Global Study Associate Director

AstraZeneca; España; On-site; EUR 90,000 - 130,000; Full time

Job summary

AstraZeneca plc in Barcelona is seeking a Global Study Associate Director to lead cross-functional clinical studies from handover through close-out, ensuring delivery on time, budget and quality. This on-site role requires English fluency and collaboration with internal teams and external partners.

You will set strategy, remove obstacles, maintain inspection readiness and guide study teams across multiple countries, contributing to regulatory submissions and patient access.

Qualifications

• 5+ years of clinical experience in pharmaceutical industry and study management.
• Experience leading cross-functional study teams and vendor oversight.
• Strong knowledge of ICH-GCP and regulatory requirements.

Responsibilities

• Lead cross-functional study teams from handover to close-out.
• Ensure delivery against timelines, budgets and quality standards.
• Facilitate communication with external partners and investigators.
• Oversee TMF, risk management and quality plans.
• Maintain inspection readiness and support regulatory submissions.

Skills

Clinical study management

Project management

ICH-GCP knowledge

Education

University degree in medical or biological sciences

Job description

Introduction to role:

This role is based in Barcelona , with an on-site commitment of three days a week. Fluency in English is required.

Are you ready to lead global clinical studies that turn scientific breakthroughs into evidence for life-changing medicines? As a Global Study Associate Director , you will lead a cross-functional study team from handover through close-out and archiving, serving as the critical link between the study team and the Clinical Program Team. You will own study delivery against agreed timelines, budgets and quality standards, ensuring strong partnerships across internal functions and external partners so patients can benefit sooner.

You will set the direction, remove obstacles and uphold inspection readiness, while amplifying the impact of every function involved in the study. Your leadership will translate complex plans into predictable execution-shaping data that informs program decisions, regulatory submissions and patient access. Can you see yourself orchestrating multi-country operations with clarity, pace and quali ty?

Accountabilities:

• Lead, provide guidance and delegate appropriately to a cross-functional study team or oversee outsourced delivery activities to ensure the clinical study progresses as planned, driving achievement of milestones according to timelines, budget and quality standards. May hold accountability and/or oversight of several studies.
• Lead and facilitate communication across all functions, including external partners and service providers. Lead and conduct investigator meetings and other study related meetings.
• Provide input 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., Contract Research Organizations (CROs), central laboratories, IXRS, ePRO, etc.) engaged at the study level are performing to contracted goals and timelines/budget and that adequate oversight is documented and any issues are escalated appropriately. May participate in vendor selection activities.
• Develop and maintain relevant study plans 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.
• 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 performance indicators (KPIs, quality and operational).
• 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 system attestations, Clinical Trial Transparency)
• The GSAD is 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; GSAD is the primary Study Management 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; may mentor less experienced colleagues
• Work on non-drug project work such as being a Study Management representative in process improvements 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 Leadership.

Essential Skills/Experience:

• 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