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.

KNOWLEDGE MANAGEMENT/PEOPLE MANAGEMENT

• In support of goals, the Clinical Trial Assistant will:
• Assist in updating SOPs
• Support GCP and operational systems training

REQUIRED QUALIFICATIONS/EXPERIENCE (BASIC QUALIFICATIONS):

• Bachelor’s Degree in a Life Sciences
• Minimum of 3 years experience in clinical operations methods and processes in industry setting required
• At least 2 years oncology monitoring experience preferred
• Strong understanding of ICH, GCP, and relevant regulatory requirements
• Good communication skills and proficiency with Microsoft Outlook, Excel, Word and PowerPoint
• Familiarity with setting up and maintaining trial master files and performing file audits preferred
• Proactive and able to work independently
• Ability to prioritize and multi-task with attention to detail
• Strong organizational skills