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ICON plc has an ongoing need for a Site Activation Lead and Senior Site Activation Lead in Canada. In this role you will be accountable for initiating investigator site activities, study regulatory maintenance activities as well as management of site changes.
Join ICON as fully dedicated to one sponsor in our embedded model! Apply today and find out for yourself why ICON was named Americas the best large employers by Forbes Magazine for 2023
What you will be doing.
- Initiate investigator site activities, including:
- collection and submission of regulatory documents
- customization and negotiation of informed consent form (ICF) documents
- serve as the point of contact for a site’s institutional review board (IRB)
- track and ensure site compliance to required training
- Study regulatory maintenance activities including, but not limited to:
- Informed Consent Form (ICF) updates resulting from amendments and addenda, IB/Risk profile changes, etc.
- Management of site changes:
- Personnel (PI, Sub-I, Study Coordinators, etc.)
- Location
- Site-specific recruitment, patient facing material, and patient reimbursement
- Effectively drive timelines aligned with company priorities. Communicate directly with sites to enable start-up and maintain an active collaboration with sites
- Identify, communicate, and resolve issues
- Ensure country specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems
- Leverage previous site / review board engagements to efficiently drive new work
- Populate internal systems to ensure accuracy of trial / site performance
- Populate Trial Master Files and libraries for future reference
- Provide feedback and shared learning for continuous improvement
- Leverage trial prioritization
- Anticipate and monitor dynamically changing priorities
What we look for (minimum qualifications):
- 2 years of clinical and 2+ year of experience in a clinical site activation environment
- Minimum Bachelors’ degree
- Must have recent experience working for a Pharmaceutical company, biotech or a CRO.
- Management of roughly 25-30 sites in regulatory activation per FTE
- Understanding of the overall clinical development paradigm and the importance of efficient site activation
Benefits of Working in ICON:
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.
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, 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.
