Hiring for EDC Database Programmer for Edison, NJ

Hi
Please lookup the below position and if you feel comfortable ,then please send me your updated resume

Role                       :              EDC Database Programmer
Location               :              Edison, NJ

Duration              :              6+ Months with likely extensions

Interview            :              Phone and Skype (local candidates will given preference for face to face )

 

Job Description

·         The EDC Database Programmer is a member of the Biostatistics and Data Management team and provides EDC expertise and solutions in collaboration with the CRO partner and DM teams.

·         Provides technical expertise, guidance and best practices to DM, Clinical teams and other stakeholders. Serves as a subject matter expert and provides expertise for problem-solving with EDC capabilities and functionality.

Job Requirement

• Minimum of 6 years EDC and clinical programming experience in the biotech/pharmaceutical/ CRO industry.
• EDC RAVE experience
• Knowledge of CDISC, CDASH and SDTM is a must.
• Knowledge of reporting tools: JReview, Spotfire, BOXI/BO4 are preferred.
• Experience with database development using EDC validation, execution, maintenance, documentation, and archival of clinical data for regulatory submission is required.
• Proficient in industry standards and data management processes.

Job Responsibilities

• As SME for EDC between Data Management, CRO partners, and business stakeholders responsible to address escalation of study specific functional issues, tool issues, enhancement requests, custom functions and/or custom reports.
• Provide expertise and guidance to lead the development, maintenance, and compliance of database builds and EDC standards in support of clinical studies including, but not limited to, Global Library, Edit Checks, CRF modules and Standard/Custom Reports.
• Provides EDC technical support to facilitate clinical study timelines and deliverables in collaboration with DM and CRO.
• Manage external vendors and ensure accurate and high-quality deliverables.
• Serve as the EDC Administrator role to support operational deliverables under Study Set Up, Study Maintenance, Study Conduct and Study Close Out.
• Review deliverables before transfer to either internal or external clients.
• Review annotated case report forms and database structures.
• Manages timely and quality deliverables to the Study Teams, Management and other Stakeholders
• Supports DM initiatives as necessary

 

 

 

 

Regards ,

Kailash Negi

VSG Business Solutions

221 Cornwell Dr Bear, DE 19701

Email ID : kailash@vsgbusinesssolutions.com

Phone: 302-261-3207 x 102

 

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