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Manager, Clinical Data Management

Remote

ProKidney is seeking a Manager, Clinical Data Management. In this role, you will own data management study deliverables end-to-end — from data capture tool development through database lock — while partnering closely with CROs and third-party vendors to keep clinical data accurate, timely, and audit-ready. This is an excellent opportunity for an experienced data management professional to take ownership of study-level DM operations and drive quality and consistency across our clinical program.

Primary Responsibilities and Job Functions

  • 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

Minimum Requirements

Must have undergraduate degree and 4-6 years of industry experience

Skills/Abilities:

  • 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

ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

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