Note: The job is a remote job and is open to candidates in USA. ProKidney Corp. is seeking a Manager, Clinical Data Management to oversee data management study deliverables from data capture tool development through database lock. This role involves collaborating with CROs and third-party vendors to ensure the accuracy and quality of clinical data.
Responsibilities
- Represent DM as the functional lead at study team meetings; responsible for communication and collaboration, assuring overall quality of study data
- Assumes ownership for DM study deliverables within DM scope of services including overseeing overall quality, adherence to Study Plans and standard operating procedures & creation and management of DM-specific timelines
- Data Reconciliation (e.g., Vendor, SAE) including coordination of transfers and issue resolution with other functional areas and/or 3rd party vendors
- Investigation and remediation of reviewer-reported data issues such as from statistical, safety, clinical or medical reviews
- Coordinates with ProKidney, CRO and other 3rd party vendors to develop and maintain DM startup timelines including the development, UAT testing and implementation of all data capture tools
- Coordinates with ProKidney, CRO and other 3rd party vendors to manage post-production EDC modifications assuring effective implementation (including consistency across program when applicable) and team communication for program and/or projects
- Responsible for submitting queries in the EDC and with the central laboratory
- Develops, Maintains, Reviews, Approves and Archives DM Project Documentation including: Case report forms, edit check specifications, Data Management Plan, Data Review Plan, CRF Completion Guidelines, and other study-specific plans as required
- Data review listing specifications and data transfer specifications
- Ensure quality check of clinical data as appropriate for statistical review, interim review, and or final database lock. Responsible for database lock, close-out audit and archiving activities
- Manage and store data transfers from 3rd party vendors
- Development and management of patient profiles for clinical review and data cleaning
Skills
- Undergraduate degree
- 4-6 years of industry experience
- Proven ability to meet strict deadlines
- Manage competing priorities and ability to be flexible and receptive to changing demands
- Excellent organizational skills and time management skills
- Good working knowledge of Microsoft Office and web-based applications (e.g., Word, Excel, Powerpoint)
- Proven ability to follow instructions/guidelines, work independently and on own initiative
- Excellent attention to detail and accuracy maintaining consistently high-quality standards
- Excellent written/verbal communication and report writing skills
- Sound judgment, independent thinking, and decision-making skills
- Self-motivated and flexible
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
- Good understanding of operational metrics, productivity and initiatives
- Demonstrate effective project management skills
- Knowledge of global standards related to clinical data management activities
- Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship
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