Location: Barcelona, Spain (on-site) 3 days working from the office and 2 days working from home.
The Global Study Associate Director (GSAD) is responsible for the delivery of clinical studies, including quality, timelines, budgets, resources, investigational sites, vendors, and key project deliverables in compliance with SOPs, Regulatory requirements and ICH/GCP guidelines. The GSAD is responsible for leading a cross-functional study team (core and extended) and for providing the team with direction and guidance to enable successful study delivery. The GSAD is the main liaison between the study team and the Clinical Program Team (CPT) starting with study concept through to close-out and archiving.
The GSAD is accountable to the CPT for the delivery of a study according to agreed upon timelines, budget, and quality standards by ensuring an effective partnership and teamwork within study team and/or external partners. The GSAD leads the study team and/or study oversight team in accordance with the Study Team Operating Model (STOM), AZ Project Management Framework, the appropriate study delivery model, current clinical trial regulations (e.g., ICH GCP), AstraZeneca Standard Operating Procedures (AZ SOPs), AZ policies and best practices (e.g., AZ guidelines) and in line with AZ values and behaviors.
Typical Accountabilities: Lead and coordinate a cross-functional study team of experts in accordance with STOM and its roles, accountabilities and responsibilities framework (RACI) to ensure the clinical study progress as planned driving achievement of milestones according to timelines, budget and quality standards. Lead and facilitate communication across all functions and provide guidance and support to the core and extended study team members as needed and in accordance with study-specific communication plan. Lead and optimize the performance of study delivery teams ensuring GCP compliance, including provision of timely and accurate performance feedforward for study team members to the appropriate AZ manager or CRO representative. Ensure sponsor oversight throughout the conduct of the study. For outsourced studies, be the primary AZ point of contact for the CRO Project Manager to ensure study delivery according to agreed upon timelines, budget and quality standards. Provide input into and hold accountability for the development of essential study level documents (i.e. Clinical Study Protocol (CSP) through to Clinical Study Report (CSR)) in accordance with relevant AZ SOPs. Responsible for CRO and other clinically outsourced third party vendor oversight and ensure all external service providers engaged at the study level are performing to contracted goals and timelines/budget and that adequate oversight is documented. Develop and maintain relevant study plans including required input into study level quality and risk management planning ensuring that the risk response strategies and issue escalation pathways are clear to the entire study team. Oversee study level performance against agreed upon plans, milestones and key performance indicators (KPIs, quality and operational) by using company tracking systems and project timelines and communicate any risks to timelines and/or quality to CPT, along with proposed mitigations. Identify and report quality issues that have occurred within the study and collaborate with all functions as necessary to overcome barriers and achieve milestones. Oversee Trial Master File (TMF) completion in accordance with relevant AZ SOPs, including ensuring the TMF plan and Expected Document List (EDL) are in place and that QC activities are performed on an ongoing basis to ensure TMF completeness at all times. Ensure timely compliance with company-wide governance controls. The GSAD is responsible for study budget re-forecasting following initial budget estimate provided by the CPT and accountable for study budget management through the study lifecycle. Ensure studies are inspection-ready at all times according to ICH-GCP and AZ SOP and relevant policies/guidelines. Provide regular feedforward on individual performance to the study team members and their line managers to support their professional development. Work on non-drug project work such as leading process improvement projects or participate in workstreams as discussed and agreed upon with their manager. Education, Qualifications, Skills and Experience Essential:University level bachelor's degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research.Minimum of 5 years progressive experience in clinical research, with at least 3 years of clinical development project management experience, or equivalent.Extensive knowledge of clinical research regulatory requirements (incl ICH-GCP) and demonstrated abilities in clinical study management processes and clinical/drug development.Extensive and proven experience in driving operational delivery to timelines, costs and quality.Proven experience leading delivery through internal and external organizations.Strong, demonstrated abilities/skills in matrix team leadership.Strong abilities in establishing and maintaining effective working relationships with internal and external co-workers and stakeholders.Experience in providing clear requirements and selection of external contracts.Excellent communication and interpersonal skills.Strong strategic and critical thinking abilities.Strong organizational and problem-solving skills.Ability to manage competing priorities. Desirable:Higher university degree e.g., PhD, MSc.Program management certification.Proven project management experience on a global level.Experience in all phases of a clinical study lifecycle.Experience in variety of academic/CRO/Sponsor organizations and countries. Date Posted: 27-nov-2024
Closing Date: 11-dic-2024
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.
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