Manager, Clinical Data Management
New
P
ProKidneyClinical Data Management
RemoteFull-TimeManager
Salary not disclosed
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Job Details
- Experience
- 4-6 years of industry experience
- Required Skills
- Project ManagementMicrosoft Office
Requirements
- Undergraduate degree.
- 4-6 years of industry experience.
- Proven ability to meet strict deadlines and manage competing priorities.
- Strong organizational and time management skills.
- Good working knowledge of Microsoft Office (Word, Excel, PowerPoint) and web-based applications.
- Ability to work independently and on own initiative.
- Excellent attention to detail and accuracy.
- Excellent written and verbal communication and report writing skills.
- Strong project management skills.
- Knowledge of global standards related to clinical data management activities.
Responsibilities
- Represent DM as the functional lead at study team meetings, ensuring communication, collaboration, and overall data quality.
- Assume ownership for DM study deliverables including adherence to Study Plans, SOPs, and project timelines.
- Coordinate data reconciliation (e.g., Vendor, SAE) and resolve issues with functional areas and third-party vendors.
- Investigate and remediate data issues reported by statistical, safety, clinical, or medical reviewers.
- Coordinate with internal teams and CROs to develop and maintain DM startup timelines, including UAT and implementation of data capture tools.
- Manage post-production EDC modifications and team communications.
- Submit queries in the EDC and with the central laboratory.
- Develop, review, approve, and archive DM project documentation including CRFs, Data Management Plans, and edit check specifications.
- Ensure quality checks of clinical data and manage database lock, close-out audit, and archiving activities.
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