EDC / Medidata RAVE System Designer/Programmer (100% Remote)

• This is a system design role
• EDC Programmer/EDC Lead kind of profiles are required
• Must have exp. with Medidata RAVE
• Prior exp. with Veeva Vault would be nice to have
• Must have exp. with EDC (Electronic Data Capture)
• Able to coordinating with other team members such as Statistician, programmer,
• Must have exp. with CDASH and SDTM control terminology
• Protocol trading skill set is required
• TA: SkinCare, EyeCare, Specilaity Phase I, Immunology, Neurology and Oncology
• Must have prior leadership level exp. so that they will able to work with the study team
• Must have good understanding of Google Cloud Platform and ICH guidelines
• Must have good understanding of business
• Must have good communication skills
• Able to work independently
• Real time hands-on exp. is required
• PhD/MS with right years of hands-on exp. would be considerable
• Prior any TA is fine
• Must have 7+ years of exp. (More exp. would be more better)
• There is no such overqualification factor involved in this role
• Protocol reading skill set is required
• Medidata RAVE certification would be a plus but not at all required
• Minimum educational qualification: BS Degree

Responsibilities:

• Actively participates in the development of common data standards and ensures systems designs comply with the standards, as well as with associated protocol requirements. Ensures that the design team utilizes standards
• Establishes and maintains methodology used by the team to design and develop clinical trial systems, benchmarking against industry standards. Ensures that systems are specified to optimize functionality, end user experience, and data flow. Ensures that the design team meets these expectations
• Ensures that TA- and program-level consistency is achieved by the design team
• Accountable for the on-time design and delivery of new clinical systems, integration between systems, as well as any required changes to clinical systems (e.g., EDC, IRT, ePRO). Utilizes project management tools to track study progress and plan work. Anticipates and identifies issues that could affect timelines or quality and develops options and solutions
• Interacts with and influences CDO and cross-functional team members to achieve program and study objectives. Ensures that assigned work product is synchronized with upstream and downstream dependencies
• Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (Google Cloud Platforms), ICH Guidelines, Client Standard Operating Procedures (SOPs), and functional quality standards. Stays abreast of new and/or evolving local regulations, guidelines and policies related to clinical development
• Responsible for coaching and mentoring members of the team, as well as contributing to their skill development
• Leads CDO and cross-functional innovation and process improvement initiatives

Qualifications

• Bachelor s degree in business, management information systems, computer science, life sciences or equivalent. Masters preferred.
• Must have 7+ years of hands-on technical Study build in EDC. Experience with technical study build in Medidata RAVE is required. Veeva EDC technical study build experience is a plus.
• In-depth knowledge of clinical trial processes.
• In-depth knowledge of CDASH (Required) and SDTM.
• Demonstrated performance as a key contributor to initiatives and advancement of the organization.
• Demonstrated ability to influence others without direct authority. Demonstrated ability to successfully coach / mentor in a matrixed environment. Demonstrated effective communication skills and analytical skills.