Sr. Clinical Program Manager (Inspection Readiness)

Clindata Insight Inc; San Francisco (CA); Hybrid; USD 138,000 - 165,000; Full time

Job summary

Clindata Insight Inc. is seeking a senior Clinical Operations compliance professional to support GCP guidance and improve SOPs, WIs, and templates per GCP/ICH standards.

The role focuses on strengthening inspection readiness across the trial lifecycle and preparing inspection storyboards for global submissions. The candidate will partner with QA on CAPAs, audit responses, and GCP system remediation, and will deliver training on GCP and regulatory standards.

Qualifications

• RN or degree in biological sciences or health-related field
• 10+ years in Clinical Operations, Clinical Compliance, or Clinical QA in pharma/biotech
• Hands-on CAPA management and inspection storyboard development experience
• Authorship of GCP-compliant Clinical and cross-functional SOPs
• Rate $100-$120/hr 40 hrs/wk; based on experience and proficiency

Responsibilities

• Support Clinical Operations Compliance with GCP guidance and industry best practices
• Lead development and improvement of Clinical SOPs, WIs, and templates per GCP/ICH standards
• Manage compliance metrics to strengthen inspection readiness across the trial lifecycle
• Prepare inspection storyboards and lead FDA BIMO pre-approval inspection readiness for global submissions
• Partner with QA on CAPAs, audit responses, and GCP system remediation
• Deliver Clinical Operations training on GCP and regulatory standards

Skills

Clinical Operations

Regulatory compliance

GCP knowledge

CAPA management

SOP development

Inspection readiness

Education

Bachelor's or Master's in biological sciences or health-related field

RN credential

Job description

• Support Clinical Operations Compliance with GCP guidance and industry best practices
• Lead development and improvement of Clinical SOPs, WIs, and templates per GCP/ICH standards
• Manage compliance metrics to strengthen inspection readiness across the trial lifecycle
• Prepare inspection storyboards and lead FDA BIMO pre-approval inspection readiness for global submissions
• Partner with QA on CAPAs, audit responses, and GCP system remediation
• Deliver Clinical Operations training on GCP and regulatory standards

What You Bring

• RN, or Bachelor's/Master's in biological sciences or health-related field
• 10+ years in Clinical Operations, Clinical Compliance, or Clinical QA in pharma/biotech
• Hands-on CAPA management and inspection storyboard development experience
• Proven authorship of GCP-compliant Clinical and cross-functional SOPs
• $100-$120/hr 40 hrs/wk Rate based on level, specific experience, and technical proficiency

Note: Direct applicants only, no agencies. Strongly prefer Bay Area candidates able to work onsite in Redwood City 2 days/week.