Sr. Clinical Data Manager

Project Support

• • Serve as the Lead Data Manager and primary contact responsible for overseeing day-to-day data management activities from study start-up through final database lock, including, but not limited to:
  • Creation and maintenance of the Data Management Plan
  • Development and design of Case Report Forms (CRFs)
  • Develop Database Build specifications and coordinate database build and testing activities with database programmers
  • Define and test edit checks
  • Perform data review and query generation/resolution
  • Track study progress and issue periodic status reports
  • Process/reconcile electronic data received from other data sources, e.g. CIMS, Safety database, labs, IRT
  • Oversee database lock and transfer process.
  • Coordinate and supervise the day-day work of Data Management (DM) staff assigned.
  • Train and mentor assigned employees on data management procedures and guidelines.
  • Participate/lead internal/sponsor meetings as required, working directly with the assigned project manager and team to provide data management support.
  • Ensure approved study documentation is maintained and properly stored in the trial master files.
  • Manage project resources per budget and within expected timeframes.
  • Develop or assist with the project training development and delivery, for investigators, clinical sites, project teams and sponsors on data collection processes, tools and/or equipment as required.
  • Act as point of escalation for data related issues and queries.

Department Support

• • Contribute to the continuous improvement of DM and the wider organization through information sharing, training and education.
  • Promote and be an advocate of DM internally and externally.
  • Coach, mentor and/or train peers, contribute to peer selection, performance evaluation, peer orientation and project communications.
  • May participate in and/or lead the development, review and implementation of processes, policies, SOPs/WI’s and associated documents affecting DM.
  • May participate in and/or lead DM and cross functional working groups.
  • May supervise Data Management staff.

QUALIFICATIONS

• • Applicants should have a minimum of a one to two year post-secondary certification in a relevant field of study, and 3-5 years of related work experience in Clinical Data Management with ongoing training. CCDM designation is considered an asset.

WORKING CONDITIONS

•  Home-based