RAVE Programmer/Study Builder
Newark Metro Area, NJ
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 Company 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.