Senior Clinical Data Manager II
India – Bangalore
Time Type: Full Time
Posted on: Posted Today
Job Requisition ID: R-184838
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re dedicated to being a Great Place to Work.
About the Role
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 an experienced Principal Project Data Manager.
- 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 Principle Project Data Manager.
- Communicates and collaborates effectively with all study level 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 the day to day operational aspects of CDM for assigned studies; Responsible to identify risks and collaborate with the DM Vendor to mitigate the risk.
- Understands therapeutic area, indication or program specific data capture standards and 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 turning point 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 or experience in support of CDM.
- Mentoring junior Clinical Data management colleagues.
- Performs any CDM related ad-hoc requests from Line Manager or superior.
Education, Qualifications, and 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 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 distributed team environment.
- Excellent organizational and analytical skills and high attention to detail.
- 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.
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