Senior Clinical Data Manager II

About the role

AstraZeneca is looking for a Senior Clinical Data Manager II based in Barcelona, with an on-site commitment of three days a week and fluency in English required. The role coordinates and delivers Clinical Data Management for global clinical studies, partnering with external vendors and cross-functional teams to ensure database integrity, consistent application of standards and inspection-ready documentation.

Key responsibilities

• Coordinate CDM deliverables for assigned studies, act as the first-line study contact and plan and deliver within the operating model and vendor partnership, potentially under mentorship from a Project Data Manager.
• 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, and review budgets and invoices and recommend payment.
• Oversee day-to-day CDM operations, identify and mitigate risks with the vendor and escalate issues promptly.
• Apply and drive adherence to corporate and program-specific data capture standards, safeguard database integrity and ensure consistency of data capture for analysis readiness.
• Contribute to regulatory inspections and audits and ensure Trial Master File compliance for the DM vendor.
• Collaborate with study team members, statisticians, programmers, clinical and safety colleagues and external partners.
• Ensure training is completed before tasks are carried out, mentor junior Clinical Data Management colleagues and take on ad-hoc activities aligned with CDM experience.
• Maintain continuity of CDM processes and standards across studies and programs.

Required profile

• University or college degree in the life sciences or a related subject, pharmacy, nursing or an 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.
• Excellent written and verbal communication skills, ability to work in a global team and strong organisational and analytical skills with high attention to detail.

Required skills

• Demonstrated experience of clinical databases, data management systems and electronic data capture (EDC).
• Understanding of the query management process and reconciliation activities.
• Desirable: knowledge of CDISC data standards, SQL or SAS, and experience leading clinical studies as Data Management Lead.