Local Study Associate Director Cell Therapy

Location: Barcelona, Spain (on-site) 3 days/week working from the office.

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.

Short role description

To lead Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with AZ Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations. In addition to leading LST(s), the Local Study Associate Director (LSAD) may perform site monitoring as needed to support the flexible capacity model. The LSAD is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.

Typical Accountabilities

• Country Study Leadership: Own delivery of country study commitments and data quality, leading CRAs and CSAs to meet milestones and uphold GCP and local regulations.

• Feasibility and Site Selection: Drive robust feasibility assessments and identify high-potential sites/investigators; conduct Site Quality Risk Assessments and Site Qualification Visits to evaluate suitability and quality risks.

• Ethics and Regulatory Submissions: Ensure timely, complete submissions to Ethics Committees/IRBs and work with Regulatory Affairs on Regulatory Authority submissions throughout the study.

• Budget and Contracts: Prepare and maintain the country financial Study Management Agreement and accurate study budgets; develop the Master CSA (including site budgets) and amendments.

• Informed Consent and Essential Documents: Prepare country-level Master ICF and site ICFs, including translations, and confirm completeness of all essential documents prior to site activation.

• Investigational Product and Local Activities: Plan and coordinate local drug activities from purchase/reimbursement to destruction, in alignment with study needs and regulations.

• Systems and Data: Set up and maintain country-level CTMS entries and any required local websites per legal requirements to ensure data integrity and visibility.

• Monitoring Oversight and Quality: Oversee monitoring from activation to close, ensure adherence to Monitoring Plans, review monitoring reports, and provide proactive guidance to monitors; perform co-monitoring and accompanied visits as needed.

• Risk Management and Issue Resolution: Develop and maintain a country risk management plan, proactively identifying, mitigating, and resolving issues across sites, vendors, and stakeholders.

• Stakeholder Engagement and Communication: Lead regular Local Study Team meetings and maintain productive relationships with site staff and global stakeholders; provide clear, timely updates to the Global Study Team, including the SMM Lead.

• Investigator Engagement and Meetings: Contribute to recruitment strategy, maintain regular dialogue with investigators and, where applicable, National Coordinating/Lead Investigators; plan and lead National Investigator Meetings in line with local codes.

• Planning, Forecasting and Supplies: Forecast timelines, resources, recruitment, budgets, study materials, and drug supplies to keep studies on track.

• Compliance, Safety and Transparency Systems: Ensure local set-up and access to business-critical systems supporting safety reporting, regulatory submissions, and clinical trial transparency.

• Payments and Financial Control: Ensure accurate, timely payments aligned with agreements and local regulations.

• Team Development and Co-Monitoring: Train and coach new Local Study Team members; provide performance feedback on CRAs/CSAs and support capability building.

• - Inspection Readiness, Audits and Process Improvement: Maintain an inspection-ready eTMF with timely uploads; lead audit and inspection activities with CQAD and QA; contribute to process development and continuous improvement.

• Reporting and Performance Management: Provide regular study progress and milestone updates to line managers and escalate key issues promptly.

• Cross-Functional Collaboration: Ensure adherence to the Code of Ethics and all company policies; collaborate closely with Medical Affairs and support SMM initiatives at local, regional, or global levels.

Education, Qualifications, Skills and Experience

Essential

• Proven leadership of local study execution, delivering country-level study commitments and high-quality data in compliance with ICH-GCP and local regulations.

• Demonstrated expertise in clinical and operational feasibility, site identification, Site Quality Risk Assessment, and Site Qualification Visits.

• Strong track record managing ethics and regulatory submissions (EC/IRB and Regulatory Authority) from start-up through study duration.

• Experience preparing and managing study budgets and contracts, including fSMA, Master CSA, and site budgets, with accurate financial oversight and payments.

• Proficiency in preparing MICFs and site-level ICFs, including translations, aligned to SOPs and local requirements.

• Hands-on experience setting up and maintaining CTMS and any required local websites per legal obligations.

• Comprehensive monitoring oversight, including reviewing monitoring reports, providing proactive guidance, and conducting co-monitoring/accompanied visits.

• Advanced risk management skills, from country-level planning to issue identification, mitigation, and resolution across sites and vendors.

• Ability to lead effective Local Study Team meetings and maintain strong relationships with site staff and global stakeholders; clear communication and reporting to global study leadership.

• Direct involvement in patient recruitment strategy and engagement with National Coordinating/Lead Investigators; experience planning National Investigator Meetings.

• Competence in forecasting timelines, resources, recruitment, budget needs, study materials, and drug supplies.

• Set-up and management of systems supporting safety reporting, regulatory submissions, and clinical trial transparency.

• eTMF maintenance ensuring completeness and inspection readiness; leadership in audits and regulatory inspections with CQAD and QA.

• Coaching and performance feedback for CRAs/CSAs; onboarding and training of new study team members.

• Adherence to company Code of Ethics, SOPs, policies and procedures including SHE; contribution to process development and improvement.

• Collaboration with Medical Affairs and support for SMM initiatives at local, regional, or global level.

• Proficiency in English and Spanish is mandatory for this role.

Desirable Skills/Experience:

• Oncology clinical trial experience across phases and settings, with understanding of disease area complexities.

• Familiarity with innovative trial designs, novel endpoints, biomarker-driven strategies, and application of AI-enabled approaches in study operations.

• Strong vendor and site network management with evidence of accelerating start-up and recruitment.

• Experience leading investigator meetings and engaging national leaders to drive enrollment and quality.

• Proven record of process optimization and inspection/audit success.

• Comfort operating in a global matrix, influencing without authority, and balancing pace with quality.

Why AstraZeneca:

Here, science leads and collaboration amplifies impact. You will join an ambitious oncology engine with one of the deepest pipelines in the industry, working shoulder to shoulder with clinicians, statisticians, data scientists, and operations experts to design and deliver studies that shift standards of care. We pair courage with kindness, empowering you to take smart risks, learn fast from data, and bring forward innovations like biomarker-driven selection, modern endpoints, and advanced analytics. Your leadership at country level will connect directly to patients’ lives, turning complex protocols into reliable evidence that informs the next breakthrough.

Call to Action:

Step into this role to lead country studies that move the needle for patients—take the next step today and help deliver the next breakthrough in cancer care!

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.