Puzzle Medical Devices is seeking a Senior Clinical Data Manager to join the Clinical team. This role owns clinical data management activities across the company's clinical studies, including electronic data capture (EDC) system setup and administration, case report form (CRF) design support, data cleaning and quality control, and the preparation of data listings, summaries, and reports for internal stakeholders and regulatory submissions.

Responsibilities

Clinical Data Management & EDC

• Lead end-to-end clinical data management for assigned studies, from database build through database lock, in accordance with the study's Data Management Plan (DMP).

• Build, configure, test, and maintain the Electronic Data Capture (EDC) system, including edit checks, user access, and version control across study amendments.

• Own the accuracy, completeness, and timeliness of data entered into the EDC across all active studies.

• Develop and maintain data validation rules, run data quality checks, and manage query resolution with clinical sites.

• Perform data reconciliation across source systems (e.g., EDC, safety database, central lab) and support serious adverse event (SAE) reconciliation.

• Draft and maintain data management documentation, including the DMP, CRF completion guidelines, and data transfer specifications.

• Support database lock activities and archival of the clinical database at study close-out.

CRF Design & Data Quality

• Collaborate with Clinical Operations and Biostatistics on the design, review, and revision of Case Report Forms (CRFs), ensuring alignment with the protocol and statistical analysis plan.

• Contribute to process improvement and standardization of data management practices across studies.

Reporting & Governance Meeting Support

• Prepare data listings, tables, and summary reports to support internal review, data monitoring committees, and regulatory submissions.

• Create presentation materials (e.g., PowerPoint) and present clinical data at key governance meetings, such as the Data Safety Monitoring Board (DSMB), Clinical Events Committee (CEC) etc.

• Write and contribute to clinical reports, including data summaries, safety narratives, and study-milestone reports, ensuring content is accurate and audit-ready for internal and regulatory review.

• Work with clinical sites to collect patient data on an urgent, time-sensitive basis to support Case Review Board decisions during patient screening and throughout therapy follow-up.

Site Management & Communication

• Maintain close, ongoing communication with site staff to drive timely and complete data entry, following up firmly and consistently while maintaining strong, collaborative site relationships.

• Train site staff on EDC use and data entry requirements, and remain available to sites as an ongoing point of contact for data-entry questions.

• Confirm with sites that all patients are scheduled for every required follow-up visit, and proactively identify and resolve any missing or at-risk follow-ups.

Vendor & Site Payment Oversight

• Manage relationships with third-party data management and other clinical vendors, overseeing deliverables, timelines, and contract compliance.

• Coordinate site payments and verify, prior to release, that all required data for the applicable visit or milestone has been entered and is available in the database.

Quality & Compliance

• Own data management records in accordance with Puzzle's Quality Management System (QMS) and applicable regulatory requirements.

Qualitifcation & Experience

• 5 years of progressive experience in clinical data management within the medical device, pharmaceutical, or biotech industry.

• Hands-on experience configuring and administering at least two major EDC platforms.

• Demonstrated experience with CRF design and query/data cleaning processes.

• Preferred experience with cardiovascular or other high-risk implantable device clinical studies.

• Familiarity with statistical software (e.g., SAS, R) for exploratory data review.

• Experience working within an ISO 13485 / FDA QMSR-regulated quality system.

Knowledge and skills

• Bachelor's degree in life sciences, health informatics, statistics, or a related field; advanced degree an asset.

• Working knowledge of Good Clinical Practice (GCP), clinical data management standards (e.g., CDISC/CDASH), and applicable regulatory frameworks for medical device trials.

• Strong analytical skills with the ability to produce clear data summaries and written reports for technical and non-technical audiences.

• Excellent written and verbal communication skills in English and French.

• Highly organized, detail-oriented, and comfortable working in a fast-paced, growing startup environment.

Work conditions

This is an office-based role at Puzzle Medical Devices' Montreal facility, with occasional travel to clinical sites as needed. Standard business hours apply, with flexibility to accommodate study milestones (e.g., database lock).

At Puzzle, we value our employees and offer a comprehensive benefits package

• Comprehensive group benefits including medical, dental, and vision coverage;

• Virtual healthcare access for you and your immediate family (Dialogue);

• 2 sick days + 3 personal days to support your work-life balance;

• 50% reimbursement on gym memberships to support your well-being;

• 3 weeks of vacation + Paid holiday closure in December so you can fully enjoy the festive season;

• Employee referral bonus program;

• Free coffee to keep you energized;

• Regular team activities and social events to foster a collaborative and fun work environment.