Associate Director, Clinical Operations Compliance

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.

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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