Associate Director, Clinical Operations Compliance and Training

W2 Contract-to-Hire

Pay Rate: $90 - $110 per hour

Location: Redwood City, CA - Remote Role

Duties and Responsibilities:

• Lead or support the development and implementation of GCP systems and inspection readiness.
• Lead or support the development and continuous improvement of Clinical Policies/ SOPs/ WIs/ Templates/etc. using knowledge and experience with clinical study management, International Conference on Harmonization (ICH) Guidelines, Good Clinical Practices (GCP), and regulatory requirements.
• SME for Clinical Operations GCP guidance, best industry practices, and SOPs.
• Contribute to the development and management of business and compliance metrics to assess and continuously improve the oversight and inspection readiness throughout the clinical trial lifecycle.
• Support Clinical Operations Inspection Readiness activities with clinical study teams; key participation in Mock/Regulatory Authority inspections.
• Contribute to the development and execution of Clinical Operations training programs to deliver the company standards, GCP, and regulatory requirements.
• Partner cross-functionally and with QA on quality initiatives, continuous improvement of GCP systems, and internal audits, and support audit responses.
• Line management responsibilities include hiring, performance management, career development, and mentorship.
• Participate in other Clinical Operations Activities per the business need.

Requirements and Qualifications:

• A bachelor's degree in biological sciences or a health-related field is required.
• 10+ years of direct Clinical Compliance and/or Clinical Quality Assurance experience in the pharmaceutical or biotech industry. Relevant Clinical Operations experiences may also meet the requirement.
• Strong working knowledge of FDA Regulations, ICH Guidelines, and GCP.
• Demonstrated experience successfully developing and authoring Clinical and cross-functional SOPs, ensuring compliance with GCP and regulatory requirements.
• Experience with the development and monitoring of oversight activities.
• Knowledge and/or familiarity with Ex-US region(s), e.g., EMA, MHRA, PDMA.
• Ability to perform complex assessments & investigations, draw relevant conclusions, and implement appropriate solutions.
• Strong analytical, negotiation, and persuasion skills.
• Ability to deal with time demands, incomplete information, or unexpected events.
• Outstanding organizational skills with the ability to multitask and prioritize.
• Excellent interpersonal, verbal, and written communication skills.
• Decision-making skills.
• Comfortable in a fast-paced company environment and able to adjust workload based on changing priorities.
• Demonstrate proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint); MS Project and/or Smartsheet a plus.
• Travel may be required (~25%).

Preferred Qualifications:

• Line Management experience.
• Oncology experience, early and/or late stage, strongly preferred.
• RN or Master's degree in biological sciences or a health-related field preferred.
• Strong working knowledge of ex-US regulations and requirements.

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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