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Thermo Fisher Scientific logo
Thermo Fisher Scientific

The World Leader In Serving Science

Global Study Manager – FSP

ManagerManagerFull TimeRemoteSeniorTeam 10,001+Since 1956H1B SponsorCompany SiteLinkedIn

Location

Bulgaria

Posted

113 days ago

Salary

0

Seniority

Senior

Bachelor Degree5 yrs expEnglishGCP

Job Description

Global Study Manager – FSP

Thermo Fisher Scientific

• Accountable for the operational delivery of clinical study/studies to time, quality, and budget • Supporting decision-making at pace and leading study team to achieve overall study deliverables • Proactively and effectively identifies, oversees, and mitigates study risks • Ensures appropriate stakeholder communication, including study status, expectations, risks and issues • Responsible for operational input into protocol and informed consent form development • Leads and conducts investigator meetings and other study related meetings • Leads quality efforts to ensure protocol compliance and continual inspection readiness for assigned studies

Job Requirements

  • Bachelor’s degree: life sciences or related discipline
  • At least 5+ years of relevant study management experience on a global level
  • In-depth experience in clinical research: study management, monitoring, data management
  • Must have exposed to clinical study management “end-to-end”
  • Must have at least Ph II and PIII experience
  • Strong experience in clinical budget management
  • Strong experience with vendor management including CRO
  • Fluent in English, to the level they can negotiate and discuss related to complex topics
  • Excellent stakeholder management and communication skills
  • Strong understanding of the clinical study, drug development, sample management and other associated process and quality requirements, including ICH/GCP guidelines and SOPs
  • Good project management skills.

Benefits

  • Health insurance
  • Flexible work arrangements
  • Professional development opportunities

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