Job Description

Associate Director, Clinical Operations Compliance

W2 Contract

Salary Range: $166,400 - $176,800 per year

Location: Redwood City, CA - Onsite Role

Job Summary:

As an Associate Director contractor, you will play a key role within Clinical Operations and provide compliance support for sponsored clinical trials concerning Standard Operating Procedures, applicable regulatory requirements (FDA, EU, ICH & country-specific), and current industry standards and practices.

Duties and Responsibilities:

• 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 to remediate quality issues and implement continuous improvement initiatives.
• Perform quality review of clinical trial documents focusing on compliance, regulatory requirements, and risk management.
• Support Inspection Readiness activities (e.g., TMF activities, study documentation).
• Provide strategic quality operational guidance to ensure clinical trials are properly defined, planned, and executed across all assigned clinical-stage programs through tracking, creation, deployment, and management of systems, processes, procedures, training programs, GCP compliance, and regulatory inspection-readiness activities.
• Perform other assigned Clinical Operations Compliance or GCP activities, as appropriate.

Requirements and Qualifications:

• RN, bachelor's, or master's degree in biological sciences or health-related field is required.
• 8+ years of 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 the ability to interact with colleagues and partners at all levels of experience
• Comfortable in a fast-paced company environment and able to adjust workload based on changing priorities
• Demonstrated proficiency in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint, Visio); Microsoft Project and/or Smartsheet a plus.
• Travel may be required (~25%).
• Familiarity working with vendor systems/portals (eTMF, EDC, IRT, CTMS) is a plus.
• Oncology experience, early and/or late stage, is strongly preferred.
• Knowledge and/or familiarity with Ex-US region(s) clinical trial operations is preferred.

Desired Skills and Experience

Clinical Operations, Clinical Quality Assurance, SOP, GCP compliance, FDA Regulations, ICH Guidelines, Oncology, Microsoft Office, eTMF, EDC, IRT, CTMS

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.

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