• Provide EDC Services for projects including Protocol Conversion, Database Build, eCRF design, Edit Checks design and related EDC component s
• Provide Data Management Services for projects including Data Verification, Data Review, Query Management, Coding, External Data Reconciliation, SAE Reconciliation and related tasks
• Collaborate with the project team to ensure the deliverables are completed on time with high quality
• Provide Quality Control on deliverables developed by other team members including Review Report specifications and Clinical Data Repository (CDR) deliverables
• Maintain or provide input to all required Study Documents including Data Validation Specifications, Data Management Plan as required by SOP and Processes
• Work on consulting efforts related to systems including UAT, global library and standards development, implementation of Client CDRs
• Ensure compliance with clinical Solutions and industry quality standards, regulations, guidelines, and procedures
• Other duties as assigned

Requirements:

• Bachelor of Science degree in health-related field ; Master's in science preferred
• 6 years' experience in Clinical Data Management or equivalent preferred
• Minimum 2 years in Pharmaceutical and/or Biotechnology industry or equivalent consulting role preferred
• Strong knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology
• Experience performing data management activities, EDC experience a plus
• Detail oriented, ability to multitask with strong prioritization, planning and organization skills
• Proficiency in Microsoft Office Applications
• Strong familiarity with EDC and Clinical Data Management Systems: Rave, Inform,CLIN trial, or Oracle Clinical preferred
• Experience with Data Reporting Tools: Business Objects, Review, Cognos or related preferred.