Global Trial Delivery Lead - Sponsor Dedicated

IQVIA; Turbigo; In loco; EUR 70.000 - 90.000; Tempo pieno

Descrizione del lavoro

A global clinical research organization based in Italy is seeking a Trial Delivery Leader (TDL). This role is pivotal for ensuring operational strategy and quality in clinical trials. The TDL will co-lead cross-functional teams to ensure on-time delivery and alignment with program objectives. Candidates should possess a Bachelor's in Life Sciences and have 6–8 years of clinical trial management experience. Leadership, communication, and project management skills are essential for this role.

Competenze

• 6–8 years of clinical trial management experience within the pharmaceutical industry or a CRO.
• Proven experience managing clinical trials end to end.
• Strong working knowledge of ICH-GCP and regulatory requirements.

Mansioni

• Develop the trial operational strategy and ensure all trial milestones are met.
• Partner with the PDL to shape trial-level strategies.
• Proactively identify and mitigate trial-level risks.

Conoscenze

Clinical trial management

Leadership

Risk management

Project management

Stakeholder management

Budget management

Communication skills

Formazione

Bachelor’s degree in Life Sciences

Strumenti

Microsoft Office

Trial Master File (TMF)

Trial Management Systems (CTMS)

Descrizione del lavoro

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