Job Information
Just in Time GCP Consultant in Warrington, Pennsylvania
What you will do -- Highlights of Responsibilities include:
- Participate in projects related to GCP compliance, implementation of optimized Trial Master File oversight frameworks, Sponsor oversight gap assessment, process redesign & optimization, and inspection readiness
- Using your knowledge of clinical operations, participate gap assessments in both GCP compliance and operational efficiency to establish organizational current state
- Leverage your knowledge of the drug development process and regulatory inspection trends/findings to help organizations develop the people, processes, and technology that drives GCP compliance and regulatory inspection preparation
- Leverage your understanding of applicable regulations and risk management to support organizations in right sizing and prioritizing their remediation of gap findings
- Develop training as required by project scope of work
- Participate in process mapping activities with clients to develop processes that are in alignment with client needs and remain compliant with GCP requirements
- Participating in internal process improvement effort
To succeed in this position, the ideal candidate would have:
- Undergraduate degree and minimum of 7 years' experience in life sciences consulting or clinical operations, or equivalent combination of education and experience; graduate degree preferred or equivalent combination of education and experience
- Experience with global (domestic and international) regulatory and ethics requirements, and industry best practices
- Experience supporting risk-based Clinical Quality Assurance activities (e.g., risk assessment, GCP auditing, CAPA authoring/remediation)
- Experience with the drug development process and clinical trial conduct
- Experience supporting regulatory agency inspections
- Experience drafting procedures/QMS documents (e.g., Manuals, Policies, SOPs) and tools/guidelines/QRCs
- Experience preparing presentations and/or visualizations that effectively tell a story, particularly as applied to client deliverables and project management