ob summaryThe Associate Director Clinical Compliance is responsible for the management and execution of activities associated with the development, revision and maintenance of clinical research procedural documents, clinical research training programs, regulatory inspection readiness, and assessment and investigation of clinical research compliance issues. This role will also assist Clinical Operations and/or Clinical Quality Assurance as needed during vendor qualifications, audits, regulatory inspections, and/or oversight 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
- Conduct and/or participate in compliance assessments and/or audits including but not limited to vendor/contractor qualification assessments
- Lead, manage and oversee the tracking of Serious Clinical Non-Compliance Issues (SINC), including reporting (if applicable), and ensure follow-up and closure
- Participate in the review of internal audit reports, mentor Clinical Operations staff in appropriate responses, 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 regulatory agency inspections
- Provide representation for the Clinical Compliance function in Sponsor audits and Regulatory Agency inspections, and supervise Clinical preparation room activities, as assigned
- Manage, mentor and follow-up within the Clinical organization on all audits, inspection responses, commitments, post-inspection activities, and implementation of corrective and preventive actions (CAPA)
- Assist in planning, and assign and direct work; manage, develop and support Clinical Compliance staff
- Travel up to 20% may be required
- Bachelor degree in scientific/medical/pharmaceutical discipline or equivalent is required.
- 8 years pharmaceutical industry experience with at least 5 years in clinical compliance, clinical quality assurance, clinical training or related clinical operations functions. Prior experience within clinical compliance or auditing, and clinical operations is required.
- Working knowledge of ICH GCP, FDA Regulations and EU Clinical Trial Directives/Regulations; 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.
Associated topics: clinical, dietician, food, healthcare, medicine, metabolism, nutrition, patient, therapeutic, therapy