Job Description

• Leads all clinical data management activities for assigned clinical studies assuring all timelines are met with best quality.
• Responsible for overseeing creation and approval of DM study documentation by vendors/CROs (i.e. CRFs, completion guidelines, database specs, edit checks, data review plans, data transfer specifications, SAE reconciliation plans, and external vendor data reconciliation plans).
• Reviews clinical data and metrics to identify data quality trends, compliance with the protocol, consistency of data across subjects and sites and potential risks to timelines.
• Reviews the deliverables of DM vendors to ensure accuracy and consistency with expected practices.
• Coordinates cross-functional data review meetings with the clinical team. Manage the collection of data issues, reporting of findings and communication of post-review status.
• Produces regular data listings for the clinical team and other functional areas.

• 5+ years of clinical data management experience in pharmaceutical industry as a Lead CDM at a small-midsized pharmaceutical company; BS degree.
• Experience leading all DM functions for clinical studies including global studies including but not limited to.
• data management plans, edit specifications, utilizing data dictionaries, electronic data transfers, data quality reviews and reporting.
• Expertise with Medidata RAVE and other databases such as IVRS/IWRS, Central Imaging etc.
• Knowledge of SDTM & CDISC.
• Need to be comfortable wearing multiple hats and working hands on to support any in-house DM work as required.

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