Thermo Fisher Scientific logo
Thermo Fisher Scientific

The World Leader In Serving Science

Senior Clinical Compliance Specialist – FSP

ComplianceComplianceFull TimeRemoteSeniorTeam 10,001+Since 1956H1B SponsorCompany SiteLinkedIn

Location

North Carolina

Posted

26 days ago

Salary

Not specified

Seniority

Senior

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

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