Sr. Clinical Trial Associate

Triveni Bio•Watertown, MA

2d•$90,000 - $100,000•Onsite

About The Position

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 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 Sr. CTA collaborates cross-functionally with internal teams, CROs, and clinical sites to ensure high-quality trial conduct.

Requirements

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.

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