Shraddha Karbele

• Efficiently managing team of 10 Data Manager professionals.
• Responsible for attaining all requirements from Client for quality deliverables.
• Monitor discrepancy management in accordance with the agreed timelines.
• Identify issues with validation procedures during study conduct and communicates the findings to Therapeutic Lead and Client.
• Communicates site data issues with Therapeutic Lead, Sites, Monitors, colleagues and Client as necessary.
• Monitors and supports SAE reconciliation, Vendor data reconciliation, discrepancy management (front end checks, programmed consistency checks).
• Ensure error free, quality data with no open queries before data base lock.
• Responsible for work allocation to the team and tracking status.
• Participate in teleconferences with Client.
• Monitor and review Manpower utilization.
• Ensure the team members meet all the SLA's (Quality, Productivity and TAT)
• Responsible for audit ready documentation throughout the trial and prepare the team members for the same.
• Complete team members periodic appraisal cycles and evaluations on time.
• Mentor / Train team members on ongoing basis.
• Produce a development plan for each team member in the team
• Assist in developing and implementing new techniques in day-to-day activity.
• Communicate with Group lead and other Team Leads on an ongoing basis to ensure the quality and delivery of the project in stipulated timelines.
• Coordinated resource allocation and scheduling to optimize project timelines and deliverables.

• Co-ordinate and lead the work of team and ensure proper work allocation.
• Understand and comply with core operating procedures and working instructions.
• Ensure timely and efficient delivery while adhering to standard procedures.
• Provide training, technical guidance and support to team members as required.
• Provide feedback.

Data Manager in Set-up, conduct and close out studies.

• Review protocol and create documents such as Data Handling plan, Mock CRF, Study plan specification, edit check specification and CRF completion guideline as per the project plan timelines and SLAs
• Prepare test scripts for Edit checks as well as derivations checks.
• Perform screen UAT, Edit checks UAT, Output UAT, Derivation procedures UAT, SAS Import/Export programs UAT and QC data extract views UAT along with correctly documenting the same in the UAT checklists as well as UAT log.
• Review and action queries on an ongoing basis and update database based on the query resolutions.
• Perform ongoing and final consistency checks, review protocol deviation handling document and data listings
• Communicates site data issues (dataflow, discrepancies, etc) with Sites, Monitors, Study Data Manager and colleagues on the Study Data Management Team.
• Perform various reconciliations (Third Party, IVRS and Safety) and share issue logs with respective teams.
• Perform QC of discrepancies monthly and provide feedback on the issues noted to the team members.
• During DBL, ensure that all the open discrepancies and missing data are resolved and the necessary database updates are performed and all CRFs have been verified and signed by the investigator.
• For Follow up to get all SAE and coding issues resolved on timely manner. Share various study metrics with all stakeholders when required and as defined in the metrics plan.
• Regularly attend study calls with all the stakeholders including Vendor and CRA for any study related issues, following up on missing data and queries and smooth locking of database.

• Perform ongoing data review and cleaning activities for assigned trial.
• Review and action queries on an ongoing basis and update database based on the query resolutions.
• Maintain Data management related operational data flows.
• Tracks and follows up on missing CRF pages and outstanding discrepancies.
• Review reports and take actions as defined in the DMP or CRF review manual.
• Provide listings for review to the client as per the timelines defined in the DMP.
• Perform ongoing and final consistency checks, review protocol deviation handling document and data listings.
• Co-ordination with internal coding and study team for Trial related status and communicating same to Clinical Trial Team.
• Ensure adherence to the project level SLAs and KPIs.
• Regular tracking of missing visits and communicating same to CRA' on timely manner.

• Provide assistance in resource management.
• Communicates site data issues (dataflow, discrepancies, etc) with Sites, Monitors, Study Data Manager and colleagues on the Study Data Management Team.
• Assisted in the preparation and maintenance of project documentation to support compliance with regulatory standards.
• Streamlined reporting processes, improving accuracy and efficiency of project status updates for management review.

• Managed documentation for regulatory submissions, ensuring compliance with industry standards.
• Administrative activities of site initiation visits.
• Track site selection process.
• Assist in EC Submissions to investigator sites.
• Update CTMS system on ongoing basis at Site/Country/study level.
• Enhanced team communication by organizing and maintaining accurate documentation of meeting notes, action items, and followups.