Support DM-related activities, collaborate with Lead DMs, and review clinical data to ensure accuracy, consistency, integrity, and completeness.
Requirements
- Provide regular updates to Lead DM on progress, timelines, risks, and quality
- Track tasks against budget and forecasts; identify and initiate scope change requests when required
- Develop, review, and maintain key DM documents such as DMP, eCRF specifications, DVP, and external data transfer agreements
- Support or lead clinical database setup, including eCRF design and validation requirements
- Participate in reviewing study documents like protocols, project plans, safety plans, and statistical analysis plans
- Coordinate and complete User Acceptance Testing (UAT) activities for databases
- Create training materials and provide EDC training for study teams
- Review and validate clinical data to ensure accuracy, consistency, integrity, and completeness
- Support data cleaning strategies and assist in data releases (interim, final locks, and post-lock updates)
- Perform and coordinate data transfers and reconciliation activities (SAE, PK, lab data, etc.)
- Prepare and review project metrics and status reports, highlighting site performance, data trends, and protocol deviations
- Support and conduct Quality Review activities; may also lead these when required
- Support or manage database maintenance, lock, and close-out activities
- Participate in meetings with vendors and sponsors as needed
- Identify issues, solve problems, and assess effectiveness of solutions
- Maintain up-to-date DM documentation and ensure proper filing throughout the study
- Prepare documentation for audits and participate in internal/external audits when assigned
- Support alignment of data management and clinical programming standards and best practices
- Contribute to process improvement initiatives to enhance efficiency
Benefits
- Comprehensive benefits package
- Competitive salaries
- Departmental Study/Training Budget
- Flexible Working hours
- Opportunity for remote/hybrid working
- Leadership and mentoring opportunities
- Buddy Program
- Internal growth opportunities and career progression
- Financially rewarding internal employee referral program
- Access to online soft-skills and technical training
- Eligibility for Spot Bonus Award Program
- Eligibility for Loyalty Award Program