- Title: Clinical Programmer
- Code: RCI-9581
- Location: Berkeley Heights New Jersey (NJ) 07922
- Posted Date: 06/30/2020
- Duration: 12 Months
- Name:Mittal Mandavia
- Email: email@example.com
- Phone: 908-704-8843 ✖ 245
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.