Senior Clinical Data Manager II

Job description

# **Job Title:** Senior Clinical Data Manager II # **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 study-level data strategy that transforms complex clinical information into decisions that move medicines to patients faster? Do you thrive at the intersection of standards, systems and collaboration, where high-quality data drives confident regulatory submissions and robust science? In this role, you will coordinate and deliver Clinical Data Management for global clinical studies, partnering closely with external vendors and cross-functional teams. Your leadership will ensure database integrity, consistent application of standards and inspection-ready documentation, accelerating how we learn from trials and shaping the path of our pipeline. You will join a team that combines scientific curiosity with advanced data and digital approaches to uncover insights and solve difficult problems. Here, your decisions will influence timelines, quality and patient impact across multiple therapy areas, while you continue to learn, stretch and contribute to work that breaks new ground. # **Accountabilities:** **- Study Data Leadership:** Coordinate CDM deliverables for assigned studies, serve as the first-line study contact and plan/deliver according to the operating model and vendor partnership, potentially under mentorship from a Project Data Manager. **- Vendor Oversight:** Act as the primary point of contact for the DM vendor; guide the Lead Data Manager/DM Team Lead; track performance against KPIs, timelines and milestones; review budgets and invoices and recommend payment. - **Risk Management:** Oversee day-to-day CDM operations; identify and mitigate risks with the DM vendor; escalate issues promptly to maintain study delivery. **- Standards and Data Quality:** Apply and drive adherence to corporate, therapeutic/program-specific data capture standards; safeguard database integrity and ensure consistency of data capture for analysis readiness. **- Inspection Readiness and TMF Compliance:** Provide input into activities related to regulatory inspections/audits for assigned studies; ensure compliance with Trial Master File requirements relating to the DM vendor. **- Cross-Functional Collaboration:** Communicate and collaborate effectively with study team members, statisticians, programmers, clinical and safety colleagues and external partners to anticipate needs and resolve issues. **- Training and Mentorship:** Ensure relevant training is completed prior to task execution; mentor junior Clinical Data Management colleagues and take on ad-hoc activities aligned with CDM experience. **- Business Continuity:** Maintain continuity of CDM processes and standards for assigned studies, contributing to consistent ways of working across programs. # **Essential Skills/Experience:** - University or college degree in the life sciences or related subject, pharmacy, nursing or equivalent relevant degree. - Knowledge of Clinical Data Management and experience in the Biotech/Pharma/CRO industry. - Demonstrated current understanding of Good Clinical Data Management Practices (GCDMP) and relevant regulatory requirements. - Demonstrated experience of clinical databases, different clinical data management systems and electronic data capture (EDC). - Demonstrate understanding and experience in query management process and reconciliation activities. - Ability to work flexibly on simultaneous projects and proactively manage time to meet own deadlines. - Excellent written and verbal communication skills. - Ability to work in a global team environment. - Excellent organizational and analytical skills and high attention to detail. # **Desirable Skills/Experience:** - Demonstrated knowledge of clinical and pharmaceutical drug development process - Demonstrated understanding of clinical data system design / development / validation and system interoperability. - Demonstrated ability to work effectively with external partners - Understanding of database structures, programming languages, data standards (CDISC) and practices as they apply to CRF design, database development, data handling and reporting - Knowledge of SQL or SAS software - Experience leading clinical studies as Data Management Lead 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 shape how data and science come together to tackle some of the most complex diseases, working across diverse indications and stages of development. We unite colleagues from different disciplines and partners from academia and industry to spark new ideas and move at pace, supported by modern data, digital and AI capabilities. It is an environment where curiosity is encouraged, learning is continuous and bold decisions are made with kindness and respect—so your expertise can grow while your work meaningfully advances medicines, with opportunities to share impactful results externally when science merits it. **Call to Action:** If you are ready to lead the quality and integrity of study data that accelerates life-changing medicines, take your next step with us today! **Date Posted** 16-oct-2026 **Closing Date** 30-oct-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.