Site Investigational Product Specialist

Site Investigational Product Specialist

ICON plc is a world‑leading healthcare intelligence and clinical research organization. We foster an inclusive environment and drive innovation and excellence. Join us on our mission to shape the future of clinical development.

What you will be doing:

You will be dedicated to one of our global pharmaceutical clients, a company that values performance, recognises merit and focuses on quality. You will serve as the key contact point between the sponsor and the investigational site for Investigational Product Preparation Instructions (IPPI) training of studies with a complex IP preparation process. Your role will focus on IPPI review, training/implementation of IP preparation steps for all compounds requiring training plans, and serve as the key internal and external interface to ensure overall IPPI adherence. You will contribute to continuous process improvement, training and mentoring for IPPI.

The tasks undertaken are varied and can include:

• Play a key role in the safe, efficient and effective Investigational Product preparation and administration in clinical trials.
• Review and provide input on Investigational Product Preparation Instructions Site Investigational Product Procedures Manual, monitoring guidelines and all specific forms related to Investigational Product preparation and dosing before finalization as applicable.
• Process risk assessment review where applicable.
• Close collaboration with the Drug Product Development team and the Drug Preparation Administration Team.
• Early connection with investigational site pharmacy and nursing staff to review site IP process and equipment.
• Close collaboration with GTL, SM, TM, IDM and Pharmacy Investigational Product Specialist for all IPPI related topics.
• Evaluate and support process for IP ancillary supplies/administration kits compatible with the site equipment/practice in the country/investigational site.
• Review site's dispensing and accountability records to ensure key information is captured to confirm dose delivery and administration is documented e.g. infusion rates/volumes.
• Collaboration on Investigational Product training material development with key stakeholders.
• Observe first dosing on site and/or support SM/IDM/PIPS if allowed according to local guidelines and blinding requirements.
• Point of contact for the internal study team in the country for questions related to the IP administration.
• Review any modification of IPPI, SIPPM manual, specific forms related to IP administration and dosing during the applicable phases of the trial.
• Establish and maintain good and productive working relationships with internal and external stakeholders (e.g. nurses, investigators…).

You are:

• A degree in general nursing is required.
• 3-5+ years of recent clinical/hospital experience, including clinical trial research experience.
• Experience in antibody treatment, oncology (hematology and solid tumor) and/or immunology therapeutic area.
• Minimum 3 years’ experience with various IP administration routes (IV, SC, IM); additional routes (intravesical, intraperitoneal, blood‑ and cell products) and priming and flushing procedures may also be required.
• Extensive knowledge of administration related requirements (anatomy and physiology, drug metabolism, IP handling, hygiene and hazardous drug handling).

What ICON can offer you:

Our success depends on the quality of our people. We prioritize building a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of benefits focused on well‑being and work‑life balance.

Our benefits include:

• Various annual leave entitlements
• Health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings.
• Global Employee Assistance Programme, LifeWorks, offering 24‑hour access to a global network of over 80,000 independent specialized professionals.
• Life assurance
• Flexible country‑specific optional benefits including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized 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 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 you need a reasonable accommodation for any part of the application process, please let us know or submit a request here.

Interested in the role, but unsure if you meet all the requirements? Apply regardless – we look for the right fit.

Are you a current ICON employee? Please click here to apply.