JOB SUMMARY:
Responsible for leading, planning and execution of all data management activities for assigned projects, ensuring focus on data integrity, validity, reliability in accordance with standard processes, sponsor guidelines, industry best practices and regulatory standards. Act as coach, mentor and/or Subject Matter Expert within the department, aiding Manager in process improvements, issue escalation and training development and delivery. Support the department and company in achieving objectives and strategic goals.
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.
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Last updated on Feb 27, 2024