Global Study Director

AstraZeneca; Warszawa; On-site; PLN 480,000 - 640,000; Full time

Job summary

AstraZeneca in Warsaw, Poland is seeking a Global Study Director to lead high-priority oncology studies, coordinating cross-functional teams and ensuring timely, budget-conscious delivery. The role focuses on guiding core and extended teams, interfacing with CROs, and driving study success through robust planning and governance.

The GSD will oversee study documentation, TMF completion, risk management, and quality control, while mentoring colleagues and contributing to process improvements

Qualifications

• University degree (or equivalent) in medical or biological sciences.
• Proven project management experience and training.
• At least 7 years of clinical trial experience.
• At least 3 years in global study leadership and team leadership.
• ICH-GCP knowledge and regulatory requirements experience.
• Strong cross-functional collaboration and stakeholder management.
• Excellent communication and mentoring abilities.

Responsibilities

• Lead cross-functional study teams and drive milestones within timelines, budget and quality.
• Oversee vendor selection and operational oversight at study level.
• Collaborate with functions to improve efficiency of global study teams.
• Provide guidance and support to core and extended study team members.
• Ensure TMF completion and document quality; manage QCs.
• Develop study plans and risk management for global studies.
• Manage study budget and provide progress reports with mitigations.
• Ensure inspections readiness and act as study operations point of contact.
• Mentor less experienced GSL colleagues and lead improvement projects.

Skills

Project management

Clinical trial expertise

ICH-GCP knowledge

Cross-functional collaboration

Mentoring

Stakeholder management

Problem solving

Education

University degree in medical/biological sciences

Advanced degree (desirable)

Tools

Project management software

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.

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, Sunshine Act, financial 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. GSD is the primary LDO Clinical Operations 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 non-drug project work such as LDO Clinical Operations representative in process improvements and/or leading 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
• Proven project management experience and training
• At least 7 years of clinical trial experience
• At least 3 years of experience in global study leadership and team leadership
• Demonstrated clinical trial expertise in Oncology
• Extensive knowledge of ICH-GCP guidelines and clinical research regulatory requirements and experience in all phases of clinical study delivery; startup, maintenance and close out
• Thorough understanding of the cross-functional clinical trial process eg. Data flow
• Strong strategic and critical thinking abilities
• Proven skillset and abilities in complex problem solving and decision-making
• Strong abilities in establishing and maintaining effective working relationships with senior stakeholders, along with strong conflict management skills
• Demonstrated abilities in mentoring
• Excellent communication and interpersonal skills
• Ability to manage multiple competing priorities
• Experience in external provider oversight and management

Desirable

• Advanced degree, Masters level education (or higher)
• Project management certification
• 5 years of experience in global study leadership and team leadership
• Significant Oncology expertise
• Expertise in different phases of a clinical delivery
• Experience with Project Management software solutions

Date Posted

21-sie-2026

Closing Date

28-sie-2026

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.