The Validation Analyst is responsible for understanding software validation in a government regulated environment with special attention to the Software Development Lifecycle (SDLC) validation processes which meet regulatory requirements.
The Validation Analyst ensures that all study work is conducted to CRF-Bracket’s procedures and processes and supports the CRF-Bracket Validation Methodologies. The goal of the Validation Analyst is to foster and promote quality throughout the SDLC/PLC.
The position requires a high level of integrity as this person is working on a client’s project and preparing documents that may be submitted to regulatory agencies (FDA, EMEA etc.) as needed, and actions impact the quality and reliability of the client's’ product.
Essential Duties and Responsibilities:
Skills & Competencies
Competencies & Personal Attributes
CRF Bracket was formed in 2018 by the merger of CRF Health and Bracket to provide life science companies with patient-centric technology solutions that advance clinical research and transform the patient experience. Our solutions are trusted by pharmaceutical companies of all sizes, including all of the top 20 pharmas, as well as CROs, biotechs, and academic institutions on over 4,000 global clinical trials. For nearly 20 years, we have been committed to helping life science companies bring life-changing therapies to patients and communities around the world. The culture our founders instilled continues to drive our values today as we are innovative, results-driven, and deeply committed to our customers. We believe each and every person in our company plays a part in our success—our employees are proud, passionate, and own their contributions, both individually and in collaboration with an inspiring team of colleagues.