Senior Clinical Program Manager, Clinical Operations Compliance & Training GCP (P2512 and P3635)

Planet Pharma; Redwood City (CA); On-site; USD 180,000 - 230,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

Communication skills

Interpersonal skills

Analytical thinking

Education

RN

Bachelor’s

Master’s

Tools

MS Office Suite

MS Project

Smartsheet

Job description

The Opportunity: Senior Clinical Program Manager, Clinical Operations Compliance & Training

This is a unique opportunity for a Clinical Operations Compliance Professional. As a Sr. Clinical Program Manager (Sr. CPM), you will be in a key role in the Clinical Operations, Compliance and Training function in Clinical Operations to support the development and continuous improvement of GCP infrastructure using knowledge and experience with clinical study management, clinical compliance, clinical quality, International Conference on Harmonization (ICH) Guidelines, Good Clinical Practices (GCP) and regulatory requirements.

• Support Clinical Operations with GCP guidance and best industry practices.
• Lead or support the development and continuous improvement of Clinical Policies/ SOPs/ WIs/ Templates/etc. in compliance with International Conference on Harmonization (ICH) Guidelines, Good Clinical Practices (GCP) and regulatory requirements.
• Contribute to the management of business and compliance metrics to assess and continuously improve oversight and inspection readiness throughout the clinical trial lifecycle.
• Support Clinical Operations Inspection Readiness activities.
• Contribute to Clinical Operations training programs to deliver standards, GCP, and regulatory requirements.
• Partner cross-functionally and with QA on remediation plans and continuous improvement of GCP systems, investigations, CAPAs, and audit responses.
• Communicate deliverable status/issues, and problem solve to ensure functional goals are met.
• Use all available tools to track, oversee, and communicate on project status to all key stakeholders.
• Participate in other Clinical Operations Compliance & Training activities as assigned.

Required Skills, Experience and Education:

• RN or Bachelor’s or Masters degree in biological sciences or health-related field required.
• 10+ years (Sr. CPM) direct Clinical Operations and/or Clinical Compliance and/or Clinical Quality Assurance experience in the pharmaceutical or biotech industry or Clinical Research-related experience.
• Strong working knowledge of FDA Regulations, GCP, and ICH Guidelines, current industry practices.
• Demonstrated experience successfully developing and authoring Clinical and cross-functional SOPs ensuring compliance with GCP and regulatory requirements.
• Experience with development and monitoring of oversight activities.
• Thrives in a collaborative team setting that demonstrates flexibility required to maintain a fast pace and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment.
• Be solution-oriented by anticipating obstacles and difficulties, and proactively providing risk assessment and mitigation strategies to achieve project goals.
• Excellent written/verbal communication and interpersonal skills.
• High sense of priority and commitment to excellence in the successful execution of deliverables.
• Ability to analyze operational data, contribute with a mind on quality, timeliness and fiscal responsibility, make and drive decisions, multi-task, prioritize tasks, anticipate challenges, and execute on goals as a member of an interdisciplinary team.
• Demonstrate proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint); MS Project and/or Smartsheet a plus.
• Travel may be required (~25%).

Preferred Skills:

• Oncology experience, early and/or late stage.
• Knowledge and/or familiarity with Ex-US region(s) regulations and requirements.