Senior Clinical Trial Manager

Kyverna Therapeutics

Senior Clinical Trial Manager leading operational delivery of cell therapy clinical trials at Kyverna Therapeutics. Overseeing timelines, budget, quality, and cross-functional coordination for assigned studies.

Posted 7/28/2026full-timeRemote • California • 🇺🇸 United StatesSenior💰 $155,000 - $180,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing cell therapy clinical trials, ensuring compliance with FDA and EMA regulations, and leading cross-functional teams to achieve operational excellence. Proficient in budget management, study documentation, and vendor collaboration to drive successful trial outcomes.

Highest-signal resume keywords

Cell Therapy Study ManagementClinical Trial OperationsRegulatory Compliance (FDA, EMA, ICH-GCP)Budget ManagementVendor Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Study ConductStudy Timeline DevelopmentOperational Metrics ManagementProtocol DevelopmentData Review Plan Development

Soft Skills

LeadershipEffective Decision MakingProblem-SolvingCommunication

Tools & Technologies

Trial Master File (TMF)Informed Consent Forms (ICF)Study Templates

Industry Keywords

BiotechPharmaceuticalClinical OperationsGCP GuidelinesChain of Identity/Custody

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Lead and manage the day-to-day operational execution of assigned cell therapy trials: study startup, site activation, enrollment, monitoring, close-out.
Develop and manage study timelines, budgets, forecasts, and related operational metrics.
Partner with external vendors / CROs / service providers (monitoring, labs, imaging, manufacturing/supply chain for cell product) to ensure high quality and timely deliverables.
Serve as the primary cross-functional operational contact for study teams (clinical operations, data management, biostatistics, regulatory, safety/pharmacovigilance, manufacturing, supply chain, medical affairs, quality).
Ensure compliance with regulatory and quality standards (FDA, EMA, ICH-GCP, relevant local regulations) and internal SOPs.
Participate in protocol development and amendments, informed consent form (ICF) review, CRF/data tool development, TMF (Trial Master File) setup & maintenance, monitoring plan, data review plan, drug/cell-product accountability and reconciliation.
Oversee site feasibility, selection, contracting, start-up (site initiation visits, training, enrollment & retention strategies) and close-out activities.
Monitor study progress, identify risks/issues (enrollment delays, monitor/vendor performance, budget overruns, data quality issues) and implement mitigation strategies.
Foster effective communication across study teams, escalate issues to senior leadership as needed.
Ensure preparation for audits/inspections, maintain high standards of documentation readiness.
Contribute to lessons-learned and process improvement initiatives, particularly around cell-therapy-specific operational challenges (e.g., chain of identity/chain of custody, logistics of product, unique site training).
Review invoices and track study budget according to the forecast, working closely with finance and clinical business operations.
Develop study documents and tools including study, informed consent forms, project plans, budgets, study templates, and other materials as needed.
Vendor Management – Contribute to or lead cross-program vendor management activities.
Contribute to SOP development within the Clinical Operations team

Requirements

What you’ll need

B.S. degree with minimum 5+ years of experience in clinical operations including managing clinical trials in biotech, pharmaceutical.
Strong clinical study conduct experience from start-up through close-out.
Strong leadership, effective decision making, and problem-solving skills required.
Established Cell Therapy /CAR T study experience required.
Working knowledge of relevant GCPs and FDA/EMA regulations.
Knowledgeable of current ICH GCP guidelines and applicable regulations.
Ability to work effectively with minimal supervision and multi-task activities to effectively manage deliverables across all trials.
Experience in small/mid biotechnology environment (startup mindset).
Excellent written and verbal communication skills.

Benefits

Comp & perks

Bonus
Benefits
Participation in the company’s stock plan