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Medidata Rave EDC Developer (Remote, US or Canada)

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Date: Nov 19, 2020

Location: Iselin, NJ, US Iselin, NJ, CA

Company: Cytel Inc

<span style="font-family:"Arial",sans-serif">Cytel provides unrivaled biostatistics and operations research knowledge to our customers in the life sciences industries in the form of both software and services.  At Cytel, we work hard to create successful careers with significant professional growth for our employees, as a result of which they work hard to make Cytel successful. Cytel is a place where talent, experience and integrity come together to advance the state of clinical development.


We are hiring a remote Senior Clinical EDC Developer to join our Clinical Research Services group leading and supporting EDC development initiatives for a small Biotech company specializing in Rare Diseases.  Excellent opportunity to make an immediate impact and help establish a framework for best practices and SOPs working with Medidata Rave and Veeva Vault systems.


Your Impact

•    System edit checks and custom functions as per sponsor SOP's, software best practices and applicable training
•    Participates in eCRF review meeting(s) during development with study team to ensure agreement with eCRF layouts and content.
•    Manages changes/corrections to issues discovered during UAT
•    Manages EDC development timelines with local data manager (LDM)
•    Conducts system quality control as per sponsor SOPs prior to release to user acceptance training (UAT)
•    Carries out migration of existing subjects to updated version of EDC (e.g. Rave Migration process)
•    Participates in EDC SOP development/revision with sponsor as applicable
•    Programs data cleaning listings and external data reconciliations
•    Creates ad hoc data outputs as needed for clinical trial data based on team needs
•    Participates in development of front-end data collection standards to help ensure compatibility with the standard data tabulation model (SDTM)


What we need from you:

•    Bachelor's degree in an IT or Biometric field
•    A minimum of 5 years of experience with Medidata Rave (Certified Rave Architect or equivalent highly desired), Rave Custom Function development (including programming edit checks and protocol set-up), Rave migrations and process development experience
•    Experience with Veeva Vault systems
•    Experience in Rave Amendment Manager and other Rave modules.
•    SAS programming experience required
•    Experience with C++, C#, SQL or other programming languages a plus
•    R/Python experience an advantage



Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.

Cytel does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Cytel’s human resources department to obtain prior written authorization before referring any candidates to Cytel. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Cytel. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Cytel. Cytel shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies.

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