Clinical Trial Manager
$145k - $165kOssium Health
About Ossium Ossium's mission is to improve the health, vitality, and longevity of human beings through bioengineering. We develop, manufacture, and bank cell therapy products that apply the power of stem cell science to revolutionize treatment for patients with blood, immune, and orthopedic diseases. At Ossium, we empower our employees, maintain the highest standards of operational excellence, and are a force for good. About the Job We are hiring a Clinical Trial Manager to support the successful execution of our clinical trials and operations. In this role, you'll take ownership of the day-to-day tactical management of ongoing studies, ensuring seamless trial implementation and monitoring. You'll play a key role in launching our PRESERVE II clinical trial, the long-term follow-up of PRESERVE I, and our HOPE expanded access program. This position is ideal for someone who thrives in a hands-on, fast-paced environment-someone eager to collaborate across teams and coordinate with internal partners, CROs, and external vendors to deliver excellence in every aspect of our trials. This role reports to the Senior Director, Clinical Operations.
Required Qualifications
Equal Opportunity Employer/Veterans/Disabled
Required Qualifications
- Degree in Life Sciences & industry-sponsored clinical trial experience:
- BS & 3+ years
- MS/MPH & 1+ years
- Experience with or managing CROs; either from within a CRO in a major role, or from a sponsor-side biotech or pharmaceutical company at the Clinical Trial Manager or Clinical Project Manager level
- Strong written and verbal communication skills, with the ability to share complex information clearly and effectively across teams and stakeholders
- Exceptional organizational and time management abilities, with comfort operating in a fast-moving, dynamic startup environment
- Proven capacity to manage multiple priorities simultaneously, maintaining accuracy and attention to detail
- A collaborative, execution-oriented mindset with the ability to build alignment and drive progress across cross-functional teams
- This position is based in our San Francisco office; we maintain a hybrid schedule of Monday - Thursday in the office, with Friday as a remote work day
- Ability to travel as needed (10% - 15%)
- Qualified candidates must be legally authorized to be employed in the United States; Ossium is unable to provide sponsorship for employment visa status (eg, H-1B or TN status) for this position, either now or in the future
- CRA/site coordinator experience
- Trial experiences in full life cycle of clinical trial
- Experience in cell therapy
- Experience in rare disease; hematologic malignancies (specifically bone marrow transplant)
- Serve as the primary liaison with the CRO supporting PRESERVE II study activities, ensuring alignment on timelines and deliverables
- Review and contribute clinical operations input to key study documents including protocols, investigator brochures, regulatory submissions, clinical study reports, and operational plans developed by CRO partners
- Oversee site feasibility and capability assessments in close collaboration with the CRO and cross-functional teams
- Support additional clinical programs and studies as assigned, working closely with the Senior Director, Clinical Operations to meet strategic and operational objectives
- Partner with cross-functional groups, including Transplant Operations, Regulatory Affairs, and other stakeholders to ensure seamless coordination and successful trial execution
- Help lead and monitor trial execution to ensure compliance with ICH/GCP guidelines, applicable regulations, and company policies
- Organize and lead internal clinical project meetings, fostering collaboration and keeping teams aligned on goals and progress
- Driving completion of critical milestones for the start of PRESERVE II clinical trial
- Supporting the active PRESERVE I study long term follow up
- Collaborating internally with other functions for clinical study implementation
- Conducting clinical project team meetings
- Stock options
- 401(k) matching
- Medical, dental and vision coverage
- Generous paid time off + 11 company holidays
- Employer paid life insurance and long-term disability
- Gym membership/recreational sports reimbursements
Equal Opportunity Employer/Veterans/Disabled
Vacancy posted 23 hours ago
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