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Associate Director, Clinical Compliance

Job summary

The Associate Director Clinical Compliance is responsible for the management and execution of activities associated with clinical procedural development and maintenance, clinical training programs, inspection preparedness, and assessment and investigation of clinical quality compliance issues.  This position is also responsible for management and execution of clinical vendor qualification assessments.

Essential job functions and duties

  • Manage and oversee development and approval of controlled documents related to clinical study processes and systems including Policies, SOPs, Work Instructions, forms and templates
  • Execute strategy for role-based training curriculum, GCP training and Inspection Readiness training for the Clinical organization
  • Oversee and/or conduct compliance assessments including but not limited to vendor/contractor qualification assessments
  • Manage and oversee the tracking of Suspected Serious Clinical Non-Compliance Issues (SSCNCI), including reporting (if applicable) and ensure follow-up and closure
  • Manage the review of internal audit reports and collaborate with the Quality function(s) to assess process improvement and/or training needs and opportunities.
  • Execute plans with clinical teams and cross-functionally to prepare for audits and regulatory agency inspections
  • Provide representation for the Clinical Compliance function in Sponsor audits and Regulatory Agency inspections, and supervise Clinical preparation room activities
  • Manage follow-up within the Clinical organization on all audits, inspection responses, commitments, post-inspection activities, and implementation of corrective and preventive actions (CAPA)
  • Plan, assign and direct work; manage, develop and support Clinical Compliance staff
  • Travel up to 20% may be required

 

Minimum requirements

  • Bachelor degree in scientific/medical/pharmaceutical discipline or equivalent is required.
  • 8 years pharmaceutical industry experience with at least 5 years in compliance, quality, training or related clinical operations function.  Prior experience with both clinical auditing and operations is required.
  • Working knowledge of ICH GCP, FDA Regulations and EU Clinical Trial Directives; thorough knowledge of the drug development process.  ISO guidelines and device experience a plus.
  • Strong partnering and collaboration skills.  Ability to work with different functional areas within the company and accomplish goals in a matrix environment.
  • 5+ years of line management experience, including management, development and mentoring of assigned staff members.
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