Project Manager, GCP Oversight

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

• What you will be doing:
  
  

  • Responsible for planning and executing systematic and independent assessments of clinical trial processes through documentation and deliverable review and study team engagement
  • Contributing member of an independent team focused on clinical trial delivery quality assessment for ongoing operations and processes within supported functional areas
  • Performs proactive as well as routine evaluation of clinical trial processes to determine adherence to process and procedural documentation through documentation review and active engagement with study team functional representatives
  • Helps develop and maintain KPIs, metrics and dashboards to track process quality and compliance
  • Provides near real-time feedback on study process and documentation quality as well as team performance and understanding on evaluated processes.
  • Ensure compliance with own Learning Curricula, corporate and/or GXP requirements.
  • Represent GCP Compliance in meetings as needed.

You are:

• Domestic/international travel (5-20%) may be required
• Minimum of 4+ years clinical research experience in pharmaceutical or biotechnology field
• Solid knowledge of drug development, clinical trial management and/or GCP compliance processes
• Proven track record of strong project management skills and experience managing clinical trial delivery activities for drug development programs.
• Experience in problem solving, negotiations and collaborative team building with non- direct reports and other stakeholders is required
• Solid knowledge of regulatory requirements governing clinical trial, industry best practices and related standard and documentation requirements
• BS, MS or equivalent in scientific field
• Must be able to efficiently utilize computer software programs such as Microsoft Office for general use, project management and presentations
• Effectively resolve conflict in a constructive manner

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise 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

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, diversity, inclusion & 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 organisation. 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. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

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