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 recommending 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, or Pharmaceuticals
- Working knowledge of clinical, medical, and biology domains
- Proficiency in Microsoft Word, Excel, PowerPoint, Project, and Outlook
- Knowledge of ICH-GCP
- Experience with EDC systems (data entry and/or configuration)
- Enthusiastic, smart, resourceful, analytical
- Well‑developed written and communication skills
- Perceptive listening skills
- Strong 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
- or recognized equivalent in a Health or Science related field
Benefits
- Dental care
- Extended health care
- Life insurance
- Paid time off
- Vision care
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运动公司 Data Manager in Richmond Hill employer: Intscanada
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