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Associate Director, Clinical Operations Compliance - GCP

Redwood City, CA 94063

Posted: 04/18/2025 Employment Type: Contract Job Category: Clinical Development and Operations Job Number: 618697 Is job remote?: Yes Country: United States

Job Description


 Associate Director, Clinical Operations Compliance - Contractor GCP

The Opportunity:

Seeking a Contractor -  Associate Director, Clinical Operations Compliance, who will play a key role within Clinical Operations and is responsible for providing compliance support for sponsored clinical trials with respect Standard Operating Procedures, applicable regulatory requirements (FDA, EU, ICH & country-specific), and current industry standards and practices.

  • Support the development, revision and maintenance of applicable SOPs, processes and procedures that comply with applicable GCP standards and guidelines to support inspection readiness.

  • Identify and provide recommendations to mitigate risks to clinical study processes.

  • Be the SME for Clinical Operations personnel for issues relating to GCP, SOPs, non-compliance surveillance, Quality Events, audit/inspection responses and process optimization.

  • Partner with Clinical Operations and QA on remediation of quality issues and implementation of continuous improvement initiatives.

  • Perform quality review of clinical trial documents with a focus on compliance / regulatory requirements and risk management.

  • Provide support for Inspection Readiness activities (e.g., TMF activities, study documentation).

  • Provide strategic quality operational guidance to ensure that clinical trials are properly defined, planned, and executed across all assigned clinical stage programs through tracking, creation, deployment, and management of systems, process and procedures, training programs, GCP compliance, and regulatory inspection-readiness activities.

  • Other assigned Clinical Operations Compliance or GCP activities, as appropriate.

Required Skills, Experience and Education:

  • RN or bachelor’s or master’s degree in biological sciences or health-related field required.

  • A minimum of 8 years in GCP Quality and/or Clinical Operations experience in the pharmaceutical or biotech industry. Relevant indirect experience may also meet this requirement.

  • Experience in Quality Assurance, SOP writing, inspection readiness, CAPA preparation and successful closure.

  • Intimate working knowledge of FDA Regulations, ICH Guidelines, and GCP related to late stage or post marketed products.

  • Ability to bridge the gap between different interdisciplinary departments, and provide guidance on a compliant clinical development operations structure and team.

  • Ability to deal with time demands, incomplete information, or unexpected events.

  • Outstanding organizational skills with the ability to multi-task and prioritize.

  • Excellent interpersonal, verbal, and written communication skills, with ability to interact with colleagues and partners at all levels of experience are expected.

  • Comfortable in a fast-paced company environment and able to adjust workload based upon changing priorities.

  • Demonstrated proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint, Visio); MS Project and/or Smartsheet a plus.

  • Travel may be required (~25%).

Preferred Skills:

  • Has familiarity working with vendor systems/portals (e.g., eTMF, EDC, IRT, CTMS)

  • Oncology experience, early and/or late stage, strongly preferred.

  • Knowledge and/or familiarity with Ex-US region(s) clinical trial operations.

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Redwood City, CA

Ready to embark on an exciting career opportunity in the vibrant area around Redwood City, California? Nestled in the heart of Silicon Valley, this thriving region offers a perfect blend of innovation, growth, and charm. From the bustling tech scene to the serene beauty of Redwood City's parks, like Edgewood Park and Pulgas Ridge Preserve, there's something here for everyone. Immerse yourself in the local culture by visiting the Fox Theatre or exploring art galleries like The Art Center and Redwood City Art Kiosk. With a bustling food scene offering everything from trendy cafes to authentic Mexican cuisine, it's no wonder that Redwood City is a top choice for job seekers looking to thrive in a dynamic environment. Browse our job listings today and take the next step towards a fulfilling career in this captivating locale!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.