Project Manager Investigator-led studies

Project Manager Investigator-led studies /Homebased UK We are looking for a Project Manager with both clinical research industry and clinical trial management experience to join a dedicated investigator-led trials division. To succeed, you will be an accomplished clinical trial manager with industry experience, multi-country study oversight and the ability to work with Investigators/KOLs on investigator-sponsored study requests. The role

• Planning and management of clinical studies conducted by global development team through the leadership of the cross-functional clinical study team
• Contributing to study-level risk assessments
• Leading and continually review risk mitigation activities to ensure study delivery to plan
• Identifying and resolving issues at a global level
• Collaborating with Regional Clinical Trial Manager to ensure country level study delivery aligned with global delivery plans
• Overseeing global insourcing/outsourcing partner deliverables to the required standards
• Managing study-level budget and timelines
• Leading global study-level documentation and required tool and systems set-up
• Leading development and implementation of global Drug Supply Plan

Main Responsibilities

• Track receipt of investigator-initiated concepts / proposals and early access requests
• Facilitate communication between Sponsor via collaboration with key therapeutic area/medical staff and complete sponsor qualification process (and collaborate as needed)
• Provide protocol submission package (or open case package for early access) including product specific safety information, details of investigator-sponsored studies (or early access) process and requirements to sponsor for protocol review and start-up activities
• Partner with Global Clinical Pricing on budget negotiations and ensure conduct of Fair Market Value assessment

What Is Required

• BA / BS/ BSc in the sciences or RN is required and preferred
• Experience in oversight of external vendors (CROs, central labs, imaging vendors, etc.)
• Strong investigator-sponsored study experience gained within the industry at a clinical trial manager level.
• Influential and effective communication skills
• Previous experience gained in a biotech, pharmaceutical or CRO company is preferred
• Valid and current UK working eligibility

What Is Offered

• The opportunity to work with a sought-after company
• Structured training and on-boarding
• Permanent contract of employment with us 100% seconded to the client
• Flexibility to work fully home-based

Why Join? ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well. 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. At 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. 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. :