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Thermo Fisher Scientific logo
Thermo Fisher Scientific

The World Leader In Serving Science

Clinical Team Manager – Senior, FSP

ManagerManagerFull TimeRemoteSeniorTeam 10,001+Since 1956H1B SponsorCompany SiteLinkedIn

Location

North Carolina

Posted

37 days ago

Salary

0

Seniority

Senior

Bachelor Degree5 yrs expEnglishGoogle Cloud Platform

Job Description

Clinical Team Manager – Senior, FSP

Thermo Fisher Scientific

• Accountable for achieving the final clinical deliverable (usually clean data from evaluable patients as specified in the study protocol) within the time period specified in the contract with the customer • Interprets data on complex issues and makes good business decisions with support from line management • Works to ensure that all clinical deliverables meet the customer's time/quality/cost expectations • Manages all aspects of monitoring operations and quality for assigned studies, ensuring compliance with ICH GCP and applicable local regulations • Develops clinical tools and study plans, collaborates with client (to include but not limited to CCSLs) and leads team meetings to maintain timelines, resources, and quality • Serves as clinical subject matter expert for protocol and point of escalation for site manager as applicable • Ensures timely deliverables, monitors trials, communicates with study sites, coordinates start-up activities, addresses regulatory requirements and provides input on forecast estimates and resource management • Completes trip report reviews in compliance with study plan timeline • Issue escalation per plan, responsible for identifying and reporting site performance issues, trend analysis

Job Requirements

  • Bachelor's degree
  • previous experience comparable to 5+ years
  • Monitoring, Study Management or Oversight experience preferred
  • Prior client-dedicated experience preferred
  • Advanced mentoring/leadership/supervisory skills
  • Excellent clinical trials monitoring skills; ideally remote AND onsite experience
  • Demonstrated understanding of or ability to learn the company’s SOPs, WPDs, and relevant regulations (e.g. ICH/GCP, FDA guidelines)
  • Strong organizational and negotiation skills
  • Strong attention to detail
  • Advanced written and oral communication skills
  • Strong knowledge of English language and grammar
  • Demonstrated use of computer to include data entry, archival and retrieval
  • Excellent team player with team building skills
  • Excellent interpersonal and conflict resolution skills
  • Advanced ability to utilize problem-solving techniques applicable to constantly changing environment
  • Solid knowledge of medical/therapeutic areas and medical terminology

Benefits

  • competitive remuneration
  • annual incentive plan bonus
  • healthcare
  • a range of employee benefits

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