Associate Director, Clinical Operations Compliance & Training
- Full-time
Job Description
Associate Director, Clinical Operations Compliance & Training
W2 Contract-to-Hire
Salary Range : $208,000 - $239,200 per year
Location : Redwood City, CA - Hybrid Role
Job Summary :
This is a unique opportunity for a Clinical Operations Compliance Professional. As a Sr. Clinical Program Manager (Sr. CPM), you will be in a key role in the Clinical Operations, Compliance, and Training function in Clinical Operations to support the development and continuous improvement of GCP infrastructure using knowledge and experience with clinical study management, International Conference on Harmonization (ICH) Guidelines, Good Clinical Practices (GCP), and regulatory requirements.
Duties and Responsibilities :
- Support Clinical Operations with GCP guidance and best industry practices.
- Contribute to the management of business and compliance metrics to assess and continuously improve oversight and inspection readiness throughout the clinical trial lifecycle.
- Support Clinical Operations Inspection Readiness activities.
- Contribute to Clinical Operations training programs to deliver the company standards, GCP, and regulatory requirements.
- Partner cross-functionally and with QA on remediation plans and continuous improvement of GCP systems, as well as audit responses.
- Communicate deliverable status / issues, and problem-solve to ensure functional goals are met.
- Use all available tools to track, oversee, and communicate on project status to all key stakeholders.
- Participate in other Clinical Operations Compliance & Training activities as assigned.
Requirements and Qualifications :
Preferred Qualifications :
Desired Skills and Experience
Clinical Operations Compliance, Clinical Operations Training, GCP compliance, Good Clinical Practices, ICH Guidelines, International Conference on Harmonization, FDA regulations, clinical study management, regulatory requirements, compliance metrics, business metrics, inspection readiness, clinical trial lifecycle, audit responses, remediation plans, continuous improvement, GCP systems, quality assurance, cross-functional collaboration, SOP development, SOP authoring, clinical SOPs, oversight activities, monitoring oversight, risk assessment, risk mitigation, project management, stakeholder communication, deliverable tracking, clinical quality assurance, pharmaceutical industry experience, biotech industry experience, clinical research, operational data analysis, Microsoft Office Suite, Outlook, MS Word, Excel, PowerPoint, MS Project, Smartsheet, oncology clinical trials, early stage clinical trials, late stage clinical trials, Ex-US regulations, international regulations, clinical program management, GCP infrastructure, compliance training programs, clinical operations best practices, project status tracking, interdisciplinary team collaboration, written communication, verbal communication, interpersonal skills
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.
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