Kyverna Therapeutics logo
Kyverna Therapeutics

Taming Autoimmunity™

Senior Clinical Trial Manager

Clinical ResearchClinical ResearchFull TimeRemoteSeniorTeam 51-200Since 2019H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

3 days ago

Salary

$155K - $180K / year

Seniority

Senior

Bachelor Degree7 yrs expEnglishGoogle Cloud Platform

Job Description

• 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

Job Requirements

  • B.S. degree with minimum 7 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

  • Bonus
  • Benefits
  • Participation in the company’s stock plan

Related Categories

Related Job Pages

More Clinical Research Jobs

Full TimeRemoteTeam 10,001

The Clinical Research Associate is locally responsible for study delivery at assigned sites, acting as the main contact for monitoring conduct to ensure compliance with guidelines like ICH-GCP and local regulations. Key duties include site preparation, initiation, monitoring, and closure, alongside training site staff and driving site performance.

United States
$112K - $168K / year
IntellaTriage logo

Remote Hospice Triage RN PT 10:30p-5a + rotating Sat & Sun 11:30p-8a CST

IntellaTriage

Transform your after-hours care strategy to reduce nurse burnout and improve patient experience

Clinical Research3 days ago
Part TimeRemoteTeam 51-200H1B No Sponsor

We are seeking a compassionate registered nurse (RN) to join our growing team! In this role, you will provide critical after-hours support, triaging hospice patients and family needs over the phone wit professionalism and empathy. You will help ensure ...

RNtriagehospicetelehealth
United States
$25 / hour
Precision Medicine Group logo

Clinical Research Associate II

Precision Medicine Group

Precision Medicine Group delivers specialty services that help its life science clients navigate healthcare challenges. The company entered its 10th year of suc

Clinical Research3 days ago
Full TimeRemote

The CRA II oversees all aspects of study site management to ensure patient safety and data quality, providing guidance on audit readiness and maintaining trial management systems. Responsibilities include conducting all forms of site visits, managing regulatory documentation, performing data review, and handling investigational product inventory and reconciliation.

United States
$91.5K - $137K / year
Precision for Medicine logo

Clinical Research Associate II

Precision for Medicine

Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

Clinical Research3 days ago
Full TimeRemoteTeam 51-200

The CRA II oversees all aspects of study site management to ensure patient safety and data quality, providing guidance on audit readiness standards and tracking study trial management tools. Responsibilities also include conducting all forms of site visits, preparing timely monitoring reports, and managing investigational product inventory and data review activities.

United States
$91.5K - $137K / year