Manager, Clinical Data Management

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ProKidney Corp.

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2015

🧬 Biotechnology

⚕️ Healthcare Insurance

Biotechnology • Healthcare Insurance

ProKidney Corp. is a late clinical-stage biotechnology company focused on pioneering cell therapy as a treatment for Chronic Kidney Disease (CKD). Their innovative approach aims to transform the therapeutic options available for advanced CKD by preserving kidney function, potentially delaying or eliminating the need for dialysis. With a focus on an area of high unmet medical need, ProKidney's cell therapy candidate, rilparencel, is at the forefront of clinical studies to provide alternative solutions for patients with limited treatment options. The company is committed to advancing its pipeline through clinical and regulatory developments and actively participates in healthcare conferences to bring attention to its groundbreaking work in CKD treatment.

📋 Description

• Own data management study deliverables end-to-end — from data capture tool development through database lock • Partner closely with CROs and third-party vendors to keep clinical data accurate, timely, and audit-ready • Represent DM as the functional lead at study team meetings; responsible for communication and collaboration • Assumes ownership for DM study deliverables within DM scope of services including overseeing overall quality • Data Reconciliation including coordination of transfers and issue resolution with other functional areas • Investigation and remediation of reviewer-reported data issues • Coordinates with ProKidney, CRO and other 3rd party vendors to develop and maintain DM startup timelines • Responsible for submitting queries in the EDC and with the central laboratory • Ensure quality check of clinical data as appropriate for statistical review, interim review, and 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

🎯 Requirements

• Must have undergraduate degree and 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.

🏖️ Benefits

• ProKidney is an equal employment opportunity employer • 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.