Senior Manager, Clinical Compliance

Summary

Join Dynavax, a biopharmaceutical company, as a Senior Manager, Clinical Compliance, working remotely from anywhere in the United States. You will oversee clinical trial and compliance activities, ensuring adherence to GCP, regulations, and SOPs. Responsibilities include supporting investigations, conducting root cause analyses, advising on audits, coordinating document submissions, developing SOPs, and identifying process improvement opportunities. You will partner with the GCP/PVG Quality & Compliance Department and collaborate with internal and external teams. Occasional travel may be required. This contract position offers a flexible work environment and competitive hourly pay.

Requirements

• BA/BS in Life Sciences or equivalent
• 7+ years clinical research and clinical project management related experience
• 1+ year of clinical operations compliance experience
• Expert knowledge of ICH-GCP and FDA regulations
• Strong knowledge of protocol and clinical drug development processes, clinical study design, study planning and site management/monitoring
• Extensive experience with effective root cause investigation, corrective and preventive action planning, execution and verification of effectiveness techniques
• Ability to perform detail-oriented work on multiple projects with a high degree of accuracy under minimal supervision and aggressive timelines
• Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, etc.), Adobe and eTMF systems
• Robust organizational, documentation and interpersonal skills as well as a willingness to work within a team-oriented environment
• Ability to sit; stand; walk; reach with arms and hands; lift and move small objects; and use hands to keyboard and perform other office related tasks including repetitive movement of the wrists, hands and/or fingers

Responsibilities

• Support investigations, effectiveness checks and assist with managing Clinical Quality Events (non-conformances, deviations, quality issue trends)
• Help conduct root cause analysis
• Advise on preparation for audits and coordination and completion of corrective actions from audits and inspections of clinical studies
• Coordinate document/form completion, revisions and submissions to GCP/PVG Quality & Compliance Department and facilitate document drafting and review to applicable Clinical Operations team members
• Develop and/or maintain Clinical SOPs including revisions and periodic (biennial) reviews
• Respond to common clinical process inquiries from internal and external team members
• Proactively identify gaps, inform of potential problems or opportunities to improve the Clinical processes and work to implement process improvement, address and resolve issues and gaps; escalate as appropriate
• Partner with the GCP/PVG Quality & Compliance Department; act as lead Clinical Operations contact when applicable
• May work with CRAs on monitoring oversight and perform oversight visits
• Support Clinical Project Managers with oversight of study CROs and other external vendors to facilitate their ability to complete trials within timelines and quality as required. This includes training key external staff on trial requirements throughout the trial duration
• Develop productive working relationships with internal colleagues, investigational site staff and CRO/vendor personnel to ensure high quality reporting and compliant study execution
• Occasional travel may be required, up to 25%
• Other duties as assigned

Preferred Qualifications

Master’s degree

Benefits

• 100% remote work (US based)
• $125 - $125 an hour