Senior Clinical Compliance Specialist – FSP
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Job Description
Clinical Compliance Specialist managing quality and compliance in clinical trials at Thermo Fisher Scientific. Responsible for tracking compliance to ICH GCP requirements in ongoing clinical operations.
Responsibilities:
- 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
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
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