Senior Clinical Ops, Compliance & Training Lead

Planet Pharma; Redwood City (CA); Sur place; USD 180 000 - 230 000; Plein temps

Résumé du poste

Planet Pharma is seeking a Senior Clinical Program Manager for Clinical Operations Compliance & Training in Redwood City, CA. This role leads GCP guidance, regulatory compliance, and SOP development across the clinical lifecycle, ensuring inspection readiness and quality oversight.

The ideal candidate has 10+ years in clinical operations or compliance, with strong knowledge of FDA regulations, GCP, and ICH guidelines, and excellent communication in a fast-paced biotech environment.

Qualifications

• Bachelor’s or higher in biological sciences or health-related field.
• 10+ years in Clinical Operations/Compliance/Quality Assurance.
• Strong knowledge of FDA regulations, GCP and ICH guidelines.

Responsabilités

• Support GCP guidance and industry best practices in Clinical Operations.
• Lead or support development and continuous improvement of Clinical Policies, SOPs, WIs and templates in line with GCP/regulatory requirements.
• Contribute to management of oversight metrics and inspect readiness across the trial lifecycle.
• Assist with Clinical Operations Inspection Readiness activities.
• Contribute to training programs delivering standards, GCP and regulatory requirements.
• Collaborate with QA on remediation plans and CAPAs, and audit responses.
• Communicate deliverable status and track project progress to stakeholders.

Connaissances

Communication skills

Interpersonal skills

Analytical thinking

Formation

RN

Bachelor’s

Master’s

Outils

MS Office Suite

MS Project

Smartsheet

Description du poste

Planet Pharma is seeking a Senior Clinical Program Manager for Clinical Operations Compliance & Training in Redwood City, CA. This role leads GCP guidance, regulatory compliance, and SOP development across the clinical lifecycle, ensuring inspection readiness and quality oversight.

The ideal candidate has 10+ years in clinical operations or compliance, with strong knowledge of FDA regulations, GCP, and ICH guidelines, and excellent communication in a fast-paced biotech environment.