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Clinical Programmer Analyst - Nutley, United States - System One
Description
Job Title: Clinical Programmer Analyst
Location: Remote - Must be US Based
Compensation: $55.00- $60.00
Type: 12 month Contract - 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.
System One, and its subsidiaries including Joul, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
