About the roleThe 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.
Essential FunctionsStudy Leadership & Oversight- 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.
Strategic Leadership- 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.
Database Design & Data Quality- 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.
Vendor Management- 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.
Process Improvement & Standards- 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.
Leadership & Mentoring- 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 promotes consistent application of data management standards across studies.
Qualifications- BS/BA in a relevant scientific discipline.
- 12+ years of progressive Clinical Data Management experience in biotechnology, pharmaceutical, or CRO environments.
- Extensive experience leading Data Management activities across Phase I-III clinical trials.
- Demonstrated experience leading global, multi-study, and submission-enabling programs.
- Proven experience developing departmental standards, SOPs, and governance processes.
- Significant experience managing strategic vendor relationships
Please note that CG Oncology does not accept unsolicited information and/or resumes from search firms or agencies for our job postings. Any resumes or client information submitted to our careers page or any employee of CG Oncology by any search firm or agency without an applicable contract in place will become the property of CG Oncology and no fee(s) will be paid.Total RewardsCG Oncology offers very competitive and comprehensive Total Rewards, helping to support and reward our global team of high-performing employees focused on developing bladder-saving therapeutics for patients afflicted with bladder cancer.
- HIGHLY COMPETITIVE SALARIES
- ANNUAL PERFORMANCE/MERIT REVIEWS
- ANNUAL PERFORMANCE BONUSES
- EQUITY
- SPECIAL RECOGNITION
Well-Being BenefitsIn addition to our Total Rewards, CG Oncology offers a variety of Well-Being Benefits to meet the majority of the needs of our unique and growing workforce. These benefits are designed to support our team to achieve a healthy balance between work and their personal lives to remain refreshed, engaged, and creating an environment where each person can find a deeper meaning and purpose in their work.
Well-Being Benefits eligibility begins the 1st of the month after hire. While a majority of these benefits are for our US-based workforce, we continue to assess comparable levels of benefits for our international team members that are aligned with country-specific regulations and their national programs offered.
- FULLY REMOTE WORK ENVIRONMENT
- REST AND RECHARGE BENEFITS - Unlimited Flexible Time Off
- HOLIDAYS -In 2026 we will observe 14 holidays
- RETIREMENT - 401K with 100% company Safe Harbor match up to 4% of base salary
- HEALTH (MEDICAL, DENTAL, VISION) - PPO & HDHP - Cigna/Principal
- HEALTH SPENDING ACCOUNTS - HSA (with Annual Company Contribution), FSA, FSA-DC
- ILLNESS & DISABILITY PROTECTION - Company Paid LTD Coverage + Voluntary Plans
- LIFE INSURANCE - Company Paid 1 x base salary + Voluntary Plans
- ADDITIONAL EXCLUSIVE BENEFITS - Voluntary Legal, Pet, Plus More
