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Associate Director, Clinical Operations Compliance & Training
Job Description
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.
Required Skills, Experience and Education:
- 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%)
Preferred Skills:
- Oncology experience, early and/or late stage preferred.
- Strong working knowledge of ex-US regulations and requirements
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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