CTA / Sr. Clinical Trial Associate

COMPANY INTRODUCTION

 

Triveni Bio is breaking new ground in the identification of novel disease targets – working at the convergence of human genetics, best-in-class antibody design, and precision medicine.  We are pioneering a Mendelian genetics-informed precision medicine approach to develop functional antibodies for the treatment of immunological and inflammatory (I&I) disorders. Our lead antibody program (TRIV-509) targets kallikreins 5 and 7 (KLK5/7) to directly impact skin barrier function, inflammation, and itch – providing a meaningful and much needed potential treatment option for patients with atopic dermatitis and other barrier disorders. In all the work we do, we adhere to our core values: patient impact, bold and rigorous science, open collaboration, kindness & respect.

SUMMARY 

The CTA/Sr. Clinical Trial Associate supports the planning, execution, and oversight of clinical trials from study start-up through close-out. This individual plays a critical role in maintaining study documentation, tracking operational activities, and ensuring compliance with ICH-GCP, regulatory requirements, and internal SOPs. The CTA / Sr. CTA collaborates cross-functionally with internal teams, CROs, and clinical sites to ensure high-quality trial conduct.

RESPONSIBILITIES

• Provide coordination, administrative support and tracking of trial activities to meet department and program goals.  Support the set-up, maintenance and close-out of clinical trials
• Assist with study start-up activities including vendor systems builds, regulatory document review, ethics/IRB queries, and site activation tracking
• Maintain and QC Trial Master File (TMF), ensuring documents are filed accurately and on time
• Support preparation and review of study documents (e.g., protocols, ICFs, study plans and Manuals etc.)
• Track study metrics and site performance using CTMS and spreadsheets
• Organize and attend internal and external study meetings; prepare agendas, generate meeting minutes, track action items and ensure team remains accountable to set deadlines
• Work closely with CROs, vendors, and clinical sites to facilitate communication and resolve issues
• Support oversight of monitoring visit reports and follow-up
• Assist in creation and revisions of SOPs

EXPERIENCE & QUALIFICATIONS

• Bachelor's degree in life sciences or a related field
• 2 years of experience as a CTA in sponsor or CRO setting.
• Knowledge of ICH-GCP and general understanding of the drug development process
• Experience working in clinical trial phases (I–3), global experience is a plus.
• Experience working with eTMF systems (e.g., Veeva, Kivo, etc.)
• Familiarity with CTMS and other clinical trial management tools
• Experience working with CROs and other study related vendors
• Strong organizational skills with high attention to detail
• Excellent written and verbal communication skills
• Ability to work independently in a fast-paced, deadline-driven environment
• Comfortable collaborating in a cross-functional, global team
• Ability to work on-site and adhere to an “office-first” culture is required.