Senior Compliance Specialist (FSP), Remote (US)
RemoteNorth Carolina, United States
Job Summary
Execute quality and compliance strategies and initiatives across the organization to support high-quality clinical research programs. Track, report, and document quality activities while leading processes and process improvement initiatives. Research, investigate, and resolve compliance issues by maintaining metrics, reports, and required documentation. Coordinate with cross-functional teams for client audits, CAPA management, and procedural documentation. Lead smaller projects and serve as a project lead for assigned group initiatives. Mentor team members and represent the department as a primary point of contact for internal and external stakeholders. Apply comprehensive knowledge of ICH GCP and applicable regulations to ensure quality standards are maintained throughout clinical development programs.
Required Qualifications
- Bachelor's degree or equivalent combination of relevant education, training, and experience
- Previous experience that provides the knowledge, skills, and abilities to perform the role (comparable to 4+ years of relevant experience) or an equivalent combination of education, training, and experience
- In some cases, an equivalency consisting of appropriate education, training, and/or directly related experience will be considered sufficient to meet the requirements of the role
- Comprehensive knowledge of ICH GCP and other applicable clinical research regulations and guidelines
- Proven project management experience managing clinical trial delivery activities and cross-functional initiatives
- Extensive knowledge of the clinical trial process
- Excellent oral and written communication skills
- Strong organizational and time-management skills with the ability to manage multiple priorities
- Demonstrated problem-solving and analytical skills
- Excellent attention to detail
- Strong computer skills with the ability to quickly learn new software applications
- Ability to work independently while collaborating effectively within cross-functional teams
- Proven flexibility, adaptability, and sound judgment when managing competing priorities
- Experience mentoring colleagues and leading project or process improvement initiatives
- Occasional travel to client sites or company offices, both domestic and international, may be required
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