Lead Data Manager – Clinical Trials

PSI CRO AG

. Manage all data management activities in large, complex clinical studies under general supervision .

Posted 9/23/2026full-timeRemote • CanadaSenior💰 CA$130,000 - CA$150,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in managing data management activities for clinical studies, including EDC development, data validation, and quality control. Proficient in coordinating project teams and ensuring compliance with data management standards.

Highest-signal resume keywords

Data Management ExperienceEDC Systems ProficiencyMedidata Rave ExperienceOracle Inform ExperienceOrganizational Skills

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Data ValidationDatabase Lock CoordinationCRF ReviewData CleaningDiscrepancy ResolutionUser Acceptance TestingData Management Plans DevelopmentMedical Data CodingAudit SupportQuality-Control Checks

Soft Skills

Communication SkillsManagerial SkillsTraining Skills

Tools & Technologies

CDM SystemsEDC SystemsMedidata RaveOracle Inform

Industry Keywords

Clinical StudiesData ManagementElectronic Data CaptureTMF MaintenanceSAE Reconciliation

Tech Stack

Tools & technologies

Oracle

About the role

Key responsibilities & impact

Manage all data management activities in large, complex clinical studies under general supervision
Perform data management activities for small to medium-sized projects under minimal supervision
Serve as the primary communication point for project teams and company departments regarding clinical data management
Communicate with clients and vendors regarding data management aspects and reporting
Coordinate EDC development, data collection, cleaning, reconciliation, database lock, final integrated database development, and final data management deliverables
Review study documents and develop or review data management plans and project-specific guidelines
Coordinate or perform user acceptance testing
Develop data validation plans and edit check specifications
Coordinate and supervise data entry and provide feedback on data quality
Perform automatic and manual data validation, discrepancy review and resolution, and query generation and resolution
Handle non-CRF electronic data, including receiving, archiving, loading, review, and reconciliation
Perform database edits and manual CRF review
Coordinate clinical database lock and CRF/query processing, dispatch, and archiving
Provide input into CRF and data collection form design and review CRFs for accuracy and protocol adherence
Code medical data and review coding dictionaries and listings where applicable
Perform SAE reconciliation and review electronic data transfer specifications
Liaise with the Document Center regarding TMF and eTMF maintenance
Perform and document database quality-control checks
Support internal, client, and third-party audits and resolve Data Management audit findings
Train Assistant Data Managers and provide project-specific training to investigators and clinical teams
Prepare for and attend investigator meetings, client/vendor meetings, and teleconferences

Requirements

What you’ll need

College or University degree or equivalent combination of training and experience that presents the required knowledge, skills and abilities
At least 3 years of experience with the full scope of data management responsibilities in global EDC studies
At least 2 years of experience using CDM/EDC systems
Medidata Rave or Oracle Inform experience preferable
Project data management experience is a plus
Organizational and managerial skills

Benefits

Comp & perks

Remote work available
Career advancement opportunities
Opportunity to develop new skillsets
Growth within the organization