Lead Data Manager
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Job Description
Lead data manager overseeing clinical trial data from database startup through submission. Supporting UBC’s pharmaceutical development and real-world evidence services.
Responsibilities:
- Act as a lead data manager for one or more projects
- Act as primary contact with sponsors and communicate with management regarding study data management activities
- Manage data management activities from database start-up through database lock and CSR/submission
- Serve as the primary data management contact for internal, sponsor, and third-party vendor teams
- Deliver quality data to sponsors
- Review revenue recognition workbooks with Project Managers when DM tasks are completed
- Create and maintain Data Management Plans and core data management documents
- Provide input on study timelines, identify risks, and communicate mitigation strategies
- Coordinate data management deliverables and cross-functional study team activities
- Resolve data management issues during study conduct
- Design and develop database build specifications, CRFs/ePROs, visit/form configurations, and edit checks
- Develop data cleaning requirements and distribute data review tasks
- Coordinate and participate in user acceptance testing of study databases and external vendor systems
- Develop documents and support Real World Evidence projects
- Develop, track, analyze, and report data management performance metrics
- Adhere to project budgets and notify project teams about potential change orders
- Train and support project-specific data management staff
- Contribute to Data Management SOPs, work instructions, templates, standards, and regulatory best practices
- Participate in business development activities as required
- Perform other duties assigned by management
Requirements:
- BS/BA Degree or equivalency in clinical data experience
- Minimum 5 years clinical data management experience
- Leadership experience required
- Client-focused approach to work
- Experienced in all stages of clinical trials within Data Management is preferred
- Experience in late stage and real-world evidence projects a plus
- Understand Good Clinical Practices, Clinical research, Clinical Trial process and related regulatory requirements and terminology
- Familiarity with CDISC/CDASH including the SDTM model
- Excellent written, interpersonal, and verbal communication skills
- Work independently and report to the Manager of DM, as appropriate
- Critical thinking and problem-solving
- Willingness to travel up to 15%
Benefits:
- Remote opportunities
- Competitive salaries
- Growth opportunities for promotion
- 401K with company match*
- Tuition reimbursement
- Flexible work environment
- Discretionary PTO (Paid Time Off)
- Paid Holidays
- Employee assistance programs
- Medical, Dental, and vision coverage
- HSA/FSA
- Telemedicine (Virtual doctor appointments)
- Wellness program
- Adoption assistance
- Short term disability
- Long term disability
- Life insurance
- Discount programs
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