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 Sr. Manager, Clinical Project Management is responsible for hands on day-to-day management of a diverse and complex program of clinical trials directly and with subordinate staff, including the ability to influence and manage contract CROs conducting company-sponsored clinical trials, while ensuring the operational strategy and implementation are consistent with protocol, regulatory, budgetary, and quality objectives. The Sr. Clinical Project Manager reports directly to the Director, Clinical Operations and helps lead phase I-III studies in North America and globally.

Location: Remote

Essential Functions

• Manages study timelines and metrics; participates in selection and management/oversight of external vendors and develops vendor specifications; reviews vendor reports, budgets, and metrics; prepares and presents project debriefings, as required; plans, executes, and attends/manages study-specific meetings as applicable.
• Partners with the Clinical Research Organization (“CRO”) to ensure that patient enrollment and data collection are completed in accordance with study timelines and objectives; escalates risk to timelines and budget as needed; revises scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met.
• Oversees all study-level data monitoring activities; reviews visit reports; attends monitoring visits as required.
• Responsible for monthly Protocol Deviation (PD) review, including oversight of CRA documentation and collaboration with Medical Monitor for medical review.
• Responsible for coordination and oversight of clinical data and listings review for assigned trials.
• Works in a team environment comprising of clinical operations, regulatory, technical operations, quality, and CROs to assess and meet data management needs; including ensuring data is accurately collected in an efficient and timely manner.
• Uses operational and therapeutic expertise to optimize trial design and execution; works with the study team to design clinical trial protocols and assists in developing/managing an ongoing data review plan to ensure detection of data trends and to ensure study objectives are met; supports the creation of the ICF template, CRFs, etc.
• Prepares and/or reviews study-related documents.
• Prepares/reviews site study documents (i.e., site-specific informed consent, study tools/worksheets, investigator contracts, and site payments).
• Responsible for the management of study budget and maintains it within financial goals, including review of invoices against approved budget.
• Ensures all clinical trials are executed in compliance with ICH/GCP guidelines/regulations and applicable SOPs: participates in the planning of quality assurance activities and coordinates resolution of audit findings; ensures audit-ready condition of clinical trial documentation including central clinical files; reviews monitoring reports to ensure quality and resolution of site-related issues; coordinates and assists in the planning of regulatory or ethics committee activities, as appropriate
• Participates in the selection, training, and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function.
• Mentors, leads and supervisors other Clinical Trials roles to achieve both role and team objectives.

Qualifications

• Seven (7) years or more of progressive clinical management experience with the biotech / pharmaceutical industry or in a clinical research organization.
• Three (3) years of experience in full-cycle drug development required including participation in multi-disciplinary project teams working on phase I-IV global clinical studies.
• Prior experience supporting regulatory filings, inspections, and audits.
• Available for approximately 25% travel both domestic and international, including overnight stays.
• Small biotech experience preferred

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
• EQUITY
• SPECIAL 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 2025 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

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.