Clinical Data Manager H/F

  • Lyon
  • Ividata Life Sciences

Missions:

Key contact for client Data Management for any study responsible, ensure projects meet study timelines. Represent Data Management at Study Team meetings/client meetings

Support EDC database build and testing through go live

Drive, organise, monitors and track ongoing data cleaning, data review, discrepancy management and data extractions for review committees, interims and database lock

Support eCRF design using CDASH and programming of SDTM output where required

Write, review and approve study Data Management documents using agreed templates per Ividata Group

Manage external data including preparation of Data Transfer agreements, data reconciliation, loading, secure storage and archiving per client requirements

Review and generate study metrics and status reports within and across several studies

Vendor management and oversight of client service providers DM activities

Profile :

Higher education (BSc, MSc, PhD in life sciences or technical)

At least one year DM experience for Data Manager, 3+ years for lead Data Manager

Proficient in one of the leading Data Management systems: Veeva CDMS, Medidata RAVE, Oracle

Good level of English (written and oral)

Soft skills: Autonomy, teamwork, interpersonal skills and leadership