Associate Director, Clinical Operations Compliance & Training
The Opportunity
Seeking a Associate Director, Clinical Operations Compliance & Training (contractor), who will play a key role within Clinical Operations and is responsible for providing compliance support for sponsored clinical trials with respect to Standard Operating Procedures, Good Clinical Practice (GCP), applicable regulatory requirements, and current industry standards and practices.- SME for Clinical Operations personnel for issues relating to GCP, best practices, SOPs, non-compliance, etc.
- Support Clinical Operations Inspection Readiness initiatives.
- Support the development, revision, and continuous improvement of Clinical Operations SOPs, Work Instructions/Policies in compliance with GCP, company standards, and regulatory requirements.
- Contribute to the development and execution of Clinical Operations training programs.
- Other assigned Clinical Operations activities, as appropriate.
- RN or bachelor’s or master’s degree in biological sciences or health-related field required.
- 10+ years in GCP Quality Assurance, Clinical Compliance, and/or Clinical Operations experience in the pharmaceutical or biotech industry.
- Strong working knowledge of FDA Regulations, ICH Guidelines, and GCP
- Strong background in Inspection Readiness activities.
- Demonstrated experience developing and authoring Clinical and cross-functional SOPs.
- Outstanding organizational skills with the ability to multi-task and prioritize.
- Excellent interpersonal, verbal, and written communication skills, with 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 upon changing priorities.
- Demonstrated proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint, Visio); MS Project and/or Smartsheet a plus.
- Travel may be required (~25%)
- Oncology experience, early and/or late stage preferred.
- Strong working knowledge of ex-US regulations and requirements
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