Lead Data Manager – Clinical Trials

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

📋 Description

• Oversee all data management operations in large and intricate clinical studies with general supervision.

• Execute data management tasks for small to medium-sized projects with minimal supervision.

• Act as the main communication liaison for project teams and various company departments concerning clinical data management.

• Interact with clients and vendors regarding data management components and reporting.

• Manage EDC development, data collection, data cleaning, reconciliation, database locking, and the creation of the final integrated database, along with final data management deliverables.

• Review study documentation and either develop or assess data management plans and project-specific guidelines.

• Coordinate or conduct user acceptance testing.

• Create data validation plans and edit check specifications.

• Oversee and guide data entry processes while providing feedback on data quality.

• Conduct both automatic and manual data validation, review and resolve discrepancies, and generate and address queries.

• Manage non-CRF electronic data, including its receipt, archiving, loading, review, and reconciliation.

• Execute database edits and perform manual reviews of CRFs.

• Coordinate the clinical database locking process and manage CRF/query processing, dispatching, and archiving.

• Offer insights into the design of CRFs and data collection forms while reviewing CRFs for accuracy and adherence to protocols.

• Code medical data and evaluate coding dictionaries and listings as applicable.

• Conduct SAE reconciliation and review specifications for electronic data transfer.

• Collaborate with the Document Center concerning TMF and eTMF maintenance.

• Perform and document quality control checks for the database.

• Assist with internal, client, and third-party audits while resolving any findings related to Data Management audits.

• Train Assistant Data Managers and provide project-specific training for investigators and clinical teams.

• Prepare for and participate in investigator meetings, client/vendor meetings, and teleconferences.

⛳️ Requirements

• A college or university degree or an equivalent combination of training and experience that equips the candidate with the necessary knowledge, skills, and abilities.

• A minimum of 3 years of experience encompassing the full spectrum of data management duties in global EDC studies.

• At least 2 years of experience utilizing CDM/EDC systems.

• Experience with Medidata Rave or Oracle Inform is preferred.

• Project data management experience is advantageous.

• Strong organizational and managerial skills.

🏝️ Benefits

• Opportunity for remote work.

• Potential for career advancement.

• Chance to develop new skill sets.

• Opportunities for growth within the organization.