Clinical Data Manager - Katalyst Healthcares & Life Sciences
Cambridge, MA 02138
About the Job
Responsibilities:
- 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.
Source : Katalyst Healthcares & Life Sciences