ICON

Manager, Externally Sponsored Research

US, Blue Bell (ICON) Full time
Manager, Externally Sponsored Research

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

Responsibilities:

  • Acts as the primary local operational contact for all external and internal stakeholders for assigned studies

  • Provides guidance to external and internal stakeholders on ESR operational processes

  • Facilitates local governance meetings including meeting minute documentation, reviews proposals for completeness

  • Manages operational compliance with global and local policies, processes, and procedures within assigned tumor type area(s) to ensure timely, cost efficient and high-quality project delivery

  • Monitors performance routinely and escalating to obtain necessary approvals for milestones shifts or deviations

  • Coordinates effective collaboration and communications between internal stakeholders and external partners to enable high quality research projects

  • Routinely reviews assigned study performance and escalates when projects are not being managed to time, cost and quality

  • For studies that are not on track, ensures corrective action plans are created and documented in ESR study management system and action plans are progressing as planned

  • Addresses as a matter of urgency any compliance issues, escalating problems as appropriate

  • Ensure timely preparation of research CDAs/CSAs

  • Serves as liaison between sponsor site and contracting team

  • Management, with a proven track record of leading successful trials.

  • Strong understanding of regulatory requirements and GCP in clinical research.

  • Excellent leadership and communication skills, with the ability to motivate and manage cross-functional teams.

  • Proven analytical and problem-solving skills, capable of navigating complex project challenges.

Your Profile:

  • Bachelor’s degree within a scientific or healthcare field or significant and comparable experience

  • Experience within the pharmaceutical industry ideally working within a clinical study management and/or Externally Sponsored Research related role

  • Experience working in study management systems

  • Experience and knowledge of the clinical study and drug development processes and relevant guidelines, e.g., GCP/ICH for a specific therapeutic and geographical area

  • 6-month assignment with potential to renew

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 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.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values.   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 or submit a request here.

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.

Are you a current ICON Employee? Please click here to apply