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The Senior Global Study Leader (SGSL) is a business-critical role within Study Management Late, whose main accountability is the operational planning and delivery of high priority and complex clinical studies within a program, or across programs. Is responsible for leading a cross-functional study team (core and extended) and for providing the team with direction and mentorship to enable successful study delivery. The SGSL may provide input to early study planning activities based on operational expertise and 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 collaboration within the study team. Will also work with other internal customers cross-functionally, and/or external partners, to identify, manage and resolve issues affecting study delivery. The role holder is responsible for providing expert input, guidance, direction, mentoring, and support to GSLs on all study related operational activities and will lead other non-drug programs and improvement projects if needed.

Typical Accountabilities

• Lead and coordinate a cross-functional study team of professionals in accordance with Study Team Operating Model and its roles, accountabilities and responsibilities framework (RACI) to ensure the clinical study progress as planned driving achievement of milestones.
• Contribute to vendor/ESP selection activities, including bid defense, and lead operational oversight 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, collaborating with other cross-functional partners and the TA as required.
• Collaborate with other functions to establish strategies and identify alliances sought at growing efficiency of global study teams.
• Lead and facilitate communication across functions and provide mentorship to the 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, while ensuring that the appropriate level of oversight of the CRO is maintained and documented throughout the lifecycle of the study.
• Provide operational expertise into and hold accountability for the development of crucial study level documents.
• 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 partner concern pathways are clear to the entire study team.
• Lead all aspects of study level performance against agreed upon plans, milestones and key performance indicators (critical metrics, 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 and collaborate with all functions to overcome barriers and achieve milestones; proactively communicate findings and corrective action plans (CAPAs) to relevant partners.
• Coordinate Trial Master File (TMF) completion, including ensuring the TMF plan and Expected Document List (EDL) are in place and that QC activities are performed regularly to ensure TMF completeness.
• 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 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, professional input, mentoring 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

Essential:

• University degree (or equivalent), preferably in medical or biological sciences or subject area associated with clinical research
• At least 7 years of clinical trial experience and 3-4 years in global study leadership and team leadership
• 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.
• Confirmed project management experience on a global level (APM or similar training)

Desirable:

• Advanced degree, Masters level education (or higher)
• Project management certification
• Formal therapeutic area training
• Experience in all phases of a clinical study lifecycle

Next step - Apply today!

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.

Date Posted

Closing Date

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.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.