Job Title: Clinical Programmer Analyst

Location: Remote - Must be US Based

Compensation: $55.00- $60.00

Type: 12 monthContract - W2 only - Please not agencies

Responsibilities

• Senior Rave Programmer Responsible for designing the eCRF in leading EDC systems in Rave
• Technical expertise, technical writing ability, and proficiency in Systems Development LifeCycle (SDLC) principles.
• Provide technical support and troubleshooting for Rave study development as well as site management and user access within supported RAVE modules
• Serve as system administrator to grant user access using iMedidata Cloud Administration for RAVE EDC, Coder, Lab Admin, RTSM and MMI (Imaging) provide Oversight, guidance, and design of study build activities on Rave URL.
• Create Advanced Analytics dashboards
• Insights into creating actionable dashboards and deep understanding and knowledge of good interpretation of clinical data
• Responsible for the preparation and /or review draft and final eCRF, edit check specifications for assigned projects to ensure quality and consistency
• Responsible for conducting Quality Control of study design for assigned projects and participate in the validation of EDC studies
• Responsible for the creation and maintenance of library objects within the Global Libraries
• Responsible for ensuring compliance of standard objects usage throughout the business
• Responsible for the management of standard objects within the Global Libraries
• Perform all activities related to specification development for study build and design of databases according to Standard procedures
• Responsible for the review and approval of derivations and edit checks requested by the project teams
• Participate in the development of global, harmonized SOPs and specific quality work instruction for technical service group activities
• Complete work according to Eisai SOPs, Work Instructions and project specific guidelines in accordance with Good Clinical Practice

Requirements

• Minimum 10 years of relevant work experience to include data management and/or database programming and spec Design activities including 10 years in Medidata RAVE
• Strong Programming skill set
• Knowledge of Python, building dashboards
• Knowledge of API programming
• Demonstrate excellent problem-solving skills, a proactive approach and the ability to make sound decisions
• Demonstrated skill in leading teams, by example and mentoring staff
• Excellent oral and written communication and presentation skills
• Knowledge of clinical trial process and data management, CRF/eCRF Design, CDISC. Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical /biotechnological companies
• Demonstrated ability to work in a team environment
• Demonstrated ability to handle multiple competing priorities
• Proven interpersonal skills

Benefits

System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.