Clinical Trial Delivery Lead (Senior Project Manager)

As a Clinical Trial Delivery Lead, 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:

• Provide functional leadership 
• Oversee external providers as applicable
• Accountable for the delivery and quality of Phase I-IV, Epidemiology and Real World Evidence Company Sponsored Studies; Collaborative Research Studies; Investigator Sponsored Studies, Early Access Programs and other research activities as applicable.
• Provide leadership, strategic direction and operational oversight across assigned program(s)/ study(ies)
• Serve as the operational delivery expert for the program(s)/study(ies) and promote data-driven, realistic planning at the site and study level.  Drive delivery-focused accountability and ownership amongst key external (CRO) and internal partners as appropriate
• Facilitate identification and implementation of operational excellence strategies across program(s)/study(ies)
• Identify trends and issues across assigned program(s)/study(ies) which may impact key study deliverables and work with relevant business partners to implement action plans to resolve and/or mitigate
• Drive proactive risk-based site oversight/study management practices and quality risk oversight and management across all stages of study delivery 
• Ensure timely and appropriate escalation of trends, issues and risks as appropriate
• Promote product knowledge, collaboration and information channeling; contribute to best practice guidance to drive consistency in the management of sites/studies
• Being single point of contact for operational topics and escalations, support information channeling and facilitating solutions at the program level
• Participate in Investigator/Study Coordinator Meetings and promote information sharing as needed
• Act as functional lead for process improvement initiatives
• Other accountabilities as assigned by Functional Manager in support of the business

You are:

• Clinical operations professional with experience ideally across Phases (I-IV)
• Expert knowledge of clinical development (principles and concepts as well as regulatory environment e.g. ICH GCP and applicable regional/local regulations)
• You are a Global Clinical Trial Manager with experience in Recruitment Strategy and DCT.
• Substantial (10+ years) professional and project management experience in clinical research in a CRO, pharma or biotech company including site management/oversight, clinical study planning and conduct
• Oncology and/or Neurology and/or Immunology TA experience desired 

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.