Thermo Fisher Scientific
The World Leader In Serving Science
Senior Clinical Compliance Specialist – FSP
Location
North Carolina
Posted
16 days ago
Salary
Not specified
Bachelor Degree4 yrs expExperience acceptedEnglishGoogle Cloud Platform
Job Description
• Executes quality and compliance processes across the organization and facilitates the tracking and reporting of quality and compliance activities
• Responsible for planning, monitoring, and reporting on quality and compliance for selected clinical trial delivery processes to determine adherence and understanding of ICH GCP requirements and processes
• Contributing member of an independent team focused on clinical trial delivery quality assessment for ongoing operations and processes within supported functional areas
• Performs proactive as well as routine evaluation of clinical trial processes to determine adherence to process and procedural documentation through documentation review and active engagement with study team functional representatives
• Helps develop and maintain KPIs, metrics and dashboards to track process quality and compliance
• Provides near real-time feedback on study process and documentation quality as well as team performance and understanding on evaluated processes
• Ensure compliance with own Learning Curricula, corporate and/or GXP requirements
• Represent GCP Compliance in meetings as needed
• Performs other duties as assigned
Job Requirements
- Bachelor’s degree and minimum of 4+ years clinical research experience in pharmaceutical or biotechnology field
- Solid knowledge of drug development, clinical trial management and/or GCP compliance processes
- Proven track record of strong project management skills and experience managing clinical trial delivery activities for drug development programs
- Experience in problem solving, negotiations and collaborative team building with non- direct reports and other stakeholders is required
- Solid knowledge of regulatory requirements governing clinical trial, industry best practices and related standard and documentation requirements
- Must be able to efficiently utilize computer software programs such as Microsoft Office for general use, project management and presentations
- Effectively resolve conflict in a constructive manner
Benefits
- Health insurance
- 401(k) matching
- Flexible work hours