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.

  The posted range reflects the current reasonable and good faith estimate of the base salary for this full-time position. Actual compensation will be based on a variety of factors including, but not limited to, relevant skills and experience, educational background and certifications, performance and qualifications, market demand for the role, geographic location and other organizational needs. This role also offers a competitive target bonus, equity, and a comprehensive benefits package.   We are committed to fair pay practices, and we regularly review our compensation programs to ensure they are competitive, equitable, and aligned with our values. Please note that the advertised pay range is not a guarantee or promise of a specific wage.   Triveni Bio, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Official Triveni Bio applications will always be submitted through Lever, our ATS. Any applications that take you to other platforms could be fraudulent. We do not use text or chat applications to conduct interviews or make job offers. Official Triveni Bio correspondence will always be conducted from email addresses ending in @triveni.bio or @hire.lever.co. Please disregard any other communications that do not originate from these domain names. If you receive any suspicious requests or communications, please verify their authenticity before responding.