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 quality?

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/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.

Desirable Skills/Experience:

• Advanced degree, Masters level education (or higher).
• Project management certification.
• Proven project management experience on a global level.
• Experience in all phases of a clinical study lifecycle.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Why AstraZeneca: Here you will join a community that blends scientific curiosity with digital ingenuity to push boundaries and tackle complex disease. We bring different disciplines together to spark new ideas, partner widely across industry and academia, and channel data, AI and automation into practical breakthroughs. You will be empowered to experiment, trusted to lead meaningful change and supported by leaders who value kindness alongside ambition. The work you do to elevate external operations will directly advance our pipeline and, ultimately, the lives of patients who need new options.

Call to Action: If you are ready to scale operational excellence across a global partner network and turn insight into impact, step forward and help us deliver the next wave of transformative medicines today!

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.