Principal Clinical Programming Analyst-Remote

Title: Principal Clinical Programming Analyst
Duration: 06 Months-Contract on W2
Location: Irvine, CA -92614
Pay Rate-$71.00/hr
Shift Timings: 8 AM to 5 PM
Schedule Notes: 100% Remote 6 month duration 20-30 Hours per week.
Job Description:
Lead the development of clinical study databases in the Rave EDC system according to the department SOPs, including programming complex Custom Functions in C#. Activities include but not limited to, planning, design, programming, testing, validation, and all related documentation tasks.
Act as a SME on core business software solutions (e.g., RAVE EDC system) to provide novel end-to-end software solutions that improve, automate, and solve complex business process challenges.
Plan and lead the design and implementation of complex functional modules and provide clinical programming expertise regarding clinical trials, protocols, and case report form with cross functional teams.
Lead the development of specifications for complex systems and/or processes, system upgrades/enhancements and integration; and engage IT to deliver higher level support to users.
Oversee the documentation of clinical database structures, specifications, reports and other database-related tasks during the life of a clinical trial to ensure data quality and compliance with regulatory guidelines and company SOPs.

Skills:
Experience with Rave EDC system and complex Custom Functions in C#.
Extensive knowledge of clinical programming as it relates to business processes.
Extensive knowledge of relational databases, systems, and programming languages.
Extensive knowledge and understanding of policies, procedures and guidelines relevant in the development of clinical databases.
Extensive knowledge of processes and procedures in clinical data management.
Proven successful project management skills.
Proven expertise in both Microsoft Office Suite, including advanced Excel and CDM (Clinical Data Management) systems.
Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives.
Ability to translate technical information to cross-functional teams.
Extensive knowledge of their own area within the organization while contributing to the development of new concepts, techniques, and standards.
Employment Type: Contractor