Senior Clinical Program Manager, GCP Compliance & Training

Planet Pharma; Redwood City (CA); On-site; USD 130,000 - 180,000; Full time

Job summary

Planet Pharma is seeking a Senior Clinical Program Manager to strengthen Clinical Operations Compliance and Training in our GCP framework. The role focuses on guidance, policy development, and inspection readiness to ensure regulatory adherence across trials.

The ideal candidate has extensive experience in FDA regulations, ICH guidelines, and cross-functional collaboration to drive continuous quality improvement in a fast-paced environment.

Qualifications

• RN or Bachelor’s or Master’s degree in biological sciences or health-related field.
• 10+ years of direct Clinical Operations and/or Clinical Compliance/Quality Assurance experience.
• Strong working knowledge of FDA Regulations, GCP, and ICH Guidelines.

Responsibilities

• Support GCP guidance and best industry practices in Clinical Operations.
• Lead or support development and continuous improvement of Clinical Policies/SOPs/WIs/Templates per ICH/GCP and regulatory requirements.
• Manage and improve oversight and inspection readiness across the clinical trial lifecycle.

Skills

Clinical Operations

Regulatory compliance

GCP knowledge

SOP development

Communication skills

Data analysis

Project management

MS Office proficiency

Education

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

Tools

MS Office Suite

MS Project

Smartsheet

Job description

Planet Pharma is seeking a Senior Clinical Program Manager to strengthen Clinical Operations Compliance and Training in our GCP framework. The role focuses on guidance, policy development, and inspection readiness to ensure regulatory adherence across trials.

The ideal candidate has extensive experience in FDA regulations, ICH guidelines, and cross-functional collaboration to drive continuous quality improvement in a fast-paced environment.