Ossium Health

Clinical Trial Manager

San Francisco, California, United States

No sponsorship$145k-$165kDetected 44 days ago

GCPProject ManagementClinical TrialsFDA RegulatoryCommunicationCollaborationTime ManagementRegulatory Affairs

About the role

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 role reports to the Senior Director, Clinical Operations.

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
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
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.
We are hiring a Clinical Trial Manager to support the successful execution of our clinical trials and operations.

Degree in Life Sciences & industry-sponsored clinical trial experience:
MS/MPH & 1+ years
Experience with or managing CROs
Strong written and verbal communication skills, with the ability to share complex information clearly and effectively across teams and stakeholders
Ability to travel as needed (10% - 15%)
Qualified candidates must be legally authorized to be employed in the United States
Ability to travel as needed (10%
Required Qualifications

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
Oversee site feasibility and capability assessments in close collaboration with the CRO and cross-functional teams
Driving completion of critical milestones for the start of PRESERVE II clinical trial

This position has a salary range of $145,000 - $165,000 annually.
The successful candidate's starting salary will be determined based on, but not limited to, job-related skills, experience, qualifications, and market conditions.

Ossium's mission is to improve the health, vitality, and longevity of human beings through bioengineering.
Ossium Health complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities.
Ossium Health takes a market-based approach to pay.
We offer a full slate of employee benefits including:

Employer/Veterans/Disabled
If reasonable accommodation is needed, please contact our People Team at careers@ossiumhealth.com or 650-285-0603.
Equal Opportunity Employer/Veterans/Disabled

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

This listing is sourced directly from Ossium Health's careers page and normalized into a canonical job model.