Global Phase 3 Study Lead - Clinical Program Manager

Planet Pharma; South San Francisco (CA); On-site; USD 190,000 - 230,000; Full time

Job summary

Planet Pharma is seeking a Clinical Project Manager – Global Study Lead (Contract) in California. The role anchors operational planning, execution, and oversight for a large global Phase 3 study, partnering with Senior Director and cross-functional teams to ensure study success.

You will manage start-up through closeout, oversee CROs, and drive timelines, risks, and performance while maintaining inspection readiness and regulatory compliance.

Qualifications

• 8+ years of clinical research experience.
• Experience leading global Phase 3 studies or programs.
• Knowledge of FDA/EMA regulations and ICH-GCP.

Responsibilities

• Act as Global Study Lead and primary Clinical Operations contact from start-up to closeout.
• Lead global study planning including start-up, enrollment, site management, and CRO collaboration.
• Oversee CROs and vendors, aligning timelines, deliverables, quality, risks, and performance.
• Partner with cross-functional teams to drive study execution and mitigate risks.
• Develop and manage study timelines, enrollment projections, budgets, and metrics.
• Provide regular progress updates to stakeholders and leadership.
• Review study documents and supervise monitoring activities and study data integrity.
• Support inspection readiness and regulatory compliance (ICH-GCP, SOPs).
• Provide functional leadership to Clinical Operations staff as needed.

Skills

Global Phase 3 leadership

CRO/vendor oversight

FDA/EMA regulations knowledge

ICH-GCP knowledge

Cross-functional collaboration

Travel ability

MS Office proficiency

Education

BS/BA/BN in scientific discipline

RN certificate (2–3 year)

Job description

Planet Pharma is seeking a Clinical Project Manager – Global Study Lead (Contract) in California. The role anchors operational planning, execution, and oversight for a large global Phase 3 study, partnering with Senior Director and cross-functional teams to ensure study success.

You will manage start-up through closeout, oversee CROs, and drive timelines, risks, and performance while maintaining inspection readiness and regulatory compliance.