What are the responsibilities and job description for the Senior Clinical Operations Manager position at EPM Scientific?
Join a Leading Innovator in Cell Therapy!
A cutting-edge clinical-stage company specializing in cell therapy is looking to expand its clinical operations team. Focused on transformative treatments for autoimmune diseases and hematological cancers, our unique approach involves harnessing engineered Natural Killer (NK) cells to target B cells for an accessible and scalable therapeutic option.
We have been pioneers in cell therapies and are proud to have one of the first IND filings for Lupus therapies. Currently advancing six indications, with four in clinical stages, we aim to enhance manufacturing and distribution to ensure wider access to our novel treatments. With an experienced leadership team boasting over 20 years in biotech and pharmaceutical sectors, this is an exciting chance to contribute to the field of cell therapy and auto-immunology.
Your Role :
- Lead the planning and execution of global clinical trials alongside the Clinical Project Manager.
- Review and oversee work conducted by the clinical development team.
- Revise essential study-related documents including informed consent forms, laboratory manuals, pharmacy manuals, and case report forms (CRFs).
- Assist with site recruitment, initiation, payments, and close-out activities.
- Facilitate training for new clinical site staff and provide ongoing training for protocol amendments.
- Coordinate timely collection of regulatory documents with in-house teams.
- Guide clinical sites daily, ensuring protocols and safety standards are followed.
- Train staff within the clinical development group.
- Collaborate with the Clinical Project Manager to prepare and update progress reports.
- Track and summarize patient data on treatment responses and survival for active studies.
- Undertake other assigned tasks as necessary.
Qualifications :
Skills & Competencies :
