Note: The job is a remote job and is open to candidates in USA. CG Oncology is a patient-centered biotechnology company developing novel immunotherapies for bladder cancer. The Clinical Trial Manager leads the day-to-day operational execution of assigned clinical trials, overseeing CROs, vendors, sites, timelines, budgets, risks, quality, and compliance from study start-up through closeout.
Responsibilities
- 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
Skills
- 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
- 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
- Ability to proactively perform and complete duties with minimal supervision in an accurate and timely manner
- 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
- Oncology and sponsor-side experience are preferred
- Global trial experience is preferred
- Current professional clinical research certification, such as ACRP or SOCRA certification, is preferred
- 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
Benefits
- Annual performance/merit reviews
- Annual performance bonuses
- Equity
- Special recognition
- Fully remote work environment
- Unlimited flexible time off
- 14 observed holidays in 2026
- 401(k) with 100% company Safe Harbor match up to 4% of base salary
- Medical, dental, and vision coverage through PPO and HDHP plans with Cigna/Principal
- HSA with annual company contribution, FSA, and FSA-DC
- Company-paid long-term disability coverage plus voluntary plans
- Company-paid life insurance of 2× base salary plus voluntary plans
- Voluntary legal and pet benefits, plus more
- Well-Being Benefits eligibility begins the 1st of the month after hire; the majority of these benefits are for the US-based workforce
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