About the job
Oruka Therapeutics (Nasdaq: ORKA) develops biologic therapies aimed at improving outcomes for chronic skin conditions, including plaque psoriasis. The company’s portfolio, built in partnership with Paragon Therapeutics, focuses on antibody treatments that address the underlying causes of dermatological and inflammatory diseases. More information can be found at www.orukatx.com.
This Trial Master File (TMF) Manager position is fully remote. Oruka Therapeutics is headquartered in Waltham, Massachusetts.
Role overview
The TMF Manager serves as the main point of contact for Clinical Study Teams on all aspects of TMF management. This role is responsible for shaping and maintaining quality oversight processes for clinical trial documentation at Oruka Therapeutics.
Main responsibilities
- Act as the primary contact for TMF management within Clinical Study Teams.
- Develop and improve quality oversight processes for TMF management in clinical trials.
- Review and approve TMF documents to ensure accuracy and regulatory compliance.
- Co-author and manage essential TMF documents, such as the TMF Plan, Index, SOPs, and related guidance materials.
- Monitor TMF quality by reporting metrics, performing periodic SOP adherence checks, and resolving outstanding queries or CAPAs.
- Support Clinical Operations Management with projects, process development, and strategic initiatives.
- Lead training sessions for TMF stakeholders to promote consistent understanding and application of TMF processes.
- Oversee external vendors to ensure study documents meet ICH-GCP guidelines, regulatory standards, and both internal and external SOPs.
- Maintain inspection readiness for assigned studies at all times.
