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Job Description & How to Apply Below
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
- 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
- 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
- Dental care
- Extended health care
- Life insurance
- Paid time off
- Vision care
Position Requirements
5+ Years
work experience
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