Global Study Associate Director R&I (permanent/fixed term/secondment)

AstraZeneca plc; Warszawa; On-site; PLN 240,000 - 360,000; Full time

Job summary

AstraZeneca plc Poland is seeking a Global Study Associate Director to lead a cross-functional study team in delivering clinical trials on time, within budget, and to high quality standards.

You will partner with the Clinical Program Team, manage external vendors, ensure TMF completeness, and mentor colleagues, shaping study management practices in line with ICH-GCP and AZ SOPs.

Qualifications

• University degree in medical or biological sciences with clinical research experience.
• 5+ years in pharma clinical research with 2+ years in project management.
• Solid knowledge of ICH-GCP and regulatory requirements.
• Proven leadership and cross-functional collaboration skills.

Responsibilities

• Lead cross-functional study team or oversee outsourced activities to meet milestones on time and within budget.
• Coordinate investigator meetings and study-related governance with external partners.
• Develop study plans and risk management strategies ensuring quality and compliance.
• Ensure TMF completeness and adherence to AZ SOPs and regulatory standards.
• Monitor budgets and provide timely financial risk and mitigation updates to CPT.
• Maintain inspection readiness and act as Study Management contact during audits.
• Provide performance feedback and mentor team members.

Skills

ICH-GCP knowledge

Clinical study management

Regulatory compliance

Team leadership

Communication skills

Education

University degree in medical or biological sciences

Tools

CTMS

EDC systems

Job description

The Global Study Associate Director (GSAD) is a business-critical role within Study Management, BioPharmaceuticals Clinical Operations, whose main accountability is the delivery of clinical studies. The GSAD is responsible for leading a cross-functional study team 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 handover 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, 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 behaviours.

Accountabilities

Lead, provide guidance and delegate appropriately to a cross-functional study team or overseeoutsourced delivery activities to ensure the clinical study progresses as planned, drivingachievement of milestones according to timelines, budget and quality standards. May holdaccountability and/or oversight of several studies.

• Lead and facilitate communication across all functions, including external partners and serviceproviders. Lead and conduct investigator meetings and other study related meetings.
• Provide input into and hold accountability for the development of essential study leveldocuments (i.e., Clinical Study Protocol (CSP) through to Clinical Study Report (CSR)) inaccordance with relevant AZ SOPs.
• Ensure all external service providers (i.e., Contract Research Organizations (CROs), centrallaboratories, IXRS, ePRO, etc.) engaged at the study level are performing to contracted goalsand timelines/budget and that adequate oversight is documented and any issues are escalatedappropriately. May participate in vendor selection activities.
• Develop and maintain relevant study plans including required input into study level quality andrisk management planning (e.g., risk-based quality management, proactive risk and contingencyplans, etc.) ensuring that the risk response strategies and issue escalation pathways are clear tothe entire study team
• Accountable for ensuring that information in all systems utilized at a study-level (e.g.ACCORD/ABACUS, PharmaCM, etc.) are current and accurate.
• Oversee study level performance against agreed upon plans, milestones and key performanceindicators (KPIs, quality and operational) by using company tracking systems and projecttimelines and communicate any risks to timelines and/or quality to CPT and sDSM/DSM alongwith proposed mitigations
• Identify and report quality issues that have occurred within the study in accordance withrelevant AZ SOP and collaborate with all functions as necessary to overcome barriers andachieve milestones; proactively communicate findings and corrective action plans (CAPAs) torelevant stakeholders (e.g. CPT, quality assurance staff, functional line management, etc.)
• Oversee Trial Master File (TMF) completion in accordance with relevant AZ SOPs, includingensuring 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 ofAuthority, Sunshine Act, financial system attestations, Clinical Trial Transparency)
• The GSAD is responsible for study budget re-forecasting following initial budget estimateprovided by the CPT and accountable for study budget management through the study lifecycleand for providing budget progress reports to the CPT including any financial risks and mitigationplans (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 relevantpolicies/guidelines; GSAD is the primary Study Management point-of-contact in the event of anaudit or inspection
• Provide regular feedback on individual performance to the study team members and their linemanagers to support their professional development; may mentor less experienced colleagues
• Work on non-drug project work such as being a Study Management representative in processimprovements and/or leading improvement projects as discussed and agreed upon with their manage
• May act as Subject Matter Expert for a particular process or system within Study Management.

Qualifications

• University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research 5 years of relevant clinical experience in the pharmaceutical industry, including 2 years’ project management experience, or equivalent combination of education, training and experience
• Extensive knowledge of ICH-GCP, clinical research regulatory requirements and demonstrated abilities in clinical study management processes and clinical/drug development
• Demonstrated solid project management skills and knowledge of relevant tools
• Strong, demonstrated abilities/skills in 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
• Excellent communication and interpersonal skills
• Strong strategic and critical thinking abilities
• Strong organizational and problem-solving skills
• Ability to manage competing priorities

Date Posted

13-paź-2026

Closing Date

25-paź-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.