Clinical Compliance/Inspection Readiness, Manager - Clinical Operations

Role Summary

Clinical Compliance/Inspection Readiness, Manager - Clinical Operations. Location: Conshohocken, PA or Gaithersburg, MD. Onsite role responsible for inspection preparedness, inspection support, clinical procedural development and maintenance, clinical training programs, and assessment/investigation of clinical quality compliance issues.

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
• Assist with oversight and/or conduct compliance assessments including 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 and follow-up

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 (US CFR, EU CTD, ICH GCP)
• Essential: Demonstrated continuous professional development mindset
• Essential: Experience performing PAI and Inspection readiness assessments; ability to deliver high-level presentations both orally and in writing
• Desirable: Prior experience in clinical auditing and relevant clinical operations functions; compliance and training
• Education: BA/BS or higher in science-related field (biological science, medical, pharmacy or health-related discipline)
• 8+ years‚Äô experience in related area with some QA/Audit exposure preferred; Clinical Operations and/or Inspection Readiness experience preferred
• Computer skills: MS Word, Excel, PowerPoint, Outlook, MS Project, SharePoint

Skills

• Strong analytical and communication skills
• Ability to work collaboratively in a multi-disciplinary team
• Project management and leadership capabilities
• Problem-solving and CAPA management

Education

• BA/BS or higher in science-related field

Additional Requirements

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