Senior Compliance Specialist (FSP), Remote (US)
RemoteUnited States or North Carolina, United States
Job Summary
Lead quality and compliance processes to execute strategies across clinical research programs, ensuring activities meet established timelines and standards. Research, investigate, and resolve quality issues while tracking metrics, maintaining reports, and managing required documentation. Coordinate with cross-functional teams for client audits, CAPA management, and procedural documentation. Lead smaller projects and process improvement initiatives to enhance operational effectiveness. Maintain compliance tracking tools and identify trends for continuous improvement. Mentor team members and serve as a primary point of contact on assigned projects, collaborating with internal and external stakeholders. Apply comprehensive knowledge of ICH GCP and applicable regulations to support clinical development programs and ensure quality standards are maintained.
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)
- 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
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.