• Serves as Data Management Lead for Phase I - III studies.• Participates in management and oversite of trial CROs.• Designs, creates and implements test scrips to verify performance for clinical trials.• Creates internal edits to clean databases and verify the work being done by the contracted CRO.• Works with multiple cross functional groups for initiation, conduct and closure of clinical studies.• Performs listing review and creates and manages discrepancies for data which is incomplete, inconsistent or inaccurate. Evaluates query responses for appropriateness and issue closure.• Creates data management documentation required for the conduct of studies such as CRF specifications, DMPs, and DTA etc.• Participates in SOP creation and implementation associated with the VEEVA eTMF system.• Participates in the revisions of SOPs for process improvement initiatives.• Review reports of the key data using an internally developed SAS program.

• Draft internal edit checks for pediatric study.• Oversee query tracker exchanges with CRO’s, including reviewing query responses for appropriateness and confirmation of query closure.• Perform weekly extract using Omnicom EDC system and prep output for review.• Create work instructions for archival review and processes.• 100% review of submission required CRF casebooks.• Preformed UAT testing of EDC and IWRS systems, including creating test scripts for both EDC and IWRS.• Participated in study startups, conduct and preparation for closing.• Participated in DMP and Protocol reviews and CRF development.• Helped with archiving of DM Study Files.• Participated in training for ICH guidelines update as relates to sponsor oversite.

• Performed listing review and created queries for EDC system.• Helped to finish closing tasks to prepare a study for hard lock.• Compared raw data to CRF entries for accuracy• Read GCDMP guidelines for SCDM

• Performed QA for the CRF casebook for 12 DDI studies for submission to the FDA.• Assessed the quality of the CRF reproduction as well as the accuracy of bookmarks and hyperlinks.• Compared raw data to CRF entries for accuracy.• Participated in pre-lock review of documentation to prepare for hard lock.

• Reviewed documentation for quality in preparation for submission to the FDA for a multinational study.• Assessed the quality of the CRF reproduction as well as the accuracy of bookmarks and hyperlinks.• Compared raw data to CRF entries for accuracy.

Reviewed documentation for quality in preparation for submission to the FDA for a multinational study. Checked the placement of CRF’s in patient files. Assessed the quality of the CRF reproduction as well as the accuracy of bookmarks and hyperlinks. Compared raw data to CRF entries for accuracy.