The Senior Global Study Leader (SGSL) is a business-critical role within Study Management Late, Biopharmaceuticals whose main accountability is the operational planning and delivery of high priority and complex clinical studies within a program, or across programs. The SGSL 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 SGSL may provide input to early study planning activities based on operational expertise. The SGSL is accountable to the CPT for the delivery of a study, or studies, according to agreed upon timelines, budget and quality standards by ensuring an effective partnership and teamwork within the study team. The SGSL will also interface with other internal stakeholders cross-functionally, and/or external partners, to identify, manage and resolve issues affecting study delivery.
The SGSL leads the study team(s) and/or study oversight team(s) in accordance with the Study Team Operating Model (STOM), AZ Project Management Framework and/or clinical outsourcing 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.
The SGSL is also responsible for providing expert input, guidance, direction, mentoring, and support to GSLs on all study related operational activities. The SGSL will also provide advice and support to GSLs related to study team leadership, senior stakeholder management, conflict management, etc. SGSLs will also lead other non-drug programs and improvement projects as required.
- 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.
- Contribute to vendor/ESP selection activities at the study level, including bid defense, and lead operational oversight at the study level in order to ensure appropriate control over the vendor identification and selection.
- Assist the Director, Study Management with the operational planning for upcoming clinical studies to establish required amount of resources for study conduct, interfacing with other cross-functional partners and the TA as required.
- Collaborate with other functions to establish strategies and identify synergies aimed at increasing efficiency of global study teams (core and extended).
- Lead and facilitate communication across functions and provide guidance and support to the core and extended study team members as needed and in accordance with study-specific communication plan.
- For outsourced studies, be the primary AZ point of contact for the CRO Study 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 operational expertise 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.
- 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 through planning & control activities.
- 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 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).
- 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; SGSL is the primary Study Management, Late point-of-contact in the event of an audit or inspection.
- Provide regular feedback on individual performance to the study team members and their line managers to support their professional development.
- Provide guidance, training, expert input, mentoring and support to less experienced GSL colleagues on an ongoing basis.
- Leads or contribute to non-drug project work such as SM representative in process improvements and/or improvement projects as discussed and agreed upon with their manager.
Education, Qualifications, Skills and Experience
- University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research
- At least 7 years of clinical trial experience
- At least 3 years of experience in global study leadership and team leadership with preferred 5 years of experience
- Demonstrated study management expertise/abilities eg.: in leading large phase 3 pivotal and studies with a high degree of complexity, or multiple smaller studies simultaneously.
- Proven project management experience on a global level (APM or similar training)
- Advanced degree, Masters level education (or higher)
- Project management certification
- Formal therapeutic area training
- Experience in all phases of a clinical study lifecycle