1. Serves as the primary study lead ensuring timely and quality deliverables a. Leads the effective and timely development and implementation of clinical systems for assigned studies b.
Uses advanced database programming techniques to solve study specific complex validation or custom development needs c. Understand and manages study metadata to compliment data provisioning in compliance with global standards.
d. Coordinates database development and conducts database testing e. Develops data models to support data review and acquisition standards.
2. Establishes and maintains strong working relationships with study teams, and functional lines. 3. Acts as a technical consultant ensuring appropriate development, maintenance, and use of all system capabilities such as electronic data capture, database programming, edit check programming, report programming, electronic data load, interactive response technology, electronic patient reported outcomes, metadata management and other clinical database development activities.
4. Ensures that systems meet regulatory requirements, internal standards and are deployed with exceptional quality eliminating post production changes.
5. Lead independently or participate in improvement initiatives and / or non-clinical projects. 6. Communicate and ensure that study objectives and priorities are met according to agreed timelines, strategies, quality and scientific standards.
7. Responsible for multiple studies in parallel with minimal supervision / mentoring. 8. Coordinates resources to ensure study objectives are met.
9. Contributes to the development / updates of Clinical Systems processes and supports training on systems and processes to ensure compliance
Bachelor’s degree preferably in computer science, management information systems, or other related area. Fluent English (oral and written).
1. At least 5 years of experience in setup of clinical databases / Data Warehouse using RAVE or OC-RDC or LSH. 2. Excellent interpersonal and written and oral communication skills, with the ability to effectively communicate cross-
functionally 3. Advanced technical skills : a. Expert knowledge of EDC - Medidata RAVE preferred b. Excellent understanding of relational databases c.
Microsoft Office Suite d. Knowledge of other programming languages such as SQL, PL / SQL, VBscript, SAS, C# or Java preferred e.
Experience in Custom Functions is an added advantage. 4. Demonstrated ability to consistently produce detailed, high quality deliverables in a team environment 5.
Excellent problem-solving, project management negotiation and conflict resolution skills