Lead Data Manager
Chiltern International - New Jersey

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· Data Manager required for global pharmaceutical company based in Princeton, NJ area
· Position is office-based on-Site for 6-9 months.
· Act as Lead Data Manager on assigned projects; represent the organization in providing solutions to difficult technical issues associated with specific projects
· Excellent opportunity to work for a global pharma company
· Candidates must have current legal work authorization to work for any company in the United States

·Act as Lead Data Manager on assigned projects; represent the organization in providing solutions to difficult technical issues associated with specific projects
· Interact both verbally and through written communication with inter-organizational and outside customer contacts as well as with Central and External laboratories, CROs, etc.
· Contribute to the design of protocols
· Develop eCRF specifications according to protocol and approved standards (based on industry standards), participate in user acceptance testing
· Develop protocol specific edit check specifications, participate in user acceptance testing
· Develop and maintain project- specific Data Management plan throughout the life-cycle of the study protocol, which includes CRF annotation, database specifications, edit checks and other pertinent data management documents
· Provide training for team members in data management procedures
· Prioritize tasks with respect to pre-determined timelines
·Provide direction and coordinate data management activities to ensure timely database lock and release of data for interim and final analyses
· Provide oversight, monitor and track quality of vendor data management deliverables, ensuring audit practices are in place to validate the quality of EDC database content as well as external electronic data transfers
· Perform metrics on data management processes and guidelines to evaluate efficiency, accuracy, and speed in cleaning clinical study data and locking database for study reporting
·Ensure data processing activities are performed according to protocol, GCP and SOPs

Requirements

Job Qualifications

· 6+ years clinic al data management experience
· 2+ years experience with Medidata Rave
· BS or BA degree in a life scientific area / technical discipline preferred
· Thorough understanding of clinical data management methodology
· Experience with CDISC/CDASH and standard coding dictionaries (e.g., MedDRA and WHODRUG)
· Knowledge of clinical database design (either in Rave or SAS) and remote data entry technology
· Proficiency in Microsoft Windows and Office.

Chiltern International - 19 months ago - save job - block
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