Posted to MedZilla on 11/16/2018

Takeda Pharmaceuticals

US-MA, SEND Coordinator/Data Management Quality Control R0002618-MZ


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Job Description

  • Reporting to the Quality Control Manager, the SEND Coordination/Data Management QC Senior Associate will lead Standard for Exchange of Nonclinical Data (SEND) initiatives and operational work processes to optimize and support SEND regulatory submissions
  • Generate SEND datasets utilizing Takeda electronic data collection systems and QC SEND datasets received from CROs
  • Review and quality control (QC) nonclinical documents (protocols, amendments, reports, appendices, and tabulated summaries) for completeness, accuracy, and consistency, assist in managing report QC KPIs
  • Lead/ SEND/CDISC initiatives and participate in the continued implementation/upgrade of SEND and SEND related activities.
  • Participate and be active in the SEND Consortium and FDA/PhUSE Working Group
  • Maintain report quality metrics of nonclinical reports generated by Contract Research Organizations (CROs).
  • Lead Quality Metrics (KPIs) meetings, recommend and implement improvements.
  • Effectively interact and collaborate with Study Monitors, Project Team Representatives, and cross-functional teams; (i.e., Quality Assurance, Nonclinical Writing and Documentation) and CROs
  • Consistently meet study-related milestones and timelines
  • Minimum of BS in a scientific discipline and/or 2+ years of industry experience, working at a pharmaceutical company and/or CRO
  • Strong working knowledge of CDISC and SEND Implementation Guide (SENDIG)
  • Knowledge of FDA Good Laboratory Practice (GLP) Regulations as set forth in 21 CFR Part 58, OECD and ICH guidelines
  • Knowledge of the design and conduct of nonclinical studies
  • Attention to detail and experienced with review and quality control of nonclinical study data and reports
  • Work independently to achieve objectives in a timely manner
  • Strong interpersonal and organizational skills
  • Excellent communication skills and can effectively communicate both internally and externally
  • Proficiency with Microsoft Word, Microsoft Excel, and other common electronic systems
  • Previous work experience at a CRO desirable

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