Thermo Fisher Scientific logo
Thermo Fisher Scientific

The World Leader In Serving Science

Central Review Manager, Senior

ManagerManagerFull TimeRemoteSeniorTeam 10,001+Since 1956H1B SponsorCompany SiteLinkedIn

Location

Bulgaria

Posted

3 days ago

Salary

0

Seniority

Senior

Bachelor Degree2 yrs expExperience acceptedEnglish

Job Description

Central Review Manager, Senior

Thermo Fisher Scientific

• Performs review of clinical monitoring visit reports for allocated projects ensuring consistency across protocols and/or regions • Liaises with clinical monitoring staff for prompt trip report review submission and approval as per the stipulated timelines of PPD and/or the Sponsor • Reviews and customizes the Monitoring Report Templates for allocated projects • Evaluates PI oversight, subject safety and study processes to assess site’s ability to conduct study • Attends applicable internal Project meetings • Provides input of forecast estimates for report review activities • Provides trial MVR status tracking and progress update reports to CTM/CRA • Contributes to company, client, and federal/local regulatory requirements/audit responses • Provides training and mentoring to new CRMs • May act as lead report reviewer on allocated projects

Job Requirements

  • Bachelor’s Degree in a science-related field or relevant/equivalent combination of education, training, and experience
  • Prior clinical research experience with a minimum of 2 years on site clinical monitoring
  • Excellent therapeutic area knowledge and understanding of medical terminology
  • Ability to attain and maintain a working knowledge of FDA and/or local country regulation and guidelines, ICH GCPs and PPD procedural documents
  • Highly effective oral and written communication skills
  • Excellent organizational and time management skills
  • Ability to write clinical monitoring visit reports, review or approve them and interpret the information captured in clinical monitoring visit reports
  • Ability to mentor junior team members

Benefits

  • Health insurance
  • 401(k)
  • Flexible work arrangements
  • Professional development
  • Paid time off

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