TMF) & Clinical Trial Management Systems (CTMS)
• Willingness and ability to learn new systems and technologies
• Monitoring experience is recommended; other relevant experience (e.g., data management or central monitoring) will be considered
• Excellent verbal and written communication skills, supporting effective collaboration
• Proven experience developing presentations and presenting complex information to stakeholders
• Strong analytical skills, with the ability to manage ambiguity when limited information is available
• Ability to understand, plan, and oversee country- and vendor-level budgets
• Awareness of country Out-of-Pocket (OOP) cost drivers and FTE-related cost components
• Willingness to travel, as required
• Proficiency in English (spoken and written) and the local country language, as applicable

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