eTMF Developer

Smart IMS delivers IT solutions and services that create a sustainable competitive advantage for its clients across the world. The company was founded by business and technology experts with extensive backgrounds in designing, implementing, and managing large and complex IT projects at Fortune 500 companies. Smart IMS core portfolio includes IoT, Cloud and Digital Services, Enterprise Application Management & Development, Smart Advisory & Assessment Services, 24/7 Technical Support Services and SD WAN Services.

·       Build a web-based Content Management System called eTMF that contains records, documents, images, signatures for regulatory compliance.

Qualification:

• Bachelor's degree in related area; and/or equivalent experience/training.
• At least five (5) years of eTMF System development and configuration experience required, including experience in study start-up, system setup, maintenance and closeout activities.
• Subject matter expertise with the TMF Reference Model, clinical trial activities and related terminology.
• Demonstrated experience with CTMS, EDC, and eTMF technologies.
• Extensive knowledge and application of ALCOA FDA standards, Good Clinical Practice, and Good Documentation Practice, per ICH (E6 (R2).
• Experience in clinical trials related roles (i.e. clinical operations and project management) or managing a clinical trial project. Has an understanding of clinical study phases involved in Drug Development and the corresponding records requirements, in accordance to federal regulations.
• Highly proficient in CTMS and eTMF technologies. Experience and skills in navigating EDCs preferred.
• Demonstrated understanding of the clinical study phases involved in Drug Development and the corresponding records requirements, in accordance to federal regulations.
• Thorough knowledge and ability to apply all relevant Federal, state, and university regulations, policies, and federal guidance documents.
• Thorough knowledge and experience with quantitative and qualitative research design; scientific research concepts and terminology.

All your information will be kept confidential according to EEO guidelines.