United States or Canada (home-based)
Principal Clinical Data Manager
POSITION REPORTS TO:
Senior Manager, Clinical Data Management
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(s) in process improvements, issue escalation and training development and delivery. The position is responsible for acting independently to determine methods and procedures on new or special assignments and developing approaches to emerging industry trends. Support the department and company in achieving objectives and strategic goals.
AREAS OF RESPONSIBILITY:
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 the day-day work of the Data Management staff assigned to the project
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
Independently make decisions for questions contained to their assigned projects
Escalate concepts to the Manager that may impact or benefit the rest of the department or other studies
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
Lead the development, review and implementation of processes, policies, SOPs/WI’s and associated documents affecting DM
Lead the development of new concepts, technologies and products to meet emerging customer needs.
May participate in and/or lead DM and cross functional working groups
Applicants should have a minimum of an undergraduate degree and 3-5 years of progressive Clinical Data Management experience OR a college diploma and 5-8 years of progressive Clinical Data Management experience. CCDM designation is considered an asset.
- Accommodations for job applicants with disabilities are available upon request.