Sr. Clinical Data Manager
Alimentiv
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.
Job description
Key Responsibilities
- Lead Data Management Operations: Serve as primary contact overseeing all data management activities from study start-up through database lock, including data management plan creation, CRF development, database specifications, edit check testing, and data review processes.
- Database Development & Quality Control: Coordinate database build and testing with programmers, define and validate edit checks, perform data review and query management, and process/reconcile electronic data from multiple sources (CIMS, Safety database, labs, IRT).
- Team Leadership & Supervision: Coordinate and supervise 1-7 Data Management staff members, providing training, mentorship, and conducting performance reviews while managing project resources within budget and timelines.
- Stakeholder Communication & Project Coordination: Participate in and lead internal/sponsor meetings, work directly with project managers and teams, track study progress, issue status reports, and serve as escalation point for data-related issues.
- Training & Documentation Management: Develop and deliver training programs for investigators, clinical sites, project teams and sponsors on data collection processes and tools; ensure study documentation is maintained and properly stored in trial master files.
- Department Development & Process Improvement: Contribute to continuous improvement through information sharing, coach and mentor peers, participate in or lead development of SOPs/policies, and support cross-functional working groups.
- Strategic Support & Advocacy: Act as Subject Matter Expert within the department, support manager with process improvements and issue escalation, and promote data management excellence internally and externally.
- Compliance & Standards: Ensure all activities adhere to standard processes, sponsor guidelines, industry best practices, and regulatory standards while supporting departmental and company strategic goals.
Requirements
- A minimum of a one-to-two-year post-secondary certification in a relevant field of study
- 4-6 years of related work experience in Clinical Data Management with ongoing training
- Life Sciences or Clinical Research specialty preferred
- CCDM (Certified Clinical Data Manager) certification preferred
- Ability to set personal pace and prioritize tasks with significant autonomy
- Strong interpersonal skills with patience and tact for managing regular contacts with team members, vendors, and clients
Benefits
- Education Reimbursement
- Cell Phone Allowance
- Remote Work Allowance
- Office Setup Allowance
- Working While Visiting Program
- Flexible Summer Hours
- Employee Referral Incentive
- Alimentiv Trust Beneficiary
- Mentorship Program
- Leadership Development Programs
Company overview
Alimentiv is a leading specialty gastrointestinal (GI) contract research organization (CRO) founded in 1986 and headquartered in London, Ontario, Canada. The company operates as a full-service CRO specializing in GI clinical trials, with deep expertise in inflammatory bowel disease (IBD), eosinophilic gastrointestinal diseases (EGIDs), celiac disease, and other GI disorders. Alimentiv provides comprehensive clinical research services including clinical trial management, medical monitoring, medical imaging solutions, precision medicine/biomarker services, histopathology, biostatistics, and real-world evidence generation. The company supports over 70% of all IBD compounds currently in development and maintains a global network of 5,000+ clinical trial sites across more than 60 countries. With approximately 501-1,000 employees and offices in Canada, the United States, Europe, and Australia, Alimentiv combines academic excellence with operational expertise to accelerate drug development timelines and improve clinical trial outcomes for pharmaceutical and biotechnology partners.