Senior Clinical Trial Associate & CTA — Global Trials + Equity

Triveni Bio, Inc.; Watertown (MA); Presencial; USD 70.000 - 90.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Bonus

Equity

Benefits package

Descripción de la vacante

Triveni Bio, Inc. is seeking a CTA/Sr. Clinical Trial Associate to plan, execute, and oversee clinical trials from start-up to close-out.

You will maintain study documentation, track operational activities, and ensure ICH-GCP regulatory compliance in collaboration with internal teams, CROs, and sites. The role requires a life sciences degree and at least 2 years of CTA experience, with strong organizational and communication skills.

Formación

• 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-III); global experience 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.

Responsabilidades

• 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.

Conocimientos

CTA experience

ICH-GCP knowledge

CTMS familiarity

eTMF systems

CRO/vendor collaboration

Site activation tracking

Documentation coordination

Strong communication

Educación

Bachelor's degree in life sciences

Herramientas

Veeva

Kivo

Descripción del empleo

Triveni Bio, Inc. is seeking a CTA/Sr. Clinical Trial Associate to plan, execute, and oversee clinical trials from start-up to close-out.

You will maintain study documentation, track operational activities, and ensure ICH-GCP regulatory compliance in collaboration with internal teams, CROs, and sites. The role requires a life sciences degree and at least 2 years of CTA experience, with strong organizational and communication skills.