What you will do -- Highlights of Responsibilities include:

1. 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
2. Using your knowledge of clinical operations, participate gap assessments in both GCP compliance and operational efficiency to establish organizational current state
3. 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
4. Leverage your understanding of applicable regulations and risk management to support organizations in right sizing and prioritizing their remediation of gap findings
5. Develop training as required by project scope of work
6. Participate in process mapping activities with clients to develop processes that are in alignment with client needs and remain compliant with GCP requirements
7. Participating in internal process improvement effort

To succeed in this position, the ideal candidate would have:

1. 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
2. Experience with global (domestic and international) regulatory and ethics requirements, and industry best practices
3. Experience supporting risk-based Clinical Quality Assurance activities (e.g., risk assessment, GCP auditing, CAPA authoring/remediation)
4. Experience with the drug development process and clinical trial conduct
5. Experience supporting regulatory agency inspections
6. Experience drafting procedures/QMS documents (e.g., Manuals, Policies, SOPs) and tools/guidelines/QRCs
7. Experience preparing presentations and/or visualizations that effectively tell a story, particularly as applied to client deliverables and project management