Wait, What Do You Do?

<p></p> <p class="font-claude-response-body break-words whitespace-normal" data-sourcepos="8:1-8:568;161-728">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.</p> <h2 class="text-text-100 mt-3 -mb-1 text-[1.125rem] font-bold" data-sourcepos="10:1-10:46;730-775">Primary Responsibilities and Job Functions</h2> <ul class="[li_&]:mb-0 [li_&]:mt-1 [li_&]:gap-1 [&:not(:last-child)_ul]:pb-1 [&:not(:last-child)_ol]:pb-1 list-disc flex flex-col gap-1 pl-8 mb-3" data-sourcepos="12:1-24:87;777-2606"> <li class="font-claude-response-body whitespace-normal break-words pl-2" data-sourcepos="12:1-12:150;777-926">Represent DM as the functional lead at study team meetings; responsible for communication and collaboration, assuring overall quality of study data</li> <li class="font-claude-response-body whitespace-normal break-words pl-2" data-sourcepos="13:1-13:222;927-1148">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</li> <li class="font-claude-response-body whitespace-normal break-words pl-2" data-sourcepos="14:1-14:152;1149-1300">Data Reconciliation (e.g., Vendor, SAE) including coordination of transfers and issue resolution with other functional areas and/or 3rd party vendors</li> <li class="font-claude-response-body whitespace-normal break-words pl-2" data-sourcepos="15:1-15:127;1301-1427">Investigation and remediation of reviewer-reported data issues such as from statistical, safety, clinical or medical reviews</li> <li class="font-claude-response-body whitespace-normal break-words pl-2" data-sourcepos="16:1-16:191;1428-1618">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</li> <li class="font-claude-response-body whitespace-normal break-words pl-2" data-sourcepos="17:1-17:246;1619-1864">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</li> <li class="font-claude-response-body whitespace-normal break-words pl-2" data-sourcepos="18:1-18:80;1865-1944">Responsible for submitting queries in the EDC and with the central laboratory</li> <li class="font-claude-response-body whitespace-normal break-words pl-2" data-sourcepos="19:1-21:72;1945-2266">Develops, Maintains, Reviews, Approves and Archives DM Project Documentation including: <ul class="[li_&]:mb-0 [li_&]:mt-1 [li_&]:gap-1 [&:not(:last-child)_ul]:pb-1 [&:not(:last-child)_ol]:pb-1 list-disc flex flex-col gap-1 pl-8 mb-3" data-sourcepos="20:3-21:72;2037-2266"> <li class="font-claude-response-body whitespace-normal break-words pl-2" data-sourcepos="20:3-20:160;2037-2194">Case report forms, edit check specifications, Data Management Plan, Data Review Plan, CRF Completion Guidelines, and other study-specific plans as required</li> <li class="font-claude-response-body whitespace-normal break-words pl-2" data-sourcepos="21:3-21:72;2197-2266">Data review listing specifications and data transfer specifications</li> </ul> </li> <li class="font-claude-response-body whitespace-normal break-words pl-2" data-sourcepos="22:1-22:196;2267-2462">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.</li> <li class="font-claude-response-body whitespace-normal break-words pl-2" data-sourcepos="23:1-23:57;2463-2519">Manage and store data transfers from 3rd party vendors</li> <li class="font-claude-response-body whitespace-normal break-words pl-2" data-sourcepos="24:1-24:87;2520-2606">Development and management of patient profiles for clinical review and data cleaning</li> </ul> <h2 class="text-text-100 mt-3 -mb-1 text-[1.125rem] font-bold" data-sourcepos="30:1-30:24;2720-2743">Minimum Requirements</h2> <p class="font-claude-response-body break-words whitespace-normal" data-sourcepos="32:1-32:45;2745-2789"><strong>Must have</strong> undergraduate degree and 4-6 years of industry experience</p> <p class="font-claude-response-body break-words whitespace-normal" data-sourcepos="38:1-38:22;2869-2890"><strong>Skills/Abilities:</strong></p> <ul class="[li_&]:mb-0 [li_&]:mt-1 [li_&]:gap-1 [&:not(:last-child)_ul]:pb-1 [&:not(:last-child)_ol]:pb-1 list-disc flex flex-col gap-1 pl-8 mb-3" data-sourcepos="39:1-51:79;2891-3846"> <li class="font-claude-response-body whitespace-normal break-words pl-2" data-sourcepos="39:1-39:42;2891-2932">Proven ability to meet strict deadlines</li> <li class="font-claude-response-body whitespace-normal break-words pl-2" data-sourcepos="40:1-40:91;2933-3023">Manage competing priorities and ability to be flexible and receptive to changing demands</li> <li class="font-claude-response-body whitespace-normal break-words pl-2" data-sourcepos="41:1-41:61;3024-3084">Excellent organizational skills and time management skills</li> <li class="font-claude-response-body whitespace-normal break-words pl-2" data-sourcepos="42:1-42:104;3085-3188">Good working knowledge of Microsoft Office and web-based applications (e.g., Word, Excel, Powerpoint)</li> <li class="font-claude-response-body whitespace-normal break-words pl-2" data-sourcepos="43:1-43:93;3189-3281">Proven ability to follow instructions/guidelines, work independently and on own initiative</li> <li class="font-claude-response-body whitespace-normal break-words pl-2" data-sourcepos="44:1-44:93;3282-3374">Excellent attention to detail and accuracy maintaining consistently high-quality standards</li> <li class="font-claude-response-body whitespace-normal break-words pl-2" data-sourcepos="45:1-45:67;3375-3441">Excellent written/verbal communication and report writing skills</li> <li class="font-claude-response-body whitespace-normal break-words pl-2" data-sourcepos="46:1-46:67;3442-3508">Sound judgment, independent thinking, and decision-making skills</li> <li class="font-claude-response-body whitespace-normal break-words pl-2" data-sourcepos="47:1-47:30;3509-3538">Self-motivated and flexible</li> <li class="font-claude-response-body whitespace-normal break-words pl-2" data-sourcepos="48:1-48:105;3539-3643">Ability to establish and maintain effective working relationships with coworkers, managers and clients</li> <li class="font-claude-response-body whitespace-normal break-words pl-2" data-sourcepos="49:1-49:74;3644-3717">Good understanding of operational metrics, productivity and initiatives</li> <li class="font-claude-response-body whitespace-normal break-words pl-2" data-sourcepos="50:1-50:50;3718-3767">Demonstrate effective project management skills</li> <li class="font-claude-response-body whitespace-normal break-words pl-2" data-sourcepos="51:1-51:79;3768-3846">Knowledge of global standards related to clinical data management activities</li> </ul> <p></p><div class="content-conclusion"><p>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.</p> <p>Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.</p></div>