Associate Director, Clinical Operations Compliance & Training

2 Days Old

Associate Director, Clinical Operations Compliance & Training Join to apply for the Associate Director, Clinical Operations Compliance & Training role at Planet Pharma Associate Director, Clinical Operations Compliance & Training 5 days ago Be among the first 25 applicants Join to apply for the Associate Director, Clinical Operations Compliance & Training role at Planet Pharma Get AI-powered advice on this job and more exclusive features. 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.
Job Description
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.
Required Skills, Experience And Education
RN or bachelors or masters 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
The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Seniority level Seniority level Not Applicable Employment type Employment type Full-time Job function Job function Research, Analyst, and Information Technology Industries Staffing and Recruiting Referrals increase your chances of interviewing at Planet Pharma by 2x Sign in to set job alerts for Associate Director Clinical Operations roles. South San Francisco, CA $150,000.00-$190,000.00 5 days ago Associate Director/Director, Clinical Operations, Autoimmune South San Francisco, CA $180,000.00-$240,000.00 10 months ago Associate Director, Clinical Operations - Oncology (Compound Lead) South San Francisco, CA $191,000.00-$212,000.00 3 weeks ago South San Francisco, CA $126,000.00-$160,000.00 3 weeks ago Clinical Trial Manager/Senior Clinical Trial Manager Millbrae, CA $130,000.00-$142,500.00 1 week ago Sunnyvale, CA $103,000.00-$174,400.00 2 weeks ago Millbrae, CA $165,000.00-$180,500.00 1 week ago Join our Talent Community- Clinical Trial Manager Redwood City, CA $165,000.00-$200,000.00 5 days ago Sr. Mgr, Inspection Readiness, Business Operations, Clinical Operations (Remote Or Office) Brisbane, CA $165,000.00-$200,000.00 2 weeks ago Sr. Clinical Trial Manager, Supira Medical Sr. Mgr, Inspection Readiness, Business Operations, Clinical Operations (Remote Or Office) Hayward, CA $165,000.00-$200,000.00 2 weeks ago Senior Clinical Trial Manager (Contractor) Alameda, CA $98,000.00-$196,000.00 21 hours ago Senior Clinical Trial Manager, Supira Medical Sunnyvale, CA $125,500.00-$212,400.00 2 weeks ago San Francisco Bay Area $180,000.00-$225,000.00 2 weeks ago Sunnyvale, CA $103,000.00-$174,400.00 2 weeks ago Associate Director, Process Development and Documentation, Clinical Quality Assurance Redwood City, CA $183,300.00-$215,600.00 1 week ago Fremont, CA $105,000.00-$195,000.00 3 months ago Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr
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Location:
Redwood City, CA, United States
Job Type:
FullTime
Category:
Management Occupations

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