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Full-Time

Senior Clinical Trial Manager

Confirmed live in the last 24 hours

Tr1X

Tr1X

11-50 employees

Develops T cell-based therapies for autoimmune diseases

Biotechnology

Compensation Overview

$145k - $165kAnnually

+ Stock Options

Senior, Expert

La Jolla, San Diego, CA, USA

Category
Healthcare Administration & Support
Medical, Clinical & Veterinary
Required Skills
Communications
Management
Requirements
  • Bachelor's or Master's degree
  • 5 or more years of direct study management experience
  • Experience in cell and/or gene therapy trials
  • Strong working knowledge of ICH/GCP regulations
  • Experience in Inflammatory Bowel Disease, GvHD, or other autoimmune indications
  • Experience in pre-NDA, Phase 1 Fist in Human clinical trials
  • Experience with electronic systems such as eTMF, CTMS, EDC, etc
  • Excellent interpersonal, written, verbal communication, computer, organization, and administrative skills
  • Legally entitled to work for any employer in the US
Responsibilities
  • Serve as a Study Lead to ensure clinical study activities are executed per timeline and budget
  • Oversee study management for accurate execution and high quality data
  • Generate clinical trial protocols and amendments
  • Facilitate CRO/Vendor selection process
  • Develop critical study documents
  • Assist with internal meeting agendas and meeting minutes
  • Provide Regulatory Affairs with Site Essential Regulatory Documents
  • Develop and ensure compliance with clinical monitoring plan
  • Partner in the development of the case report form design process
  • Liaise with CMC team for drug supply monitoring
  • Manage safety reporting to sites and regulatory agencies
  • Audit clinical data reports for accuracy and trends
  • Contribute to SOP development and review process
  • Ensure Trial Master File is maintained
  • Provide frequent study updates to senior management
  • Participate in internal clinical program meetings
  • Manage direct reports and assigned activities

Tr1X is an excellent place to work for those interested in cutting-edge biotechnology and making a significant impact in the medical field. This company leverages a unique blend of genetic engineering and T cell biology to develop cellular therapies aimed at curing autoimmune and inflammatory diseases. Their focus on scalable solutions and immune system rebalancing offers a compelling environment for professionals passionate about pioneering healthcare advancements and contributing to innovations that can transform patient lives.

Company Stage

Series A

Total Funding

$75M

Headquarters

San Diego, California

Founded

2018

Growth & Insights
Headcount

6 month growth

10%

1 year growth

93%

2 year growth

1450%