Associate Director, Study Data Manager

About the role

AstraZeneca is looking for an Associate Director, Study Data Manager based in Barcelona, Spain, working 3 days in the office and 2 days from home. You will lead Clinical Data Management (CDM) delivery across one or more studies or projects in the Oncology therapeutic area, delivering high-quality data through external partners or internally run studies, training and coaching junior colleagues, and acting as a subject matter expert in process development and improvement.

Key responsibilities

• Act as team leader, providing training and coaching to junior colleagues, and handle performance appraisals and mentoring.
• Represent Clinical Data Management at cross-functional forums and give timely feedback to partners.
• Understand health authority requirements and contribute to CDM activities linked to regulatory inspections and audits, liaising with Clinical Quality Assurance.
• Provide CDM leadership for assigned projects, indications and studies, taking global accountability and serving as the second line of contact at project level.
• Manage vendor contracts, resourcing and budgets, and oversee vendor performance.
• Communicate and negotiate with project team members and guide external partners, internal partners and third-party vendors on AZ standards, processes, systems and expectations.
• Handle proactive risk management and issue escalation, and develop knowledge of CDASH and SDTM so that programming teams follow consistent program-level standards.
• Specialise in therapeutic area-specific data capture and standards, share lessons learned, and support ad-hoc CDM requests from the line manager.

Required profile

• University or college degree in life sciences, pharmacy, nursing or an equivalent relevant degree.
• Significant Clinical Data Management experience, preferably from both CRO and pharma industries in more than one therapeutic area.
• Ability to manage simultaneous trials and meet deadlines.
• Excellent interpersonal skills, cultural awareness and proven ability to work in a global environment.
• Desirable: experience leading a large Phase III trial or several smaller trials, and experience managing teams.

Required skills

• Comprehensive knowledge of clinical standards such as SDTM or CDASH.
• Knowledge of database structures, CRF design, database development, data handling and reporting.
• Desirable: knowledge of SQL, 4GL, VBA or R software.