Global Trial Delivery Lead - Sponsor Dedicated
hace 3 días
Barcelona
ppThe bTrial Delivery Leader (TDL) /b serves as the bsingle point of accountability /b for btrial operational strategy, trial-level budget, quality, and on-time delivery /b of assigned clinical trials. This role represents the bevolution of the Global Trial Leader (GTL) /b, with a stronger emphasis on strategic leadership, end-to-end accountability, and governance-level decision making. /p pThe TDL works in close partnership with the bProgram Delivery Leader (PDL) /b and co-leads the bCross-Functional Trial Team (CFTT) /b to ensure trial strategies are aligned with program objectives and executed efficiently. /p pThe Trial Delivery Leader plays a bcritical role in ensuring clinical trials are delivered efficiently, compliantly, and with high quality /b, 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. /p h3Scope of Focus /h3 pThe Trial Delivery Leader Is Primarily Focused On Strategic Leadership And Execution Oversight, Rather Than Administrative Task Execution. Key Focus Areas Include /p ul liCo-leading the CFTT and driving cross-functional alignment /li liCoordinating functional strategies (e.g., trial endpoints, ARBM, biomarkers, DEICT, digital health, companion diagnostics) /li liEnsuring timely delivery of trial-level deliverables /li liTrial-level budget ownership and oversight /li liQuality oversight and inspection readiness /li liEarly operational input during initial protocol development /li liDevelopment of cost-optimized and accelerated scenarios and innovative approaches, aligned with trial tiering (post-POC) /li /ul h3Key Accountabilities /h3 ul liDevelop the trial operational strategy, integrating and aligning all trial-level functional strategies into a single, holistic approach, including vendor strategy. /li liPartner closely with the PDL to shape trial-level strategy in alignment with overall program strategy. /li liCo-lead the Cross-Functional Trial Team (CFTT), setting meeting cadence, agendas, and expectations. /li liEmpower CFTT members to independently drive their functional deliverables while maintaining accountability for timelines and quality. /li liServe as the single point of accountability for on-time delivery, quality, and trial-level budget across assigned trials. /li liEnsure all trial milestones, quality targets, and budget commitments are met. /li liProvide budget management and oversight at the trial level, including scenario planning and cost optimization. /li liReview and approve key study-level documents (e.g., global master ICFs). /li liProactively identify, assess, and mitigate trial-level risks, overseeing them through to closure. /li liDefine protocol deviation and resolution pathways. /li liTake ownership of study-level escalations, including vendor performance issues and enrollment risks. /li liCommunicate trial risks, issues, changes, and milestones to relevant stakeholders in a timely and transparent manner. /li liRepresent Global Development (GD) at trial-level therapeutic area (TA) governance forums. /li liContribute to and influence governance decisions, ensuring operational feasibility and alignment. /li liAttend Clinical Team (CT) meetings when requested by the PDL. /li liEnsure strong alignment with key stakeholders on protocol amendments, enrollment targets, and study changes. /li liEnsure all trial operational activities, TMF, and study documentation are health authority–compliant, inspection-ready, and meet required quality standards at all times. /li liSet 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. /li /ul h3Candidate Profile – Requirements /h3 ul liBachelor’s degree (BS) or equivalent in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy) /li li6–8 years of clinical trial management experience within the pharmaceutical industry or a CRO, including specific therapeutic area experience /li liProven experience managing clinical trials end to end, from start-up through database lock and trial close-out /li liStrong working knowledge of ICH-GCP, local laws, and regulatory requirements /li liSuperior clinical research operational knowledge with a demonstrated track record of delivery /li liAbility to ensure ongoing quality, compliance, and inspection readiness /li liDemonstrated effective leadership, with the ability to proactively guide study teams through key trial stages /li liProven ability to delegate effectively while maintaining accountability /li liExperience leading teams from formation to high-performance /li liStrong capability to manage multiple global stakeholders and cross-functional partners /li liProven experience coordinating global or regional teams in a virtual environment, for a minimum of 2 years (preferably 3+) /li liAbility to foster team productivity, alignment, and cohesiveness across geographies /li liStrong project planning and project management capabilities /li liProven experience in proactive planning, risk identification, and mitigation throughout the trial lifecycle /li liAbility to gain team consensus on updated plans during changing project circumstances /li liDemonstrated capacity for independent, complex decision making /li liSolution-oriented mindset with strong problem-solving skills /li liStrong IT skills, including proficiency with Microsoft applications and familiarity with: Trial Master File (TMF) Iinical Trial Management Systems (CTMS) /li liWillingness and ability to learn new systems and technologies /li liMonitoring experience is recommended; other relevant experience (e.g., data management or central monitoring) will be considered /li liExcellent verbal and written communication skills, supporting effective collaboration /li liProven experience developing presentations and presenting complex information to stakeholders /li liStrong analytical skills, with the ability to manage ambiguity when limited information is available /li liAbility to understand, plan, and oversee country- and vendor-level budgets /li liAwareness of country Out-of-Pocket (OOP) cost drivers and FTE-related cost components /li liWillingness to travel, as required /li liProficiency in English (spoken and written) and the local country language, as applicable /li liPlease note This role is not eligible for UK visa sponsorship /li /ul pPlease note: due to sponsor requirements for the role only candidates based in the listed location/s will be considered. Any applications from candidates based outside of these locations will not be considered. /p /p #J-18808-Ljbffr
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