Associate Director, Study Data Manager

Location: Barcelona - Spain (3 days working from the office and 2 days working from home)

Introduction to the role

As an Associate Director, Study Data Manager, you will provide leadership for Clinical Data Management (CDM) delivery across one or more studies or projects within the Oncology therapeutic area. You will oversee the delivery of high-quality data through external partners or internally run studies, and provide training and coaching to junior colleagues. You will maintain awareness of trends and changes in external CDM approaches and act as a subject matter expert in process development and improvement.

Typical Accountabilities

• Acts as a team leader and provides training or coaching to junior colleagues within CDM.
• Performs line management responsibilities such as performance appraisals and mentoring.
• Represents Clinical Data Management at cross functional forums, meetings and provides timely feedback to partners.
• Understands health authority requirements and provide input into the Clinical Data Management related activities associated with regulatory inspections/audits and liaison with Clinical Quality Assurance. Provides CDM leadership for assigned projects, indications and/or studies dependent on size and scale of the project. Takes global accountability and serves as the second line of contact at the project level.
• Demonstrates leadership and operational expertise in the strategic planning and delivery of CDM deliverables at project level. Management and oversight of vendor contracts, resourcing and budget management and oversight of vendor performance for assigned projects and studies.
• Communicates and negotiates effectively with all other project level team members.
• Demonstrates a business understanding of the compound profile to identify and assist in successful application of consistent CDM processes and documentation across assigned projects, (i.e., ensuring consistency across data quality plans.).
• Provide oversight and expertise of external service providers or in-house teams to deliver quality data with compliance to study model procedures and standards; give guidance on AZ standards, processes, systems and expectations to external partners, internal partners, and third-party vendors.
• Responsible for proactive risk management and issue resolution/escalation connected to Clinical Data Management improvement or technology.
• Develops an understanding of CDASH and SDTM or other recognized industry standards and impact to programming team to ensure consistency of program level standards.
• Specialist in TA specific data capture and standards, conducts lessons learned and disseminate across the organization as appropriate.
• Provides data management expertise in supporting strategic and operational aspects of Data Management on project level.
• Demonstrates willingness to take on and lead any project level activity consistent with current or experience in support of study delivery.
• Performs any CDM related ad-hoc requests from Line Manager

Education, Qualifications, Skills and Experience

Essential

• University or college degree in the life sciences or related subject, pharmacy, nursing or equivalent relevant degree.
• Ability to successfully manage simultaneous trials and meet deadlines.
• Significant Clinical Data Management experience, preferable both from CRO and Pharma industry in more than one therapeutic area.
• Excellent understanding of clinical trials methodology, GCP, GDMP and medical terminology.
• Comprehensive knowledge of clinical standards, e.g., SDTM or CDASH.
• High attention to detail and a strong analytical mind-set.
• Demonstrates a comprehensive knowledge of database structures and of capturing and storing clinical information as they apply to CRF design, database development, data handling and reporting.
• Excellent interpersonal skills and proven ability to operate effectively in a global environment.
• Good written and verbal communication skills, negotiation, collaboration, conflict management and interpersonal skills.
• Cultural awareness.
• Experience of CRO and vendor management.

Desirable

• Experience as a lead of a large Phase III trial or multiple smaller trials.
• Knowledge of SQL, 4GL, VBA or R software.
• Experience of managing teams.

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.