Protocol Review, planning & execution of DORA.Creating Study Design Specifications, Edit Check Specifications, Data Management Plan, eCRF Completion guidelines.Creating Data Review Plan, specification of J Review reports, and patient profiles.Oversight of data management activities and Data Review.External data Reconciliations.SAE Reconciliations.Protocol Deviation review and reporting.Inspection Readiness.PTMF filing.

Lead Data Manager for multiple global studies.Main point of contact for sponsor and external stake holders.Train team members.Perform QC activities.Inspection readiness.Smooth execution of the trial.Ensuring compliance to standards & processes.Review and ensure the activities are within the scope of Budget.Project management and ensure timelines are met.Review and Reporting of Protocol Deviations.Study Set up, Conduct, and Close out activities.

Protocol Review, CRF Design inputsCreating Edit Check Specifications, Data Management Plan, eCRF Completion guidelines, EDC Cleaning Plan, QC Plan, SAE Reconciliation Guidelines, Data Transfer guidelines, Local lab handling guidelines etc.User Acceptance Testing.Developing specifications for Custom Reports, SAS/Data review Reports etc.Oversight of data management activities.Mentor new team members.

Oversight of clinical data operations.Review of SAS and Manual reports.External data reconciliations.Protocol Deviations Review and reporting.SAE Reconciliation.Observe and report data trends.Escalate and follow up on outstanding data issues.DM Status metrics.

Query Management.Data Review.

Protocol Review, eCRF designEdit Checks DevelopmentQuery Management

Basic data review.Write data clarifications as directed by lead data manager and resolve data clarifications.Understand & comply with core operating procedures. & working instructions.Understand basic database structure.Develop & maintain good communications and working relationships with team.Escalate problems to the attention of data team lead.