Senior Clinical Compliance & Ops Strategy Consultant – Remote
Just In Time GCP
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Benefits offered by this job
Job summary
Just in Time GCP in the United States seeks a Strategic Consultant, Clinical Compliance & Operational Excellence with 10–12 years in clinical operations and consulting. You will lead GCP compliance engagements, advise on ICH and Health Authority requirements, and steer inspection readiness for biotech and pharma sponsors.
As a senior SME, you will mentor consultants, shape methodologies, deliver training programs, and drive quality improvements.
Qualifications
- Bachelor’s degree required; advanced degree preferred.
- 10–12 years in clinical operations, compliance, and/or consulting.
- Experience advising on GCP and inspection readiness.
- Knowledge of ICH, GCP, 21 CFR Part 11, Annex 11 and global regulatory frameworks.
Responsibilities
- Lead complex engagements on GCP compliance and inspection readiness.
- Provide regulatory direction across programs as SME.
- Oversee development and quality of project deliverables.
- Design and deliver GCP training programs for client teams.
- Mentor consultants and guide project execution.
- Support business development through proposals and client engagement.
Skills
Education
Job description
Just in Time GCP in the United States seeks a Strategic Consultant, Clinical Compliance & Operational Excellence with 10–12 years in clinical operations and consulting. You will lead GCP compliance engagements, advise on ICH and Health Authority requirements, and steer inspection readiness for biotech and pharma sponsors.
As a senior SME, you will mentor consultants, shape methodologies, deliver training programs, and drive quality improvements.
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