Clinical Compliance/Inspection Readiness, Manager - Clinical Operations

Role Summary

Clinical Compliance/Inspection Readiness, Manager - Clinical Operations role focused on managing inspection preparedness, inspection support, clinical procedural development and maintenance, and training programs within a clinical operations context. Onsite position located at Gaithersburg, MD or Conshohocken, PA sites.

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
• Coordinate 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.)
• Assist with 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
• 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

Qualifications

• Essential: At least 8 years relevant experience in biotechnology/pharmaceutical industry and/or CRO with experience in compliance, quality, training or related clinical operations
• Essential: Expertise in global regulatory and compliance requirements for clinical research, including US CFR, EU GCP, ICH GCP
• Essential: Experience with performing PAI and Inspection readiness assessments
• Essential: Experience delivering high-level presentations, orally and in writing
• Essential: Demonstrated ability to work in a collaborative, multi-disciplinary team and manage tasks to completion
• Desirable: Prior experience with clinical auditing and clinical operations functions; compliance and training

Education

• BA/BS or higher in science-related field (biological sciences, medical, pharmacy or health-related discipline)
• 8+ years‚Äô experience in related area with some QA/Audit experience preferred
• Clinical Operations and/or Inspection Readiness experience preferred
• Proven computer skills: MS Word, Excel, PowerPoint, Outlook, MS Project, SharePoint

Additional Requirements

• Some international and local travel may be required (approximately up to 20% travel)