Clinical Trial Manager

hace 4 semanas


Madrid, Madrid, España Icon A tiempo completo

Role Summary

As a Clinical Trial Manager at ICON, you will be responsible for coordinating and leading local trial teams to deliver quality data and trial documents/records that are compliant with assigned protocols, codes of Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and regulatory requirements.

The successful candidate will be the primary point of contact at a country level for assigned studies and will be responsible for country do-ability and site feasibility assessment in conjunction with CTA, CRA, and PM.

Key Responsibilities

  • Implement local criteria for site selection
  • Ensure consistent conduct of pre-trial assessment visits and instruct teams on appropriate follow-up of pre-trial visit report and country feasibility report
  • Recommend suitable sites for selection to participate in trial
  • Collaborate with the CPL, PM, local management/Country Head, and Protocol Owner to select final site list
  • Contribute input to the Trial Plan, Safety Monitoring Plan, Filing and Archiving Plan, and Investigational Product documents at a country level or initiate development of these plans for a single country trial
  • Lead and coordinate local trial team activities in compliance with GCO Standard Operating Procedures (SOP), Work Instructions (WI), and applicable regulations
  • Lead local project planning activities to meet recruitment targets and deliver high-quality data on time and within study budget

Requirements

  • A minimum of a BA/BS degree is required
  • A degree in a health or science-related field is preferred
  • Experience as Lead CRA/LTM/CTM of at least 2 years
  • Experience in submissions
  • Specific therapeutic area experience may be required depending on the position
  • Basic understanding of the drug development process, including ICH/GCP, and local regulatory requirements
  • Solid communication and computer skills required
  • Proficient in speaking and writing the country language and English language

What ICON Can Offer

At ICON, diversity, inclusion, and belonging are fundamental to our culture and values. Our rich diversity makes us more innovative, which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organization.

We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.


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