- Responsible for leading and/or supporting database build activities for EDC clinical studies and related setup tasks including eCRF and study design, edit check programming, randomization, coding setups, external data import/export setups, listings/report development as needed following the appropriate company SOPs
- Generates and maintains all required documentation including the development of specifications, coding, and validation efforts in support of annotated Case Report Forms (eCRF)s, database creation, coding setup, randomization, edit check procedures, import, export setup and processing including SAS and/or Excel datasets, listings, reporting requirements
- Assists in User Access Management for Data Management/Clinical systems as required
- Develop & maintain reporting, data exports, & analytics
- Maintain & improve clinical data infrastructure and related tools
- Lead & support Clinical trials management system (CTMS)
- Provides relevant training, guidance, and support to peers and other department members as required
Skills and Experience:
- 2 + years in Medidata Rave programming
- Oracle Clinical programming experience
- Experience with TSQL, Databases (Oracle, SQL), at least one programming/Scripting language (C#, VB etc.)
- Experience with analytics & reporting tools (such as PowerBI, Qliksense)
- Ability to lead activities performed by technical developers and/or data managers
- Excellent oral and written communication skills in English
- Familiarity/knowledge of FDA regulations (particularly 21 CFR Part 11), web-based Electronic Data Capture (EDC) and clinical data management systems are desirable
- Only qualified applicants will be considered
Let us introduce ourselves
Insightec is a growing medical technology company transforming patient lives through innovative incisionless surgery. Based on two decades of clinical experience and research and development, the company's Exablate® Neuro platform focuses sound waves, guided by MRI, to provide tremor relief to patients with Essential Tremor and Tremor-dominant Parkinson's Disease. Research for future applications in the neuroscience space is underway in partnership with leading academic and medical institutions.
We are a global team united by a common vision to transform healthcare by making focused ultrasound a standard of care for patients. Our culture is built on Our Values of integrity, team, quality, innovation and patient care. We challenge and empower our people to be great at what they do and leverage our different ideas, skills, interests and cultural backgrounds to succeed.
After a recent investment round, Insightec is valued at more than $1B, bringing it to unicorn status. We are over 350 strong in Haifa and K. Ono in Israel, Miami, Dallas, Shanghai and Tokyo.
Do the most meaningful work of your career by joining us in our mission to make the impossible possible.
Insightec is an equal opportunity employer and is committed to a safe work environment free from discrimination, where employees are treated with dignity and respect. Insightec does not discriminate against any employee or applicant on the basis of race, color, religion, national or ethnic origin, sexual orientation, gender identity or expression, age, disability or other characteristics protected by law. We adhere to these principles in all aspects of employment including hiring.