Data Manager – Clinical Trials

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

📋 Description

• Serves as a communication liaison for project teams concerning clinical data management.

• Oversees the maintenance of TMF/eTMF.

• Provides training for the Assistant Data Manager.

• Engages in clinical data management tasks, which include but are not limited to: assisting in the development of study documentation (eCRF Requirements, Edit Checks Specification, Data Management Plan, CRF Completion Guidelines, User Access Management Plan, Data Validation Plan, External Data Transfer Agreements, SAE Reconciliation Guidelines, Local Lab Normal Ranges Guidelines, and Coding Guidelines when applicable).

• Conducts user acceptance testing.

• Manages user access.

• Performs data review and reconciliation of eCRF/External data.

• Involves in medical coding (for individuals with a medical/Life Science background).

• Aids in SAE reconciliation.

• Handles query management.

• Inputs and conducts quality control on local lab normal ranges.

• Participates in Study Database Lock activities.

• Archives CRFs.

• Conducts quality control on data entry.

• Reports project status.

• Generates and delivers data listings/patient profiles.

• Assists with Database Lock tasks as required for assigned projects.

⛳️ Requirements

• Possesses a college or university degree or an equivalent blend of training and experience that demonstrates the necessary knowledge, skills, and abilities.

• At least one year of industry experience, preferably in clinical or medical data.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health and wellness benefits.

• Opportunities for professional development and career advancement.

• Supportive and inclusive work environment.