Clinical Compliance/Inspection Readiness, Manager - Clinical Operations

About the role

This is an onsite position and can be located at either our Gaithersburg, MD or Conshohocken, PA sites.

Key responsibilities

• Lead the development and delivery of GCP and Inspection Readiness training for the Clinical organization
• Lead the development and implementation of processes and tools to support teams and functions in being inspection ready
• Provide ongoing inspection readiness support and expertise to study teams, including risk mitigation and monitoring
• Execute plans with clinical teams and cross-functionally to prepare for audits and regulatory agency inspections, including support of ongoing storyboarding
• Provide representation for the Clinical Compliance function in Sponsor audits and Regulatory Agency inspections, and supervise Clinical preparation room activities
• Cook up follow-up within the Clinical organization on all audits, inspection responses, commitments, post-inspection activities, and implementation of corrective and preventive actions (CAPA)
• Generate, analyze and communicate inspection readiness metrics
• Drive continuous improvement into inspection readiness and inspection conduct support
• Lead the development and approval of controlled documents related to clinical study processes and systems including Policies, SOPs, Work Instructions, forms and templates in compliance with global regulatory standards
• Lead the strategy execution for role-based curriculum and GCP training within the Clinical organization
• Collaborate with QA with the preparation/collection of all training documents in preparation for internal training file audit (e.g., completed SOP matrices, CVs, JDs etc.)
• Absorb, assess, and provide oversight and/or conduct compliance assessments including but not limited to vendor/contractor qualification assessments in collaboration with Quality Assurance
• Absorb, assess, and provide oversight and/or conduct compliance assessments including but not limited to vendor/contractor qualification assessments in collaboration with Quality Assurance
• Assist with management and oversight of the tracking of Suspected Serious Clinical Non-Compliance Issues (SSCNCI), including reporting (if applicable) and ensure follow-up and closure
• Support the completion of internal audit reports and collaborate with the Quality function(s) to assess process improvement and/or training needs and opportunities
• Manage follow-up within the Clinical organization on all audits, inspection responses, commitments, post-inspection activities, and implementation of corrective and preventive actions (CAPA)
• Track status of open Quality Issues and CAPAs and coordinate with Clinical stakeholders to ensure timely and adequate closure, as appropriate
• Generate, report, and respond accordingly to compliance/inspection readiness KPIs

Other duties

• Support and prepare internal and external clinical operations teams for audits
• Provide training on Clinical Standard Operating Procedures and Work Instructions to ensure compliance with regulatory organizations
• Support and manage in collaboration with Quality Assurance the clinical quality database observations
• Identify opportunities and provide leadership in continuous improvement of good clinical practices
• Establish and assure adherence to budgets, schedules, work plans, and performance requirements, relative to inspection readiness support and clinical compliance activities
• Regularly communicate with senior management or executive levels on matters regarding several functional areas

Experience & Knowledge

• Essential: At least 8 years relevant experience in a biotechnology/pharmaceutical industry and/or contract research organization (CRO) with experience in compliance, quality, training or related clinical operations function
• Essential: Expertise in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EUCTD, and ICH GCP
• Prior experience with the following would be an advantage: Clinical auditing and relevant clinical operations functions, Compliance and training

Education & Qualifications

• Bachelor's degree or higher in a science-related field (biological science, medical, pharmacy or other health-related discipline)
• 8+ years’ experience in related area with some experience in QA/Audit setting preferred
• Clinical Operations and/or Inspection Readiness experience preferred
• Demonstrated computer skills; proven functional knowledge of Microsoft packages (MS Word, Excel, Power Point, Outlook, MS Project, SharePoint)