Work within Clinical Affairs teams to manage and ensure integrity of clinical study data from start-up through close-out and database lock. Served as Sr. Lead Principal Data Manager role on multiple clinical studies and projects. Key responsibilities include, but are not limited to:• Review clinical investigation protocols and other clinical research documents for identification of data collection needs and compliance with applicable regulations.• Establish project timelines and responsibilities, track project status, and communicate progress related to Data Management activities to all cross-study functions and stake holders. • Develop, implement, and maintain clinical study database requirements for IDE, 510(k), and post-marketing studies. Including case report form (CRF) design, data validity check specifications, and other study specific functionalities.• Develop clinical study database test plans, summary reports, and other related documentation. Coordinate and conduct user acceptance testing (UAT) and database validation within established timelines.• Develop, implement, and maintain Clinical Data Management plans, CRF completion guidelines, data handling guidelines and other study support documentation.• Provide electronic data capture (EDC) user system administration, ensuring consistent processes and appropriate training documentation.• Develop, implement, and maintain data listings, summary tables, and report specifications for conducting review/QC of clinical trial data; write/resolve queries and track the status of data for data cleaning, data review activities and study metrics. • Reconcile clinical study data with external data sources and liaise with Safety team and/or Lab vendors and perform/oversee External data reconciliation and SAE reconciliation.• Facilitate data transfers for statistical reporting and other clinical reporting activities.• Coordinate close-out and archival of study databases and related documents.

•Provided DM responsibilities (Discrepancy Management, DCF creation, DCF entry and QC). •Communicated w/ the clients and management regarding study issues and updates. •Followed study specific and global conventions. Participated in company growth & development by assisting with interviewing potential candidates, assisted in training new employees, participated in multiple focus groups including annual SOP review board, EDC focus group, and Engagement committee/Marketing focus group.•Created/Prepared Data Management Plan (DMP), Edit Check Specifications, and CRF Completion Guidelines.•Performed database UAT to ensure it is ready for entry and also that the validations are functioning properly. Including creating and entering test data for UAT on database and edit checks prior to activation providing feedback to database team.•Performed manual review of casebooks to verify the edit checks are working properly and to identify data discrepancies outside of the Edit Check Specifications.•Compiled and maintained all study documentation.•Performed steps on Release, Freeze and Lock checklist and coordinated all activities pertaining to these functions.•Performed DCF creation, printing, and distributing; reviewed DCFs created by other Clinical Data Managers.• Tracked all Data Management issues and ensured resolution by study completion.•Identified areas of difficulty within study modules developing and implementing an action plan. •Maintained constant effective communication with all clients ensuring proficient study flow.•Acted as lead Clinical Data Manager on several studies using PhaseForward/Inform Electronic Data Capture (EDC) tool.•Acted as the lead Data Manager on studies and performed all activities from study start up to study completion.•Supported another lead Data Manager for studies by performing Discrepancy Management, Quality Control checks and DCF entry to Study completion.•Used Medidata Rave, Viedoc and iMednet EDC systems on several client studies.

Clinical Data Manager• Worked with Medical Team on protocol amendment to reach clinical trials goals.• Interacted/communicated in matrix organization including Data Management, Medical, Data Operations, Statistics, programming and International Ventures.• Was responsible for review and implementation of all information of investigator meetings.• Performed data management task such as data tracking, querying, SAE reconciliation, laboratory reconciliation, data base maintenance and data quality assurance and control. • Working knowledge of GCP, FDA, ICH, CDC and PhRMA guidelines.• Developed, designed, and queried discrepancies on CRFs.• Was responsible for clinical trials, database (SCHEMA) design, and adherence to protocol and clinical data management from study start to database lock.• Use of SAS (UNIX), Nomad (VM), Lotus, Excel, Oracle clinical and other clinical data management tools.• Selected to laboratory data review and authorization team.• Attended CRA clinical monitoring meetings.Clinical Data Manager (CDM)• Reached clinical trial goals for Pharmaceutical Clinical Research Division working closely with medical team on protocol amendment. • Maintained constructive relationships with data management/operations, medical, statistics, programming and International Venture departments. • Developed, designed and queried CRFs, performed data management tasks, and monitored quality control measures. Specific responsibilities included: Recognize and explain AEs and SAEs to investigators to maintain compliance with study protocol. Some safety review and medical coding.• Designed and implemented effective research strategy plans• Trained and managed research and administrative staff• Performed data tracking, querying, SAE and laboratory reconciliation• Implemented and reviewed information from investigator meetings• Working knowledge of GCP, FDA, ICH, CDC and PhRMA guidelines• Use of SAS (UNIX), Nomad (VM), Lotus, Excel, Oracle clinical, EDC.