This is a full-time Data Manager position.

Candidates should have 3-5 years’ prior experience working in Data Management at a CRO/Biotech/Pharmaceuticals. Candidates who do not meet this criterion will not be considered for this role.

The Data Manager is responsible for Data management activities for one or more clinical trial or registry projects, working closely with the Project Manager and the other members of each team.

Responsibilities

RESPONSIBILITIES RELATED TO PROJECT INITIATION

Effective management of all data and reports (management reports and/or clinical data reports) based on project protocol and overall information objectives

Assist with implementation and testing of eCRF and reports into Axiom Aware or Axiom Go Cubed Data Capture & Reporting Tools

Develop key Data Management documents for presentation to and review by the sponsor

Assist where applicable in the development and implementation of site training and ongoing data management related support plans

RESPONSIBILITIES RELATED TO PROJECT MAINTENANCE

Responsibility for all aspects of data management for each study, including issue and resolution of queries where applicable

Responsible for ensuring data integrity, the performance of edit checks, and recommends applicable changes/updates to the Data Integrity Plan as per Sponsor request/Protocol amendments and/or eCRF updates

Follow up on eCRF and query completion with sites

Evaluate and add queries to data where applicable based on edit check output

Responsible for data transfer configuration and quality assurance of data transfer validation activities

Remote site training, support,



and communications from a data management perspective

Ongoing support for the management of the project and associated ancillary initiatives (e.g. newsletters, data abstracts/manuscripts/presentations, public awareness activities, project expansion, assisting with interim analyses, database lock and coding, etc)

Assist, where applicable, with the maintenance of the Axiom Aware or Axiom Go Cubed Clinical Trial Suite application in conjunction with the Project Manager

RESPONSIBILITIES THROUGHOUT LIFECYCLE OF A PROJECT

Data management and data quality assurance

Close, ongoing collaboration with members of the project team to ensure the project runs smoothly and efficiently and that overall strategic objectives are realized

Qualifications

3-5 years experience in CRO/ Biotech/ Pharmaceuticals

Working knowledge of clinical/medical/biology

Proficiency in Microsoft Word, Excel, PowerPoint, Project, and Outlook

or recognized equivalent in Health or Science related field

Knowledge of ICH-GCP

Experience with EDC systems (data entry and/or configuration)

Proficiency in Microsoft Word, Excel, PowerPoint, Project, and Outlook

Enthusiastic, smart, resourceful, analytical

Proven to take

Well-developed written and communication skills

Perceptive listening skills

Robust attention to detail

Time management skills

Ability to work independently within a team environment

Adept at multi-tasking

Basic understanding of web-based technologies and browsers

Benefits

Dental care

Extended health care

Life insurance

Paid time off

Vision care

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📌 科技公司 Data Manager (Ontario)
🏢 Intscanada
📍 Ontario