Your Purpose

Alpha-9 Oncology is seeking a highly motivated Clinical Trial Manager/Senior Manager, Clinical Operations with a passion for team work and a strong background in vendor management to provide operational expertise and leadership to one or more radiopharmaceutical clinical studies You will partner with the Clinical Operations Study Lead, Clinical Development, Program Management and CMC Operations to ensure timely and efficient delivery of all operational aspects of our clinical trial in accordance with the appropriate clinical trial standards including ICH/GCP and applicable regulations. This role may involve direct supervision and mentoring of team members as the Clinical Operations team grows. This role is based in our San Francisco office.

How You’ll Contribute

• Contribute to the development of clinical trial timelines, budget and risk/mitigation strategies.
• 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 vendor contracts and budgets, tracks vendor payments against contracted scope of work, and escalates variances to the Clinical Operations Study Lead
• Responsible for day-to-day management and developing effective working relationships with all study vendors.
• Provide operational input into the development of clinical protocols, informed consent, study manuals, study reports, eCRF and other key operational/regulatory documents.
• Establish close cross-functional relationships with Data Management and Clinical Development to oversee eCRF completion and data quality issues; and CMC Operations to forecast drug product needs.
• 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.
• Oversee the forecasting and management of non-clinical supplies (e.g. lab kits) to ensure sites have supplies to run the clinical trial.
• Support tracking of clinical trial metrics, including site activation, patient enrollment, site monitoring issues and risks to the Clinical Operations Lead and other relevant stakeholders.
• 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.
• Build collaborative relationships with key internal stakeholders to facilitate the planning and execution of clinical studies, operational strategy, risk management and mitigation strategies.
• Provide input to the drafting of governance documents, SOPs, work instructions, and other resources.

The Skills You Bring

• Bachelors in Life Sciences with an advanced degree preferred.
• Minimum of 5 years in pharmaceutical/and or biotechnology industry with at least 4 years of experience in clinical operations.
• 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.

What’s in it for you

At Alpha-9 Oncology, we offer a competitive and comprehensive benefits package designed to support all employees. Our benefits include a competitive salary, bonus, equity, 20 vacation days, 5 sick days, a technology allowance, and commuter reimbursement. We also provide generous retirement savings plans with employer matching, extended health benefits, and paid holidays, tailored to local standards in each region. While specific offerings may vary by location, our commitment to fostering a supportive and rewarding work environment is consistent across the company.