Clinical Trial Manager/Senior Clinical Trial Manager

Alpha-9 Oncology; San Francisco (CA); On-site; USD 100,000 - 140,000; Full time

Job summary

Alpha-9 Oncology seeks a Clinical Trial Manager/Senior Manager to lead and provide operational expertise for radiopharmaceutical clinical studies. The role involves vendor management, ensuring timely delivery of trial operations, and collaboration across departments. Ideal candidates possess extensive experience in clinical operations and a solid educational background in life sciences.

Benefits

20 vacation days

5 sick days

Technology allowance

Commuter reimbursement

Generous retirement savings plans with employer matching

Extended health benefits

Paid holidays

Qualifications

• Minimum of 5 years in pharmaceutical/biotechnology industry.
• 4 years of experience in clinical operations required.
• Working knowledge of ICH/GCP regulations.

Responsibilities

• Develop clinical trial timelines, budgets, and risk strategies.
• Manage vendor contracts and day-to-day vendor relationships.
• Ensure adherence to regulatory requirements and ICH/GCP.

Skills

Vendor Management

Communication

Organization

Problem Solving

Education

Bachelor's in Life Sciences

Job description

Clinical Trial Manager/Senior Clinical Trial Manager

Clinical Trial Manager/Senior Clinical Trial Manager

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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.

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.

Company Summary

Alpha-9 Oncology is a clinical-stage biotechnology company pioneering radiopharmaceutical innovation for solid tumors. Our proprietary scaffolds, composed of optimized binders, linkers, chelators, and radioisotopes, enable targeted radiation delivery to cancer cells, minimizing harm to surrounding healthy tissue. Focusing on innovative targeting moieties, we develop molecules tailored for precise tumor targeting.

Our comprehensive platform integrates imaging and therapeutic studies to ensure effective radiation delivery and improved patient outcomes. With a robust pipeline entering clinical trials and strong support from leading healthcare investors, Alpha-9 is positioned for rapid growth and advancement in cancer therapy.

More About Alpha-9 Oncology

Alpha-9 Oncology is committed to fostering a diverse and inclusive workplace and is proud to be an Equal Opportunity Employer. We provide employment opportunities to all qualified applicants without regard to race, ethnicity, religion, age, sex, gender identity or expression, sexual orientation, disability, marital status, family status, national origin, or any other characteristic protected by applicable federal, provincial, or local laws where we operate.

We are dedicated to providing reasonable accommodations to qualified applicants and employees to ensure that everyone can perform their essential job functions in an inclusive environment. For inquiries regarding accommodations in the hiring process or for current employees, please contact a member from our Talent Acquisition team.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

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