Clinical Data Management Manager
Oruka Therapeutics
Oracle
Clinical Data Programmer, Elluminate Specialist
iSoftTek Solutions Inc
full-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteJob Level
Mid-LevelSenior
Tech Stack
SQL
About the role
- Provide technical support and administration for core business packages related to Elluminate.
- Develop and implement data mappings to import into Elluminate, ensuring compliance with programming standards.
- Collaborate with clinical trial project teams and management to adhere to quality standards and project timelines.
- Participate in process development initiatives and provide accurate and timely answers to technical questions.
Requirements
- Bachelor’s degree in Computer Science or equivalent qualification.
- Minimum 5+ years of experience in SQL programming, clinical data programming, and clinical data warehouse mapping in a pharmaceutical company or CRO.
- Strong knowledge of CDISC SDTM model and mapping requirements.
- Excellent analytical, problem-solving, and organizational skills with a high level of comfort sourcing, manipulating, and visualizing clinical data.
- PhD or Master’s in Chemical/Biochemical Engineering, Biology, Biochemistry, or equivalent with 0–1 year of industry experience; OR
- Bachelor’s in Chemical/Biochemical Engineering, Biology, Biochemistry, or equivalent with 3 years of industry experience.
- Biotechnology or pharmaceutical industry experience.
- Hands-on experience at laboratory, pilot, or manufacturing scale for biologics products.
- Knowledge in cell culture process development, bioreactor design/control strategies, scale up/down for mammalian-expressed proteins.
- Strong scientific background.
- Ability to work independently and in cross-functional teams.
- Strong technical writing and presentation skills.
- Experience with statistical analysis software.
