Principal Data Manager

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Full Time Remote, US

Salary Range: $ To $ Annually

A re you ready to make a difference in the world and become part of our patient-centered team that is focused on Attacking Bladder Cancer for a Better Tomorrow? At CG Oncology, we believe that by having exceptionally talented individuals on our team who share our passion and enjoy working together, we can truly achieve our Vision and Mission to benefit patients around the world.

Every day we are making significant advancements across our multiple pipelines and are growing rapidly to meet the needs of our patients who cannot afford to wait to benefit from our novel immunotherapies. Please review this job posting and our Values and if they resonate with you and are what you expect from your organization and team, then we would like to hear from you.

The Principal Data Manager is a recognized subject matter expert responsible for providing strategic leadership and oversight for Clinical Data Management (CDM) across multiple clinical programs and studies. This role establishes data management standards, drives organizational best practices, influences cross-functional development strategies, and serves as a key partner to Clinical Development leadership. The Principal Data Manager provides expert oversight of complex clinical trials, vendor partnerships, data governance initiatives, regulatory submission readiness, and process optimization efforts.

This individual acts as a mentor and technical leader within the organization, ensuring the delivery of high-quality, compliant, and inspection-ready clinical data that supports corporate development objectives.

• Leads all clinical data management activities for assigned clinical studies from start-up through database lock and study closeout.
• Serves as the primary Data Management representative on cross-functional study teams.
• Develops and executes Data Management Plans (DMPs), Data Review Plans, and study-specific data management strategies.
• Provides strategic input into protocol development to ensure data collection requirements support study objectives and regulatory expectations.
• Identifies and mitigates study-level data risks and escalates issues appropriately.

• Leads data management strategy across multiple programs and therapeutic areas.
• Establishes and maintains departmental standards, governance frameworks, and data quality metrics.
• Provides strategic input into clinical development planning and regulatory submission strategies.
• Serves as the senior Data Management representative for executive and cross-functional governance committees.
• Evaluates and implements emerging technologies and industry best practices.

• Leads CRF/eCRF design and review in collaboration with Clinical Operations, Medical, Biostatistics, Regulatory, and Safety teams.
• Oversees database build activities, edit check specifications, derivation requirements, and data validation rules.
• Leads User Acceptance Testing (UAT) and approves database releases. .
• Establishes and drives data review, cleaning, reconciliation, and quality control activities to ensure inspection-ready datasets.
• Oversees query management and data cleaning efforts to support study milestones and database lock timelines.
• Provides oversight of CROs, EDC vendors, central laboratories, imaging vendors, and other external data providers.
• Reviews vendor deliverables, performance metrics, timelines, and quality indicators.
• Leads development and maintenance of Data Transfer Agreements (DTAs), vendor specifications, and reconciliation processes.
• Ensures vendor compliance with study requirements, SOPs, GCP, and applicable regulations.

• Contributes to the development and continuous improvement of departmental SOPs, work instructions, templates, and standards.
• Champions implementation of CDISC and industry best practices for data collection and management.
• Supports inspection readiness and audit preparation activities.
• Drives process optimization initiatives to improve efficiency, data quality, and study execution.
• Provides guidance, mentorship, and training to Clinical Data Managers and junior team members.
• Serves as a subject matter expert (SME) for Clinical Data Management processes and systems.
• Facilitates knowledge sharing and…