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.
We are currently seeking a Study Manager (CTM) to join our diverse and dynamic team. As a SDM at ICON, you will play a pivotal role in supporting the coordination and management of clinical trials, contributing to the design, analysis, and advancement of innovative treatments and therapies.
What you will be doing
- Study Manager (SM) is a key member of the Global Study Team contributing to delivering the clinical study to time, cost and quality, and ensuring inspection readiness by taking an oversight over study eTMF completeness.
- SM works in close partnership with the Study Delivery Lead (SDL) on end-to-end operational study delivery activities, from study setup to study archival, with the focus on setting up, maintaining and ensuring completeness of internal systems / databases / tracking tools and project plans (CSAP).
- SM works cross-functionally, with internal and external partners, on clinical study management activities, as agreed with the Study Delivery Lead, for in-house and outsourced studies across all phases and therapeutic areas, in accordance with Study Team Operating Model (STOM), current clinical study regulations and GSK procedures, policies, best practices and standards, and plays a key role in successful study delivery, providing subject matter expertise across key processes and systems throughout the life cycle of the study.
- SM is responsible for monitoring study conduct and progress, identifying, resolving and escalating risks/issues which may impact delivery of the study to the necessary quality, timeline and budget objectives.
- SM is responsible for reviewing key clinical documents, including the Protocol and Informed Consent Forms, and leading development of study plans (e.g. Monitoring Plan, Vendor Management Plan, Protocol Deviation Management Plan, Risk Management Plan, Communication Plan etc.) for external and internal use in assigned studies.
- SM is responsible for facilitating and maintaining interactions and meetings with internal (including but not limited to regulatory, LOC, quality assurance, Monitors meeting) and external partners (including CROs and third-party vendors) to ensure the successful delivery of assigned studies.
- SM is responsible for vendor management and CRO oversight, acting as a primary point of contact, overseeing study-specific deliverables, ensuring continued monitoring and timely delivery of activities delegated to third parties.
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.
Your profile
- Bachelor's degree in a scientific or related field; advanced degree preferred.
- Minimum of 5 years of experience in clinical research
- 1-2 years working as an Associate Project Manager withing a CRO or Pharma setting
- Vendor management experience
- Excellent knowledge of ICH-GCP, clinical study delivery process, including regulations, operational best practices, industry standards. Well familiar with key systems used in clinical trial delivery. Experience in using Trial Master File industry accepted standard.
- Strong project management skills (preferably with analytical / financial skills) and good leadership skills.
- Excellent verbal and written communication in English.
- Excellent communication and relationship building skills, including external service provider management skills.
