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)/Haematology Ways of Working, 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, while ensuring that the appropriate level of oversight of the CRO is maintained and documented throughout the lifecycle of the study, in accordance with relevant AZ SOPs and guidelines (e.g description of services and transfer of obligations). 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 (i.e. central laboratories, IXRS, ePRO, etc.) 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 (e.g. global study management plan and its relevant components such as study project plan SPP) including required input into study level quality and risk management planning (e.g. risk-based quality management, proactive risk and contingency DocuSign Envelope ID: A7F18F0F-AE28-4707-AB2C-D42FA6FF49AD plans, etc.) 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 (e.g. SPP, data flow metrics dashboard, CTMS or eTMF dashboard) 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 in accordance with relevant AZ SOP and collaborate with all functions as necessary to overcome barriers and achieve milestones; proactively communicate findings and corrective action plans (CAPAs) to relevant stakeholders (e.g. CPT, quality assurance staff, functional line management, etc.). 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 (e.g. Delegation of Authority, Sunshine Act, ACCORD attestations, Clinical Trial Transparency). 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 and for providing budget progress reports to the CPT including any financial risks and mitigation plans (as part of the ongoing study change control process). Ensure studies are inspection-ready at all times, according to ICH-GCP and AZ SOP and relevant policies/guidelines; GSAD is the primary Study Management & Operations (SMO) point-of- contact in the event of an audit or inspection. Provide regular feedforward on individual performance to the study team members and their line managers to support their professional development; may mentor less experienced colleagues. 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, along with strong conflict management skills. 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.
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