Job Description

Accountabilities:

• Serve as the primary contact for data management timelines, deliverables, out-of-scope requests, and technical or procedural matters across assigned projects.
• Perform and oversee hands-on clinical data management activities, including database design specifications, UAT test plans, data transfer specifications, and related quality reviews and approvals.
• Review clinical and external data, identify discrepancies, issue and resolve queries, and support sponsors, investigative sites, and other clinical research partners in query resolution.
• Manage third-party and non-Case Report Form data management activities and ensure accurate integration into clinical data workflows.
• Plan, coordinate, and execute data processing and management activities while ensuring compliance with sponsor requirements, timelines, standard operating procedures, and applicable quality standards.
• Validate electronically captured data and lead the creation of clear, accurate queries for missing data, range-check failures, and logical inconsistencies.
• Validate and distribute real-time study monitoring reports to sponsors and internal project teams.
• Review and develop database edit checks and contribute to standardized validation checks for common and therapeutic-area-specific modules.
• Train clinical trial personnel and study teams on electronic data capture systems, data flows, data entry, review processes, and quality control procedures.
• Participate in project kickoffs, investigator meetings, and regular project management meetings, providing data management expertise and guidance.
• Manage study-level resources, review team timesheets, monitor project milestones, and proactively address risks to timelines and deliverables.
• Manage post-go-live database modifications resulting from protocol amendments or evolving study requirements.
• Develop, maintain, and document the Data Management Plan, including deviations and related decisions.
• Develop and maintain Data Quality Review Plans and coordinate with programmers on the creation and validation of required listings and summary tables.
• Support project bids, billing activities, out-of-scope task tracking, and bid defense meetings.
• Promote effective project management practices and contribute to departmental improvement initiatives, clinical data standards, training standards, and technology enhancements.
• Monitor regulatory requirements, industry trends, benchmarks, and emerging best practices relevant to clinical data management.
• Support quality assurance audits and ensure complete preparation and archival of data management documentation for assigned clinical trials.

Requirements:

• Bachelor’s or Master’s degree in a relevant scientific, healthcare, or technical field.
• At least 10 years of relevant clinical data management experience.
• In-depth knowledge of clinical trial data management concepts, processes, procedures, and data flows.
• Strong understanding of pharmaceutical clinical trial regulations, industry guidance, conventions, and applicable data management standards.
• Demonstrated ability to lead clinical trial data management activities and integrate them effectively with broader clinical trial operations.
• Strong experience with clinical data review, database management, validation, quality control, data transfer, and electronic data capture processes.
• Excellent written and verbal communication skills, with the ability to work effectively with stakeholders at all professional and organizational levels.
• Strong presentation and relationship-building skills, particularly when working with sponsors, investigators, study teams, and other external stakeholders.
• Highly organized with the ability to independently manage multiple projects, priorities, deadlines, and deliverables.
• Strong analytical and information-processing skills, with a consistent focus on data accuracy and quality.
• Demonstrated leadership, collaboration, and problem-solving capabilities.
• Ability to identify issues proactively, communicate risks clearly, and drive appropriate resolutions.
• Commitment to maintaining current knowledge of regulatory developments, industry trends, and evolving clinical data management practices.

Benefits:

• Estimated salary range of $130,000–$165,000
• Medical, dental, and vision coverage.
• Life and AD&D insurance.
• Short- and long-term disability coverage.
• Pension plan.
• Generous paid time off and sick leave.
• Tuition reimbursement.
• Fitness reimbursement.
• Employee Assistance Program (EAP).
• Performance-based bonus opportunity.
• Remote work opportunity from a home-based office in Canada.
• Opportunities for professional development, training, and continued growth.
• Inclusive workplace with accommodations available throughout the recruitment and selection process.