Global Clinical Study Start Up Lead

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.

s a Clinical Study Start Up Lead - Senior Manager, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

You will be working alongside a world-leading pharmaceutical company. This 19- year partnership is focused on leveraging cutting-edge science to make a positive impact in the therapeutic areas of cancer, cardio-metabolic, vaccines, and oncology, which makes up 70% of their portfolio. If you’re looking to make difference, this could be the career destination for you.

What you will be doing:

The role holder will focus on one start-up area of responsibilities for periods of time and/or be working across the startup activities.

• Feasibility and Site Activation Strategy

• Informed Consent Management

• Clinical Site Agreements (CSA)

• General Responsibilities:

  • Contribute to best practices guidance or operational excellence activities to improve the overall performance of Phase I-IV studies.
  • Identify and share lessons learned across GDO department and other R&D functions and ensure implementation of lessons learned across portfolio.
  • Support onboarding of GDO team members and contributing to building of study management capabilities/skills enhancement.
  • Provide expertise in clinical research and keeping up to date with current practices in site start-up activities, innovations & technologies and regulatory changes.
  • Accelerate study start-up and site activation across sponsors portfolio, through process redesign and technologies and innovations enablement, that will speed up product development and bring medicines to patients faster.
  • Design optimal country and site start-up strategies at program/study level, that will attain optimal recruitment rate and maximize our return on investment in R&D.

You are:

• Medical or Life Sciences degree or equivalent qualification.  PM certification (CPM, PMP) desirable.
• At least 10 years in clinical research in a CRO or Pharmaceutical/Biotechnology Industry environment
• Understanding of the overall clinical development paradigm, especially in the area of clinical study operations and have global or regional experience.
• Has 3-5 years of project management and experience in study start-up activities, preferred.
• Experience in oversight of external service providers
• Experience in multiple Therapeutic Areas, especially in oncology and immuno-oncology.
• Thorough knowledge of ICH-GCP and applicable laws and regulations for key countries

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Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, 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.

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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