Site Investigational Product Specialist

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ICON plc

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Pharmaceuticals • Biotechnology • Healthcare Insurance

ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.

10,000+ employees

Founded 1990

💊 Pharmaceuticals

🧬 Biotechnology

⚕️ Healthcare Insurance

📋 Description

• You will be dedicated to one of our global pharmaceutical clients, a company that values performance, recognises merit and has a high focus on quality. • The Site Investigational Product Specialist will serve as a 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. • This role will focus on IPPI review and training/implementation of IP preparation steps for all compounds deemed requiring training plans. • The Site Investigational Product Specialist will be the key internal and external interface to ensure overall IPPI adherence. • He/she 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 (Global Trial Lead) GTL, (Study Manager) SM, (Trial Manager) TM, Independent Drug Monitor (IDM) and Pharmacy Investigational Product Specialist (PIPS) for all IPPI related topics. • Evaluate and support process for IP ancillary supplies/administration kits are compatible with the site equipment/practice in the country/investigational site. • Review of 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,…).

🎯 Requirements

• A degree in general nursing is required. • 3-4 years of recent clinical/hospital experience is required; • Experience in antibody treatment, (Oncology (hematology and solid tumor) and / or Immunology Therapeutic Area) • Min. 3 years’ experience with various IP administration routes (IV, SC, IM) • Clinical trial research experience. • Minimum of 5+ years of recent clinical/hospital experience is required; however, other relevant experience may be considered by the hiring manager when considering the candidate’s eligibility. • Minimum of 5+ years’ experience with various IP administration routes (IV, SC, IM, intravesical, intraperitoneal, blood- and cell products) and priming and flushing procedures required. • Extensive knowledge on Administration related requirements (background of anatomy and physiology, metabolism of drugs and IP, hygienic requirements, how to handle hazardous drugs).

🏖️ Benefits

• 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.