Clinical Trial Associate
Watertown, MA
Development – Clinical /
Full-time /
On-site
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
Join our growing clinical team! The Clinical Trial Associate supports the planning, execution, and oversight of clinical trials from study start-up through close-out. On a day-to-day basis, you will play a critical role in maintaining study documentation, tracking operational activities, and ensuring compliance with ICH-GCP, regulatory requirements, and internal SOPs. You will collaborate cross-functionally with internal teams, CROs, and clinical sites to ensure high-quality trial conduct.
At Triveni, we enjoy teaching new skills, fostering a culture of continued learning and growth. As
We are a lean team, where opportunity for exposure across multiple programs at various stages of development exists in this role.
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 collection, ethics/IRB submissions, and site activation tracking
· Maintain and QC Trial Master File (TMF), ensuring documents are filed accurately and on time (in paper and/or eTMF systems)
· 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
· Assist with drug supply tracking, site payments, and trial supply logistics as needed
· Support oversight of monitoring visit reports and follow-up
· Assist in creation and revisions of SOPs
· Other projects as assigned
EXPERIENCE & QUALIFICATIONS
· Bachelor's degree in life sciences or a related field
· 3 years of experience in clinical research, with at least 1 years as a CTA in sponsor or CRO setting
· Strong knowledge of ICH-GCP and clinical trial phases (I–3)
· Experience working with eTMF systems (e.g., Veeva, Kivo, etc.)
· Familiarity with CTMS and other clinical trial management tools
· Strong organizational skills with high attention to detail
· 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 contribute to an “office-first” culture is required.
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. Please disregard any other communication that does not originate from this domain name. If you receive any suspicious requests or communications, please verify their authenticity before responding.
