Trial Delivery Leader (TDL)
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) & 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
This role is not eligible for UK visa sponsorship
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📌 Global Trial Delivery Lead - Sponsor Dedicated (Bardi)
🏢 Altro
📍 Bardi