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Role Overview:
- Lead clinical data management across assigned studies, ensuring high-quality data and compliance with ICH-GCP and company SOPs.
- Serve as primary DM contact for CROs and internal teams, managing timelines, quality, and budget.
Key Responsibilities:
- Oversee database development, data cleaning, and database lock, including external data reconciliation and review.
- Manage CRO and vendor performance, SOWs, and inspection readiness while contributing to process improvements.
Qualifications:
- Bachelor's in Life Sciences or related field with 10+ years of clinical research experience, including 5+ years in clinical data management.
- Experience with EDC systems (e.g., Medidata Rave, Veeva CDMS) and knowledge of CDISC standards.
Oruka Therapeutics
We are developing novel biologics designed to set a new standard for the treatment of chronic skin diseases like plaque psoriasis. As a Nasdaq-listed startup, we foster a vibrant, inclusive culture where everyone is encouraged to bring their authentic selves to work.