Sr. Clinical Data Manager

Job Overview

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.

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.

Skills & Qualifications

• A minimum of a one-to-two-year post-secondary certification in a relevant field of study, and 4-6 years of related work experience in Clinical Data Management with ongoing training.

• Life Sciences or Clinical Research specialty and 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

What We Offer

In addition, as an Alimentiv Employee, you’re also eligible for the following programs:

• Education Reimbursement program for full-time employees
• Monthly Cell Phone and Remote Work Allowance (dependent on role eligibility)
• One time office setup allowance (can be used to purchase a scanner/printer, extra monitor, office furniture, etc.)
• Working while visiting program - up to 4 weeks per year!
• Flexible Summer Hours Program from May - September
• Employee referral incentive - we know great people know other great people, and we think that warrants recognition!
• Full-time employees also become beneficiaries of the Alimentiv Trust after one year of employment, and permanent members after 5 years of employment
• Optional formal mentorship program (Alimentorship); country/region annual social events in person; leadership development programs for people leaders in accordance with your seniority; social committee and several other optional initiatives designed to support you in feeling like part of the Alimentiv team!

Additional benefits may be available depending on the country of employment and are subject to local policies and eligibility.

Our Services

• End-to-end GI clinical trial services, from protocol design through submission support
• Central medical imaging management and endoscopic reading
• Precision medicine and biomarker solutions
• Real-world evidence and clinical consulting
• Histopathology and lab services through AcelaBio

How to Apply

To apply for this position, please submit your resume through the Alimentiv Careers Portal or via LinkedIn’s Easy Apply. Resumes must be submitted in English.

Equal Opportunity and Accessibility

Alimentiv is committed to building a diverse, inclusive and respectful workplace. We are an equal opportunity employer and consider all qualified applicants for employment without regard to race, colour, ethnicity, national origin, religion or belief, sex, gender identity or expression, sexual orientation, age, marital or family status, disability, or any other characteristic protected by applicable law.

Accommodations are available upon request for persons with disabilities throughout the recruitment and selection process. Requests can be directed to [email protected].