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Thermo Fisher Scientific logo
Thermo Fisher Scientific

The World Leader In Serving Science

Study Manager – Global Study Management

ManagerManagerFull TimeRemoteSeniorTeam 10,001+Since 1956H1B SponsorCompany SiteLinkedIn

Location

Mexico

Posted

43 days ago

Salary

0

Seniority

Senior

Bachelor Degree3 yrs expEnglishGoogle Cloud Platform

Job Description

Study Manager – Global Study Management

Thermo Fisher Scientific

• Study Manager (SM) is a key member of the Global Study Team contributing to delivering the clinical study to time, cost and quality, and ensuring inspection readiness by taking an oversight over study eTMF completeness. • SM works in close partnership with the Study Delivery Lead (SDL) on end-to-end operational study delivery activities, from study setup to study archival. • SM works cross-functionally, with internal and external partners, on clinical study management activities as agreed with the Study Delivery Lead. • SM is responsible for monitoring study conduct and progress, identifying, resolving and escalating risks/issues which may impact delivery of the study to the necessary quality, timeline and budget objectives. • SM is responsible for facilitating and maintaining interactions and meetings with internal and external partners to ensure the successful delivery of assigned studies. • SM is responsible for data oversight to ensure the study is inspection ready at all times, including oversight of eTMF completeness.

Job Requirements

  • At least 3+ years of relevant work experience in a pharmaceutical/scientific environment.
  • Knowledge of clinical trials, drug development process.
  • Excellent knowledge of ICH-GCP, clinical study delivery process, including regulations, operational best practices, industry standards.
  • Well familiar with key systems used in clinical trial delivery.
  • Experience in using Trial Master File industry accepted standard.
  • Strong project management skills (preferably with analytical / financial skills) and good leadership skills.
  • Excellent verbal and written communication in English.

Benefits

  • Accessible disability services
  • Professional development opportunities

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