About CG Oncology, Inc.
Are 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.
About the role
The Clinical Trial Manager (CTM) leads the day-to-day operational execution of assigned clinical trials and serves as a key member of the cross-functional study team. The CTM works in close partnership with the Clinical Project Manager (CPM), who serves as the Study Lead, to ensure study activities are completed in accordance with established timelines, quality standards, budget expectations, protocol requirements, applicable regulations, and company procedures. The CTM provides operational oversight of Clinical Research Organizations (CROs), vendors, sites, and study activities from study start-up through closeout; supports identification and mitigation of operational risks; drives issue resolution and follow-up; and escalates significant risks, decisions, and recommendations to the CPM. This role may support studies across phases, indications, geographies, and operating models within the CG Oncology portfolio.
Essential Functions
- Leads day-to-day operational execution of assigned studies; maintains study timelines, milestones, operational metrics, deliverables, dependencies, decisions, and action items; facilitates operational study team and vendor meetings; and provides clear status updates and recommendations to the CPM.
- Provides day-to-day operational oversight of CROs and study vendors to ensure enrollment, data collection, and other study deliverables are completed in accordance with study timelines, quality expectations, approved scope, and study objectives. Reviews vendor performance, deliverables, reports, budgets, and metrics; supports scope-of-work and change-order review; and escalates performance, quality, timeline, or budget concerns to the CPM.
- Oversees monitoring and site-management activities performed by internal staff, CROs, or other service providers by reviewing monitoring metrics, visit-report quality and timeliness, protocol deviations, significant site issues, follow-up actions, and trends. Participates in monitoring visits when appropriate.
- Collaborates with Clinical Operations, Clinical Development, Data Management, Biostatistics, Regulatory, Pharmacovigilance, Quality, Clinical Supply, Finance, and external partners to support timely, accurate, and compliant study execution and clinical data review.
- Serves as the day-to-day Clinical Operations lead for assigned study activities under the strategic direction of the CPM. Coordinates operational workstreams, drives follow-up and issue resolution, and escalates significant risks, decisions, resource needs, and changes in scope to the CPM and Clinical Operations leadership, as appropriate.
- Identifies operational risks and issues that may affect participant safety, data quality, enrollment, timelines, budget, supply, or study deliverables; develops and tracks mitigation plans with the study team; and escalates significant matters to the CPM with recommended options.
- Maintains operational issue, risk, decision, and action tracking as required and ensures study decisions, mitigations, and follow-up are documented in the appropriate systems.
- Coordinates study start-up, site activation and maintenance, amendment implementation, study conduct, and closeout activities applicable to the assigned study and operating model.
- Contributes operational expertise to study-document development. Participates in ongoing review of clinical data, enrollment metrics, protocol deviations, and operational quality indicators; collaborates with appropriate functions to ensure timely follow-up; and supports data cuts, interim analyses, and database-lock readiness.
- Prepares, reviews, and maintains study-related plans, tools, trackers, training materials, meeting documentation, and other operational documents within the CTM area of responsibility.
- Coordinates and reviews site-facing study documents and tools, including site-specific informed consent forms, worksheets, investigator agreements, and site-payment materials, in partnership with the responsible functions.
- Supports management of the study budget and financial tracking by reviewing invoices, purchase orders, forecasts, and actual spend against approved budgets and escalating variances to the CPM.
- Ensures assigned operational activities are conducted in compliance with the protocol, applicable Good Clinical Practice requirements, regulations, company procedures, and study plans. Supports inspection readiness; Trial Master File quality, completeness, timeliness, and reconciliation; protocol deviation review and trend identification; audit and inspection activities; and timely resolution of quality findings and corrective actions.
- Participates in the selection, training, and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function.
Qualifications
- Bachelor’s degree in a life science or a health-related field.
- Five (5) years or more of progressive clinical research experience within the biotechnology, pharmaceutical, or clinical research organization environment, including at least two (2) years in clinical trial management, study management, lead monitoring, or a comparable operational role. Oncology and sponsor-side experience are preferred.
- Experience supporting clinical trials through multiple stages of the study lifecycle, including study start-up, conduct, data review, and closeout. Experience working on multidisciplinary study teams and with outsourced service providers is required; global trial experience is preferred.
- Available for approximately 25% travel both domestic and international, including overnight stays.
- Ability to proactively perform and complete duties with minimal supervision in an accurate and timely manner.
- Ability to travel for site visits and meetings.
- Current professional clinical research certification, such as ACRP or SOCRA certification, is preferred but not required.
- Oncology clinical trial experience is preferred. Experience with oncolytic immunotherapy, intravesical therapy, or other complex treatment modalities is beneficial but not required.
- Experience in a small or growing biotechnology organization and in sponsor oversight of CROs and study vendors is preferred.
Work Authorization: Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.
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 Rewards
CG 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
EQUITYSPECIAL RECOGNITION
Well-Being Benefits
In 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 2 x base salary + Voluntary Plans
ADDITIONAL EXCLUSIVE BENEFITS - Voluntary Legal, Pet, Plus More
CG Oncology is an Equal Opportunity Employer:
All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. At CG Oncology, we are building a community of intelligent and passionate team members that share our Vision, Mission and Values, and while the biotechnology space can feel limited in BIPOC, non-binary and even female representation, we endeavor to make hiring decisions that will continue to grow and support our team in the direction of maintaining cultural diversity and sustainability.
Bachelor's degree in life science or health-related field; 5+ years progressive clinical research experience including 2+ years in clinical trial management; experience with outsourced service providers; ~25% travel; U.S. work authorization without sponsorship.
Key Responsibilities
- leading study execution
- overseeing CROs
- managing study budgets
Job Details
- Category: Project and Program Management
- Seniority: Senior Level
- Commitment: Full Time
- Workplace: Remote — United States
- Salary: USD 155,000 – 170,000 / year
- Languages: English
Benefits
- 401k matching
- Generous paid time off
- Retirement plan
About CG Oncology, Inc.
A patient-centered biotech company focused on developing bladder-saving therapeutics for bladder cancer. — Industry: Healthcare