Senior Clinical Data Manager

This is a fully remote position, open to applicants in Canada.

📋 Description

• Lead, plan, and execute all data management activities for designated projects.

• Ensure the integrity, validity, and reliability of data in line with standard processes, sponsor guidelines, industry best practices, and regulatory requirements.

• Act as the primary contact for overseeing data management activities from study initiation through database lock.

• Develop data management plans and CRFs, create database specifications, test edit checks, and conduct data review processes.

• Coordinate database construction and testing with programming teams.

• Define and validate edit checks, manage data reviews, and handle query management.

• Process and reconcile electronic data from various sources, including CIMS, Safety databases, laboratories, and IRT.

• Coordinate and oversee a team of 1-7 Data Management staff members.

• Provide training, mentorship, and conduct performance evaluations.

• Manage project resources within defined budgets and timelines.

• Engage in and lead internal and sponsor meetings.

• Collaborate directly with project managers and teams, track study progress, issue status reports, and act as an escalation point for data-related issues.

• Develop and deliver training programs for investigators, clinical sites, project teams, and sponsors.

• Ensure that study documentation is maintained and securely stored in trial master files.

• Contribute to continuous improvement, information sharing, SOP/policy development, and cross-functional working groups.

• Serve as a Subject Matter Expert within the department.

• Support process enhancements and issue escalation.

• Foster data management excellence both internally and externally.

• Support departmental and organizational strategic objectives.

⛳️ Requirements

• A minimum of a one-to-two-year post-secondary certification in a relevant field of study.

• 4-6 years of relevant work experience in Clinical Data Management, complemented by ongoing training.

• Preferred specialty in Life Sciences or Clinical Research.

• CCDM (Certified Clinical Data Manager) certification is preferred.

• Ability to set a personal pace and prioritize tasks with a high degree of autonomy.

• Excellent interpersonal skills with patience and tact for managing regular interactions with team members, vendors, and clients.

• Resumes must be submitted in English.

🏝️ Benefits

• Education Reimbursement program available for full-time employees.

• Monthly Cell Phone and Remote Work Allowance (based on role eligibility).

• One-time office setup allowance (can be used for purchasing a scanner/printer, extra monitor, office furniture, etc.).

• Working while visiting program – up to 4 weeks per year!

• Flexible Summer Hours Program from May to September.

• Employee referral incentive.

• Full-time employees become beneficiaries of the Alimentiv Trust after one year of employment, and permanent members after five years of employment.

• Optional formal mentorship program (Alimentorship).

• Country/region annual social events in person.

• Leadership development programs for people leaders tailored to your seniority.

• Social committee and several other optional initiatives designed to help you feel 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.

• Remote work allowance.