Senior Clinical Trial Assistant

Job Description

Job Description

JOB TITLE : (Sr.) Clinical Trial Assistant, Clinical Operations

LOCATION : Seaport, Boston, MA (Hybrid) DATE PREPARED : August 14, 2025

JOB SUMMARY :

Aveo Oncology is looking for an experienced Clinical Operations professional. The Clinical Trial Assistant will report to the Vice President or Associate Director, Clinical Operations. The role is primarily responsible for supporting close interactive oversight to ensure exceptional execution of AVEO Oncology clinical studies. The Clinical Trial Associate will also be accountable for participating in departmental efficiency initiatives in support of department excellence.

The Clinical Trial Assistant will support monitoring clinical studies across geographic regions, in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), regulatory authority guidance and directives such as Food and Drug Administration (FDA), and International Conference on Harmonization (ICH) guidelines.

The Clinical Trial Assistant will support ensuring quality data for all clinical trials. The Clinical Trial Assistant will support the interactions with CROs and other 3rd party vendors to ensure study milestones and deliverables are achieved according to agreed quality standards and timelines so that data is suitable for regulatory submissions and publications. The Clinical Trial Assistant will also support metrics-based assessments to measure departmental and 3rd party performance on a quarterly basis to meet corporate goals. The Clinical Trial Assistant will also assist with troubleshooting routine site inquiries.

Outside interfaces may include other Aveo Oncology business groups and subsidiaries in the US and abroad, governmental, academic, community and industry organizations.

The Clinical Trial Assistant will not have assigned direct reports.

Good written and verbal communication skills and attention to detail are required and are equally important. The ideal candidate for this role is an individual who is excited to take on new challenges in a dynamic environment. To be successful, the candidate is committed to collaboration and a data driven approach to align with the team’s brand and culture.

PRINCIPAL DUTIES :

Study Management and Leadership

• Collaborate closely with Clinical Team in support of study execution
• Support planning and logistics for internal and external meetings and preparation of agendas, meetings, and meeting minutes
• Support oversight of site compliance with study protocol
• Support and maintain metrics-based tools to assess departmental and 3rd party performance on a quarterly basis to meet corporate goals
• Support adherence to internal procedures for study planning, study conduct, close out and reporting
• Support all inspection readiness and quality initiatives for assigned studies
• Maintains and reviews various study-related tracking systems to determine and report status of clinical trial documents (i.e., distribution, status, retrieval of such documents as protocol, IB, etc.)
• Support Clinical Project Manager and Clinical Research Associate for meeting minutes as requested
• Support study team in tasks such as presentations, mailings to sites, assembly and distribution of Investigator Site Files, newsletters and handling of study documents, copying and filing, correspondence. The CTA will maintain site contact lists, trackers, etc.
• Support the Clinical Project Manager for review of invoices.
• Generate mass mailings upon request of the Clinical Project Manager.
• Perform administrative tasks to support team members with clinical trial execution as needed.

CRO, 3rd Party Vendor Management and Oversight for assigned studies

Knowledge Management / People Management

REQUIRED QUALIFICATIONS / EXPERIENCE (BASIC QUALIFICATIONS) :

About AVEO

AVEO is a commercial-stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer. AVEO currently markets FOTIVDA® (tivozanib) in the U.S. for the treatment of adult patients with relapsed or refractory renal cell carcinoma (RCC) following two or more prior systemic therapies. AVEO continues to develop FOTIVDA in immuno-oncology combinations in RCC and other indications, and has several other investigational programs in clinical development. AVEO is committed to creating an environment of diversity, equity and inclusion to diversify representation within the Company.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.