Global Study Director

AstraZeneca; Poland; On-site; PLN 300,000 - 420,000; Full time

Job summary

AstraZeneca is seeking a Global Study Director (GSD) in Late Stage Oncology to lead operational planning and delivery of high-priority, complex clinical studies. You will guide cross-functional study teams, ensure timelines, budget and quality, and interface with internal/external partners to resolve delivery issues.

Emphasis on leadership, strategic input, and program-level oversight. The GSD will mentor GSADs, support study leadership, risk management, and governance across studies in line

Responsibilities

• Lead and coordinate cross-functional study teams to deliver clinical studies on time, within budget and quality standards.
• Provide guidance to core and extended study teams and ensure effective collaboration with internal and external partners.

Job description

The Global Study Director (GSD) is a business-critical role within Late Stage Oncology (LDO) whose main accountability is the operational planning and delivery of high priority and complex clinical studies within a program, that are deemed most critical to the business. The GSD 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 GSD may provide input to early study planning activities based on operational expertise. The GSD 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 GSD will also interface with other internal stakeholders cross-functionally, and/or external partners, to identify, manage and resolve issues affecting study delivery.

The GSD leads the study team(s) and/or study oversight team(s) in accordance with the Study Team Operating Model for Internal Delivery (SOLID), 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 GSD is also responsible for providing expert input, guidance, direction, mentoring, and support to GSADs on all study related operational activities. The GSD will also provide advice and support to GSADs related to study team leadership, senior stakeholder management, conflict management, etc. GSDs will also lead other non-drug programs and improvement projects as required.

Typical Accountabilities

• Lead and coordinate a cross-functional study team of experts in accordance with SOLID 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.
• 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,