Archana Shankar Email & Phone Number

United States

Maryland, United States

United States

Currently leading two studies in conduct phase.Work closely with all the stakeholders including sponsor and vendors.Act as point of contact to the sponsor for all study related activities.Allocate the work to the data managers regularly and coordinate with them to discuss their doubts and questions.Conduct regular meetings with sponsor and other stakeholders.Liaised with cross-functional department managers to prioritize project/study timelines to ensure adequate staffingEscalates issues when appropriate to the manager and global study teams in a timely mannerIdentified trends in data and possible solutions for efficienciesDeveloped DMP, DTA, CRF completion guidelines and other DM specific documents.Performed edit checks specification and cleaning listings, created UAT plan, test cases and performed UAT.Performed LAB reconciliation, SAE Reconciliation and coordinated with vendors till the issues are resolved.

United States

Worked on several studies on query management, manual review and data reconciliation.Performed quality control review on the studies by other data managers per QC guidelines.Planned all the assigned data review activities according to the priorities and met the timelines.Provided efficient support to the lead data managers by evaluating the priorities and timelines.Performed SAE Reconciliation and worked closely with the safety.Performed user acceptance testing of clinical database and edit checks.Performed clinical study data review as required by the DMP. Identifying incomplete, erroneous, and/or discrepant data and followed the DMP to address these discrepancies.Managed data discrepancy process to ensure discrepancies are generated and resolved in a satisfactory and timely manner and ensure the backlog is at minimal.Participated in study set-up, validation, and database lock activities for various studies.Generate CRF and query reports from EDC, review and provide the update to the lead data managers

United States

Manual query generation, discrepancy management, lab data reconciliation, tracking missing pages, freeze the clean CRF, etc.Ensuring completeness, accuracy, and internal consistency of all clinical data captured on EDC.Execute the data cleaning activities according to the DMP and protocol.Prepare study status based on the reports generated from the EDC and share with the managers.Participated in study set-up, validation of edit checks, dynamic rules, etc.Identify the trends of discrepancies in the studies and discuss with manager.Attend regular meetings conducted by the manager and actively participated by providing the progress of the studies.Tracked status and progress of data management for allocated projects/trials.Represented data management team and coordinated with internal/external teams to resolve the discrepancies.

Master'S Degree, Biotechnology

Bachelor'S Degree, Biochemistry

High School Diploma