What you will do -- Highlights of Responsibilities include:

1. Lead 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, perform gap assessments in both GCP compliance and operational efficiency to establish organizational current state
3. Leverage your expertise in 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 and present 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. Support the growth of company revenue and Consulting Services by leveraging your professional network and through attendance at national meetings, participating in sales calls, and developing proposals.
8. Represent the company by presenting at webinars and national meetings
9. Participating in internal process improvement efforts

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

1. Undergraduate degree and minimum of 12 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 leading teams and  developing staff
3. Experience with global (domestic and international) regulatory and ethics requirements, and industry best practices
4. Experience supporting risk-based Clinical Quality Assurance activities (e.g., risk assessment, GCP auditing, CAPA authoring/remediation)
5. Experience with the drug development process and clinical trial conduct
6. Experience supporting regulatory agency inspections
7. Experience assessing cross-functional considerations in developing bespoke future state strategies
8. Experience drafting procedures/QMS documents (e.g., Manuals, Policies, SOPs) and tools/guidelines/QRCs
9. Experience preparing and finalizing presentations and/or visualizations that effectively tell a story, particularly as applied to client deliverables and project management
10. Experience with client/account management and project management methodologies

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