Seba Pattnaik

• Review study start up activities that includes CRF review, Database specifications, Validation, Test script writing and User acceptance testing (UAT).
• Creation of Data Management Plan document.
• Managing resources assigned to a Project. Collaborate with internal teams to ensure consistent and accurate data handling throughout trial lifecycle.
• Coordinating data cleaning activity (Discrepancy management, DM listing review and SAE and IVRS reconciliation). Delegating data management team members to ensure quality standards are maintained and project deliverable timelines are met with minimal supervision.
• Chairing Project team meetings for assigned projects.
• Produces project-specific status reports such as Metrics and CPT for management, PM and/or clients on regular basis.
• Coordinate with resources assigned to project. Collaborate with internal teams to ensure consistent and accurate data handling throughout trial lifecycle.
• Conduct Quality Reviews for assigned studies and identifying root cause of findings
• Track project progress and ensure quality data is achieved.
• Comply with Standard Operating Procedures and Working Instructions.
• Actively involve in process improvement projects, identifying opportunities and implementing changes that streamlined data management workflows and increased efficiency.
• Filing study related documents in timely manner into eTMF tool
• Study specific training to junior associates.

Acts as point of contact for one or more projects.

• Ensure completeness and validity of clinical trials that has gone through data entry
• Attend and participate in protocol team meeting
• Perform discrepancies management for SAE related discrepancies
• Track discrepancies and query status of assigned investigational site
• Perform listing reviews, cleaning and consistency check
• Provide inputs to team lead to improve quality of work
• Perform IP reconciliation and SAE reconciliation
• Perform UAT for critical data modules of protocols
• Reviewing quality of work of resources by performing thorough QC, identifying root cause of errors and retraining resources