Clinical Trial Manager

Alpha-9 Oncology•Boston, MA

About The Position

Alpha-9 Oncology is seeking a highly motivated Clinical Operations Manager with a strong background in oncology clinical trials and vendor management to support the day-to-day execution of radiopharmaceutical studies. In this role, you will ensure clinical activities are conducted in alignment with protocols, applicable regulations, and company SOPs while partnering closely with the Clinical Operations Leader, who provides overall study strategy and accountability for trial delivery. This is a hands-on role for someone who enjoys solving problems, coordinating across teams and vendors, and driving progress in a fast-paced clinical environment. You will play a key role in translating study strategy into effective execution and helping advance therapies that impact patients. This role reports to the Clinical Operations Leader.

Requirements

Bachelor’s degree in Life Sciences or a related field; advanced degree preferred, with 3–5 years of experience in clinical operations within the pharmaceutical or biotechnology industry.
Working knowledge of ICH/GCP regulations.
Experience with early-stage oncology trials required; radiopharmaceutical experience preferred.
Strong organization skills and keen attention to detail.
Excellent writing and communication skills.
Proven ability to proactively identify and resolve issues and ability to work independently on operational assignments.
Willingness to roll up your sleeves and get the job done.
Strong interpersonal skills with the ability to interact effectively with all levels of associates both within and outside the organization.

Nice To Haves

advanced degree preferred
radiopharmaceutical experience preferred

Responsibilities

Support tracking of clinical trial timelines, budgets, key operational metrics, and study risks, including site activation, enrollment progress, and monitoring issues.
Support the CRO/vendor selection strategy and development of operational strategies including country & site selection.
Contribute to the development of site feasibility questionnaires and analysis of the feasibility results.
Manage day-to-day relationships with clinical trial vendors, including tracking vendor contracts, budgets, invoices, and payments against contracted scope of work, and escalating issues or variances to Clinical Operations leadership.
Provide operational input into the development of clinical protocols, informed consent, study manuals, study reports, eCRF and other key operational/regulatory documents.
Collaborate with cross-functional teams including Data Management, Clinical Sciences, and Clinical Development to support study execution and resolution of operational issues.
Review study site monitoring reports in alignment with the CRO oversight plan.
Responsible for maintaining internal study documents in the Trial Master File (TMF) and periodically reviewing the CRO TMF for completeness and accuracy.
Support forecasting and management of clinical trial supplies (e.g., lab kits) to ensure sites have the materials needed to conduct studies.
Assist in the preparation of Investigator and Study Coordinator Meetings.
Ensure study adherence to regulatory requirements (ICH, FDA, EMA, etc.) and ICH/GCP guidelines and SOPs.
Provide input to the drafting of governance documents, SOPs, work instructions, and other resources.