USAClinical Trial Manager
1 мес. назад
USAMiddle
clinical trial managementvendor managementbudget trackingrisk managementfeasibility analysis
Manage clinical trial operations in oncology focusing on vendor management and study execution.
Требования
- 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.
- 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.
Другое
- 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. How You’ll Contribute
- 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.
- 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.
- 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.