.Location: Barcelona, Spain (On-site): We require 3 days working from the office and 2 days working from home.Join our Oncology R&D team as an Associate Director Study Leader, where you will be responsible for the delivery of clinical studies, ensuring quality, timelines, budgets, resources, and key project deliverables are met in compliance with SOPs, Regulatory requirements and ICH/GCP guidelines. This role provides matrix management of functional area representatives to cross-functional clinical study teams. The exact accountabilities will differ depending on the exact nature of the clinical program so a high degree of flexibility is required.Typical Accountabilities:Leads the delivery of the clinical study from concept to final CSR and through to study closure and archive to agreed budget, time, project standards, quality and scientific standards.May convene and lead the cross functional study team(s) for Early Oncology Clinical studies based on delivery model.Lead and optimize the performance of study delivery teams ensuring GCP compliance, including provision of timely and accurate performance feedback for study team members to the appropriate AZ manager or CRO representative.Contribute to preparation and delivery of study documents (e.G. Protocols/amendments, Informed Consent Form (ICF) documents detailing study delivery data management activities, etc.).Responsible for forecasting and day-to-day management of study timelines, budget, materials and detailed study level plans and feasibility assessment.Leads study recruitment and data delivery to agreed timelines and targets.Implement agreed study level process and technology for Early Oncology clinical studies.Manage to the agreed study timelines, budget, and resource and ensure the update of appropriate systems.Accountable for the quality of study planning information into relevant planning systems.Guide the study team in the development of outsourcing specifications and vendor selection.May manage the vendor(s) throughout the life of assigned clinical trial(s) based on delivery model.Responsible for oversight of CROs and other clinically outsourced third party vendors for outsourced studies and programs.Lead and conduct investigator meetings and other study related meetings.Identify and communicate resource gaps for assigned studies.Communicate study level reports and status updates for Early Oncology clinical studies.Lead the study delivery related activities associated with regulatory inspections/audits in liaison with Clinical Quality Assurance.Oversee the submission of trial-related and essential documents to the Trial Master File, maintenance and final closeout of TMF.Ensure sponsor oversight throughout the life of the study.Lead risk management and quality efforts to ensure study compliance and continual inspection readiness.Responsible for study level reporting of progress, risks and issues.Provision to procurement clear specifications for study specific outsourcing
