Operations Manager, Data team

• Apr 2023 - Present

Project Data Manager

• Jan 2022 - Feb 2023

-Functional Lead for Data Management including primary contact for internal liaison between Data Management/Operations and Project Management, Clinical Monitoring, and other functional groups - Ensures launch, delivery and completion of all Data Management activities and milestones according to contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulations - Responsible for financial management of assigned projects / programs, including revenue recognition, changes in scope and participation in internal project review meetings, including liaison with Finance and Contracts groups as needed - Monitors and communicates project progress to the Sponsor and project team including use of project status reports and tracking tools/metrics to enable in stream data collection and query management - Developed and maintained project plans, specifications and documentation in line with SOP requirements - Maintains and upgrades documentations on an ongoing basis and ensures that all TMF filing is complete and up to date - Plan, manages and requests resources for assigned projects Show less

Clinical Data Lead

• May 2021 - Jan 2022

● First point of contact with other departments, sponsors and vendors for day-to-day activities.● Generated appropriate and timely status reports and provided them to the client, internal departments and senior management.● Created and maintained study documentation as required in accordance with SOPs.● Developed, reviewed and maintained relevant SSPs (for example, data management plan, edit check specifications, data transfer specifications, data handling conventions, laboratory data check specifications, SAE reconciliation)● Performed and assigned day-to-day data management activities ensuring timely delivery of each task within the overall study timelines Show less

Senior CDC

• Jan 2019 - Apr 2021

• Prepared eCRF specifications and finalized the same• Prepared Data Validation specifications, Test steps and performed UAT• Reviewed and finalized Protocol Deviation Document and Reviewed all protocol Deviations.• Create and maintains study files and other appropriate study documentation• Prepared Data review specs for EDC review and Vendor data reconciliations• Performed Data listings review and External Vendor Reconciliations• Worked on Post Production change activities• Prepared study specific documents like DMP, eCRF completion guidelines• Responsible for data flow, discrepancy Management, and all other data management related processes.• Appropriately addressing responses to data queries and accurately update the clinical data as necessary• Performed database lock activities and ensures all lock parameters have been met before lock is executed• Assisted with the development, review and the update of relevant Data Management Study Specific Procedures. • Effectively mentored less experienced staff. This may include assisting and guiding new personnel during their initial training period• Accurately performed Serious Adverse Event reconciliation and external data reconciliation in accordance with all applicable procedures. Show less

Lead Data Manager

• Feb 2017 - Dec 2018

Responsible for attaining all requirements from the client for quality deliverable Keep Project Plan up to date on ongoing basis and send to client Reviewing eCRF specifications prepared by Clinical Data Manager/ Clinical Database Programmer and finalization Reviewing and finalization of Protocol Deviation Document. Supporting in preparation of Data Transfer Agreement for Vendor. Reviewing DVR specifications and Test steps, UAT plan, UAT performance and UAT report by Clinical Data Manager. Monitoring discrepancy management in accordance with the agreed timelines. Reviewing all protocol Deviations. Responsible for data flow, discrepancy Management, and all other data management related processes. Communicating site data issues (dataflow, discrepancies, etc.) with TA Lead, Sites, Monitors, colleagues and Client as necessary. Supporting in execution of data listings programs and dataset reviews for patient data consistency, quality and completeness. Efficacy analysis and database closures. Performing and monitoring Data base lock and freezing activity. Hands-on production work along with Clinical Data Managers as and when need arises. Show less

Data Analyst - Lead data manager

• Jan 2016 - Feb 2017

Liaison with Data Sciences, Clinical &Field study team members in resolution of data issues Assess impact and initiate post-production changes and system updates Accountable for overseeing data cleaning activities Primary contact for study team for any data cleaning issues and system enhancements • Hosted Monthly Meetings with all stake holders about Study Health. • Ensured trial data integrity, system integrity, supports operational integrity, and maintains timeline integrity as key tenets of maintaining a healthy study • Developed and delivered trial-specific data cleaning plans • Performed database lock activities and ensures all lock parameters have been met before lock is executed • Created study-specific EDC training slides during study start-up • Ongoing engagement with different stakeholders of a trial; clinical, vendor, statistician etc. • Ongoing discrepancy management oversight and communication with Data Managers throughout study conduct • Performed impact assessment for protocol amendments • Prepared study specific documents like DMP, Edit check specification • Worked in Electronic questionnaire studies and handling DCF’s for the same Show less

Clinical Data Coordinator

• May 2015 - Dec 2015

Assist with the validation of edit check programs. Assist with the development, review and the update of relevant Data Management Study Specific Procedures. Accurately perform external data reconciliation in accordance with all applicable procedures.Generate, review for accuracy and distribute status reports as requested.CPT activities

Asst Clinical Data Associate

• Jun 2014 - May 2015

Identify and appropriately address data discrepancies in the clinical data via computerized edits and manual checks/listings.Independently generate and address responses to data queries or clinical data discrepant issues and accurately update the clinical data as necessary. Assist with the validation of edit check programs. Assist with the development, review and the update of relevant Data Management Study Specific Procedures. Accurately perform external data reconciliation in accordance with all applicable procedures.Generate, review for accuracy and distribute status reports as requested. Show less

Clinical Project Assistant

• Feb 2013 - May 2014

Central Data Entry Specialist

• Mar 2012 - Feb 2013

CRC

• 2010 - 2011