Senior Clinical Data Manager II

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 B iotech/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 phar