Job Description

Minimum 6 month contract - potential for conversion to FTE

Exciting opportunity with a key client in the Oncology space. We are looking for someone with experience in GCP Quality and Clinical Operations to take on this diverse role!

A clinical-stage biotech company is seeking an Associate Director, Clinical Operations Compliance to play a key role within Clinical Operations, providing compliance support for sponsored clinical trials. This position focuses on ensuring alignment with the company’s Standard Operating Procedures (SOPs), applicable regulatory requirements (FDA, EU, ICH, and country-specific), and current industry standards and practices.

Key Responsibilities:

• Support the development, revision, and maintenance of SOPs, processes, and procedures to ensure compliance with applicable GCP standards and guidelines, promoting inspection readiness.
• Identify risks in clinical study processes and provide recommendations for mitigation.
• Act as the SME for Clinical Operations personnel regarding GCP, SOPs, non-compliance surveillance, Quality Events, audit/inspection responses, and process optimization.
• Collaborate with Clinical Operations and QA to remediate quality issues and implement continuous improvement initiatives.
• Conduct quality reviews of clinical trial documents, focusing on compliance, regulatory requirements, and risk management.
• Support inspection readiness activities, such as Trial Master File (TMF) activities and study documentation.
• Provide strategic quality operational guidance to ensure proper planning and execution of clinical trials across assigned programs, covering systems, processes, procedures, training, GCP compliance, and regulatory inspection readiness.
• Contribute to other Clinical Operations Compliance or GCP activities as needed.

Required Skills, Experience, and Education:

• RN or bachelor’s/master’s degree in biological sciences or health-related fields.
• Minimum of 8 years of experience in GCP Quality and/or Clinical Operations within the pharmaceutical or biotech industry. Relevant indirect experience may also meet this requirement.
• Expertise in Quality Assurance, SOP development, inspection readiness, and CAPA preparation/closure.
• Deep understanding of FDA Regulations, ICH Guidelines, and GCP standards related to late-stage or post-marketed products.
• Proven ability to bridge interdisciplinary teams and provide guidance on compliant clinical development operations.
• Strong organizational skills with the ability to multitask, prioritize, and adapt to shifting demands.
• Excellent interpersonal, verbal, and written communication skills, with the ability to engage colleagues and partners at all levels.
• Proficiency in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint, Visio); MS Project and/or Smartsheet is a plus.
• Ability to handle time-sensitive demands, incomplete information, and unexpected events.
• Willingness to travel (~25%).

Preferred Skills:

• Familiarity with vendor systems/portals (e.g., eTMF, EDC, IRT, CTMS).
• Oncology experience, particularly in early and/or late-stage trials, is strongly preferred.
• Knowledge of Ex-US clinical trial operations is a plus.

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