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ICON plc logo
ICON plc

ICON plc, or simply ICON, is a global provider of outsourced development services to companies in industries like biotechnology, medical devices, and pharmaceut

Senior Clinical Trial Manager

Location

Pennsylvania

Posted

62 days ago

Salary

0

Seniority

Senior

Bachelor Degree3 yrs expEnglishGoogle Cloud Platform

Job Description

Senior Clinical Trial Manager

ICON plc

• Accountable for ensuring top-quality end-to-end trial delivery at a country level. • Managing the consistency of Local Trial Management duties and processes. • Serving as the country-level single point of contact on the study for internal partners. • Managing and overseeing Central IRB and other local vendors including set up of vendor purchase orders, invoice review and approval, and change-orders. • Execution of local milestones from feasibility through study close out. • Resourcing of country-level roles, including support with transitions. • Inspection Readiness and AQR at the country level. • Close collaboration with assigned Local Trial Managers, Lead Site Manager, Site Managers, Clinical Trial Associates, and Site Contract Managers. • Efficient communication with Clinical Trial Managers and Global Trial Leader to oversee trial excellence. • Conducting country level ad hoc meetings during any phase of the study to address unexpected circumstances.

Job Requirements

  • BA/BS degree
  • Degree in a health or science related field
  • 3 - 5+ years of trial end to end management experience
  • Start-up & Database Locks/Cleaning experience preferred
  • Oncology Solid Tumor experience required
  • Specific therapeutic area experience may be required depending on the position.
  • Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures.
  • Strong IT skills in appropriate software and company systems.
  • Willingness to travel with occasional overnight stay away from home according to business needs.
  • Proficient in speaking and writing the country language and English.
  • Good written and oral communication skills as appropriate

Benefits

  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family’s needs.
  • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
  • Life assurance
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

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