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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.
Requirements:
5 years of experience as a Lead CDM at a small-midsized pharma/biotech 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.
Seniority level
Associate
Employment type
Contract
Job function
Information Technology
Industries
Pharmaceutical Manufacturing
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