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 : kail...@vsgbusinesssolutions.com
<kail...@vsgbusinesssolutions.com>*

*Phone: 302-261-3207 x 102*

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