What are the responsibilities and job description for the Senior Clinical Trial Manager position at EPM Scientific?
Senior Clinical Trial Manager
At {company}, we are expanding our clinical operations team to support the development of innovative treatments for autoimmune diseases and hematological cancers.
We utilize a unique approach to cell therapy, harnessing Natural Killer (NK) cells that target B cells. These NK cells are engineered as an 'off-the-shelf' therapy, making treatment more accessible and scalable.
Our team has been a pioneer in cell therapies, with one of the first IND filings for Lupus using cell therapy. We are advancing six indications-four in clinical stages-and working to streamline manufacturing and distribution to improve access to novel treatments.
Key Responsibilities:
- Support the Clinical Project Manager in planning and overseeing company-sponsored global clinical trials.
- Review and lead work completed by members of the clinical development team.
- Lead or assist in revising study-related documents, such as informed consent forms and case report forms.
- Provide assistance with site recruitment, initiation, payments, and close-out activities.
- Contribute to the training of new clinical site staff and offer additional training for protocol amendments.
- Coordinate with in-house teams to ensure timely collection of regulatory documents as required.
- Offer daily guidance to clinical sites, including interpretation of protocols and adherence to protocol safety standards.
Requirements:
- Bachelor's degree with 7-10 years of experience in clinical research.
Competencies:
- Proficiency in MS Office applications.
- Strong written and verbal communication skills, with excellent organizational and multitasking abilities.
- Ability to maintain corporate confidentiality.
