Associate Director, Clinical Operations Compliance and Training

Associate Director, Clinical Operations Compliance and Training in Redwood City, California Overview 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. Bayside Solutions, Inc. may collect your personal information during the position application process. Please reference Bayside Solutions, Inc.'s