Rave Study Builder

Please send the resumes to careers@starkassociatesllc.com or

Contact: +1 848-300-0022

Job Title: Rave Study Builder

Location: Summit, NJ or California

Duration: Long Term

Responsibilities

• 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 Celgene 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.