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Scientific. Clinical. Software Engineering

RAVE Programmer/Study Builder

Newark Metro Area, NJ

Job Type: Scientific Job Number: JN -062020-27011 Region: Newark Metro Area

Job Description

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.

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