Sr. Clinical Trial Manager
San Diego, California (Hybrid)
Compensation: $160,000-180,000 + Bonus + Equity
Company Summary:
We are partnered with an Cell Therapy focused company looking to revolutionize the way we approach cell therapy within Oncology & Autoimmune diseases. Their proprietary approach will dramatically cut time and cost associated with other cell therapy treatments like CAR-T. Their leadership team is equally exciting as their science with their CEO and CMO successfully raising hundreds of millions in funding at other organizations while gaining successful approvals. Their strong leadership has also led to a successful IPO for this organization earlier this year. If interested in learning more don't hesitate to apply.
Primary Responsibilities:
- Support the Clinical Operations team in executing clinical trials, from protocol development through to the final study report.
- Prepare and manage study-related documentation.
- Organize and facilitate study and departmental meetings, document meeting minutes, and ensure proper archiving of study files.
- Oversee the coordination of clinical trial equipment and supplies.
- Manage cross-functional project activities, such as Clinical Data Review Meetings.
- Ensure team adherence to required study-specific training.
- Conduct Trial Master File (TMF) reviews to ensure completeness.
- Maintain inspection readiness and assist sites in preparing for clinical audits or inspections.
- Assist with managing budgets.
- Support daily clinical trial operations, ensuring adherence to SOPs, ICH/GCP guidelines, and other regulatory standards.
- Tasks may include tracking subject and site activity/metrics and performing quality checks on various aspects of the clinical study.
- Proactively identify and address issues related to functional deliverables.
- Assist with study setup, including protocol/synopsis development, informed consent form review, and regulatory submissions, as well as preparing operational and training manuals, study plans (visit logs, drug inventory, monitoring plans), and other related documents.
- Collaborate with CROs to ensure timely collection and archiving of TMF documents for assigned studies or programs.
- Coordinate with regulatory affairs to submit essential documents to authorities.
- Support study completion activities with CROs and sites, including TMF and drug reconciliation, and ensure all documents are ready for the Clinical Study Report (CSR).
- Communicate effectively with study teams and work closely with Clinical Trial Managers and Asset Leads.
- Contribute to process improvement and quality initiatives related to study execution and deliverables.
- Ensure study timelines are met, including first patient in (FPI), enrollment targets, site activation, and data cleaning goals.
Qualifications:
- 5+ years clinical operations experience.
- Experience in Autoimmune, or another complex therapeutic area
