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Rave Study Builder

US Tech Solutions

This is a Contract position in Berkeley Heights, NJ posted April 2, 2020.

Job Title: Rave Study Builder Location: Seattle WA or Berkeley Heights NJ Duration: 12 months Job Details: Responsibilities include, but not limited to:
• Rave global library and edit check programming (including best practices, efficiencies and reusability)

• Develop, program, test and maintain global edit checks;
• Manages library studies and associated objects used for study configuration which have been approved through governance;
• Facilitates discussion for identification of objects which will be used for study configuration;
• Supports Disease Indication, Therapeutic and Franchise scientists from various therapeutic functions to proactively create new commonly used CRF’s and edit checks which could be consumed by study;
• Helps Global Librarian to maintain various EDC libraries;
• Maintains consistency between Rave Libraries and MDR and/or other standards (if applicable);
• Interact with CPs to confirm understanding of client Library for consistent study consumption;
• Liaison with the standard governance organization to maintain alignment with the business and proactively look for opportunities to build efficiencies;
• Manages risk mitigation, issue resolution and escalation related to Rave Global Libraries;
• Provide guidance for resolving Library capability concerns raised; Knowledge, Skills & Abilities (KSA’s): BASICALLY looking for a RAVE programmer.

• Good communication skills-ability to work in a team environment with data managers, medical personnel, clinical monitors, statisticians, programmers;
• Strong adherence to timelines and comfortable with escalating deadlines if necessary.

• Must be comfortable with speaking up and applying their own experience of best practices.

• BS/BA degree or equivalent in a relevant scientific discipline with a minimum of five years’ experience.

• Experience with one or more of Rave Modules: Coder, CSA, Patient Cloud, Safety Gateway, Site Payments, TSDV desired.

• Good communication skills; ability to work in a team environment with data managers, medical personnel, clinical monitors, statisticians, programmers, and medical writers.

• Knowledge of FDA/ICH guidelines and industry standard practices regarding programming.

• Medical or mathematics/computer science background a plus.

• Detailed knowledge and experience in case report form design, data validation.

• Knowledge of clinical trial design and basic statistics a plus.

• Experience in C# programming a plus.