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Director, Clinical and Quality Systems

  • Job type: Permanent
  • Location: Norwood, Massachusetts
  • Salary: Negotiable
  • Job reference: 224711/002_1539371574
  • Sector: Quality Assurance, EPM Scientific
  • Date posted: 12/10/2018

Position: Director, Clinical and Quality Systems

Location: Norwood, MA

Primary Functions of the Director, Clinical and Quality Systems:

  • Manage infrastructure and resources to meet the IS needs of the Organization

  • Identify long-term, scalable, practical solutions through cross functional work with growing aspects of the organization

  • Establish long-term and multi-discipline long-term partnerships with colleagues for state-of-the-art solution creation

  • Implement, maintain and enhance integrity of clinical data and clinical software systems as progressions through clinical trials continue

Primary Responsibilities of the Director, Clinical and Quality Systems:

  • Lead the development and maintenance of the Corbus IS system, focusing specifically on clinical software date to ensure compliance with all applicable regulations, guidance and GxP

  • Develop and lead a team of high-quality IS professionals through fostering a culture of collaboration, coaching, support and mentoring while successfully translating business requirements into individual goals, objectives and team deliverables

  • Establish controls and processed in support of data security, SOX and other relevant regulatory requirements to oversee contingency planning, IT security and Compliance

  • Manage all purchasing of IT equipment, IT services and IT budgets

  • Maintain all databases and documentation systems that support Clinical Operations

  • Advise, guide development on, deploy and support Clinical Systems, Document Management Software and ERP Systems

  • Support GxP Computer System Validation Projects and System Development Life Cycle Projects in Quality Assurance

  • Manage IS document management function, IS strategy, application roadmap, and project portfolio and R&D functions e.g., lab and research informatics solutions (ELN, LIMS, CDS, Compound registration/ inventory, Assay data management, SAR, PK/PD)

  • Manage clinical informatics (EDC, Data Management, eTMF, RIM, Adverse Event, SAS)

  • Manage Quality Solutions (QMS, LIMS)

  • Develop, track and regulatory report metrics around key performance indicators (KPI's)

  • Oversee SOX and other regulatory activities

Primary Qualification of the Director, Clinical and Quality Systems:

  • Prior experience as a leader, defining and delivering IS solutions to Corporate, R&D and Quality Professionals in the Life Sciences setting

  • Previous work experience in the Life Sciences Industry

  • Ability to select, implement, manage and sup[port key initiatives and systems such as clinical systems, document management software, ERP and Quality Management Systems (QMS)

  • Experience with solutions supporting discovery through preclinical and clinical development

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