Senior Clinical Data Manager - Leading role

Senior Clinical Data Manager

Location: Warsaw, hybrid work (3 days from office, 2 days from home)

Responsible for coordination of the Clinical Data Management (CDM) deliverables on assigned clinical studies and may be an expert on CDM processes, standards, and technology. May act as a Core member of Global Study Team (GST) and may lead studies with less complexities. Collaborates with DM vendors and liaise with a variety of departments on a local and/or global level to ensure each study is run in accordance to the specifics of the model. Maintains Business Continuity for CDM processes and standards including integrity of the clinical database for the relevant studies. May work under direction of a Project Data Manager.

Typical Accountabilities:

• Coordinate the Clinical Data Management deliverables on assigned studies depending on the relevant model and DM Vendor. Takes accountability and serves as the first line of contact at the study level.
• Demonstrates leadership and operational knowledge in the planning and delivery of CDM deliverables at a study level potentially under mentorship from a Project Data Manager.
• Communicates and collaborates effectively with all study team members. Primary point of contact for DM vendor and provides guidance and supervision to Lead Data Manager/DM Team Lead working on the study (CRO or in-house).
• Oversight of day-to-day operational aspects of CDM for assigned studies; Responsible to identify risks and collaborate with the DM Vendor to mitigate the risk. Escalates issues/risks when necessary.
• Understands corporate, therapeutic/indication or program specific data capture AZ standards.
• Provide input into CDM related activities associated with regulatory inspections/audits for assigned studies.
• Responsible for compliance to Trial Master File requirements relating to DM Vendor
• Support Senior Leaders to oversee CDM Vendor performance, depending on relevant model. Review, assess and manage DM Vendor delivery against KPIs, budget and overall performance. Oversees vendor timelines and milestone deliverables for the assigned studies. Ensures DM Vendor billing is accurate and gives recommendations for payment of invoices.
• Drive adherence to AZ CDM standards and processes for data quality and consistency of data capturing for assigned studies.
• Demonstrates willingness to take on ad-hoc activities consistent with current CDM work experience.
• Ensures relevant training is completed prior to performing tasks.
• Mentoring junior Clinical Data Management colleagues
• Performs 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
• 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:

• 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