Bayside Solutions
Associate Director, Clinical Operations Compliance & Training
Bayside Solutions - California, Missouri, United States, 65018
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Overview
Associate Director, Clinical Operations Compliance & Training
Associate Director, Clinical Operations Compliance & Training
1 day ago Be among the first 25 applicants This range is provided by Bayside Solutions. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range
$85.00/hr - $95.00/hr Associate Director, Clinical Operations Compliance & Training W2 Contract-to-Hire Salary Range:
$176,800 - $197,600 per year Location:
Redwood City, CA - Onsite Role Job Summary: We are seeking a Temporary Associate Director, Clinical Operations Compliance & Training, who will play a key role within Clinical Operations and is responsible for providing compliance support for the sponsored clinical trials with respect to the standard Operating Procedures, Good Clinical Practice (GCP), applicable regulatory requirements, and current industry standards and practices. Duties and Responsibilities: 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 and regulatory requirements. Contribute to the development and execution of Clinical Operations training programs. Other assigned Clinical Operations activities, as appropriate. Requirements and Qualifications: RN or bachelor's or master's degree in biological sciences or a 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 multitask and prioritize. Excellent interpersonal, verbal, and written communication skills, with the 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 on 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 Qualifications: Oncology experience, early and/or late stage preferred. Strong working knowledge of ex-US regulations and requirements Desired Skills and Experience Clinical Operations Compliance, Clinical Operations Training, Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), FDA Regulations, ICH Guidelines, Regulatory Compliance, Inspection Readiness, Quality Assurance, Clinical Trials Management, SOP Development, SOP Authoring, Work Instructions Development, Clinical Operations Best Practices, Training Program Development, Pharmaceutical Industry Experience, Biotech Industry Experience, GCP Compliance, Regulatory Requirements, Cross-functional SOPs, Clinical Compliance, Microsoft Office Suite, MS Word, Excel, PowerPoint, Visio, MS Project, Smartsheet, Organizational Skills, Multitasking, Priority Management, Written Communication, Verbal Communication, Interpersonal Skills, Oncology Clinical Trials, Early Stage Clinical Trials, Late Stage Clinical Trials, Ex-US Regulations, International Regulatory Requirements, Healthcare Compliance, Clinical Research, Process Improvement, Continuous Improvement, Policy Development, Stakeholder Management, Team Collaboration 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 CCPA Privacy Policy at www.baysidesolutions.com. Seniority level
Seniority level Not Applicable Employment type
Employment type Contract Job function
Job function Research and Science Referrals increase your chances of interviewing at Bayside Solutions by 2x Sign in to set job alerts for “Associate Director Clinical Operations” roles.
Associate Director/Director, Clinical Operations, Autoimmune
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Associate Director, Clinical Operations Compliance & Training
San Mateo County, CA $85.00-$95.00 1 week ago Associate Director, Clinical Operations Compliance & Training
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Associate Director, Clinical Operations Compliance & Training
1 day ago Be among the first 25 applicants This range is provided by Bayside Solutions. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range
$85.00/hr - $95.00/hr Associate Director, Clinical Operations Compliance & Training W2 Contract-to-Hire Salary Range:
$176,800 - $197,600 per year Location:
Redwood City, CA - Onsite Role Job Summary: We are seeking a Temporary Associate Director, Clinical Operations Compliance & Training, who will play a key role within Clinical Operations and is responsible for providing compliance support for the sponsored clinical trials with respect to the standard Operating Procedures, Good Clinical Practice (GCP), applicable regulatory requirements, and current industry standards and practices. Duties and Responsibilities: 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 and regulatory requirements. Contribute to the development and execution of Clinical Operations training programs. Other assigned Clinical Operations activities, as appropriate. Requirements and Qualifications: RN or bachelor's or master's degree in biological sciences or a 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 multitask and prioritize. Excellent interpersonal, verbal, and written communication skills, with the 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 on 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 Qualifications: Oncology experience, early and/or late stage preferred. Strong working knowledge of ex-US regulations and requirements Desired Skills and Experience Clinical Operations Compliance, Clinical Operations Training, Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), FDA Regulations, ICH Guidelines, Regulatory Compliance, Inspection Readiness, Quality Assurance, Clinical Trials Management, SOP Development, SOP Authoring, Work Instructions Development, Clinical Operations Best Practices, Training Program Development, Pharmaceutical Industry Experience, Biotech Industry Experience, GCP Compliance, Regulatory Requirements, Cross-functional SOPs, Clinical Compliance, Microsoft Office Suite, MS Word, Excel, PowerPoint, Visio, MS Project, Smartsheet, Organizational Skills, Multitasking, Priority Management, Written Communication, Verbal Communication, Interpersonal Skills, Oncology Clinical Trials, Early Stage Clinical Trials, Late Stage Clinical Trials, Ex-US Regulations, International Regulatory Requirements, Healthcare Compliance, Clinical Research, Process Improvement, Continuous Improvement, Policy Development, Stakeholder Management, Team Collaboration 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 CCPA Privacy Policy at www.baysidesolutions.com. Seniority level
Seniority level Not Applicable Employment type
Employment type Contract Job function
Job function Research and Science Referrals increase your chances of interviewing at Bayside Solutions by 2x Sign in to set job alerts for “Associate Director Clinical Operations” roles.
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 Millbrae, CA $130,000.00-$142,500.00 1 week ago San Mateo County, CA $80.00-$90.00 2 days ago Redwood City, CA $165,000.00-$200,000.00 1 week ago Millbrae, CA $165,000.00-$180,500.00 1 week ago Sr. Mgr, Inspection Readiness, Business Operations, Clinical Operations (Remote Or Office)
Brisbane, CA $165,000.00-$200,000.00 1 day ago Associate Director, Process Development and Documentation, Clinical Quality Assurance
Redwood City, CA $183,300.00-$215,600.00 2 weeks ago East Palo Alto, CA $66,560.00-$83,200.00 2 weeks ago Associate Director of Data and Knowledge Management
Associate Director, Clinical Operations Compliance & Training
San Mateo County, CA $85.00-$95.00 1 week ago Associate Director, Clinical Operations Compliance & Training
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr