What are the responsibilities and job description for the Clinical Supply Operations Specialist position at ICON Strategic Solutions?
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.
Responsibilities
Supply Planning: Prepares clinical logistics systems for inputting and tracking IP shipments, temperature excursions, and product expiry for molecules across multiple Therapeutic Areas.
Inventory Tracking & Shipments: Independently initiates IP shipment orders according to supply plans or as requested by Clinical Logistics Manager or Clinical Trial Management team; tracks orders from shipment through receipt at investigator study sites; communicates with distribution vendors to ensure timely and compliant shipment and delivery to investigator sites.
Temperature excursions: Processes, reviews and evaluates temperature excursion reports from clinical sites and communicates stability information and/or product acceptability to clinical trial managers, CROs, and investigator sites.
Returns & Destruction: Provides support in reviewing, tracking and/or archiving IP returns documentation.
Expiry Management: Monitors IP expiry data and informs Clinical Supply team and Clinical Trial teams of pending IP expiry.
Ancillary Supplies: Facilitates ancillary supply shipments to investigator sites. Manages in-house inventory.
Documentation: Ensures appropriate documentation of IP supply activities is provided to clinical trial teams for the Trial Master File.
Study Team Interaction: Interacts with Clinical Study teams to act on specific trial needs. Works with functional groups to provide and receive information required for achievement of individual or team assignments, goals and objectives. Analyzes issues and uses judgment to elevate issues to the appropriate team members for consideration and resolution
Vendor Management: Interacts with vendors to act on specific trial needs. Assists with vendor management and troubleshooting.
Process Initiatives: Assists with implementing process initiatives in accordance with business needs.
Metrics: Tracks metrics related to drug supply processes.
Training: May assist in training and development as needed.
Reporting: Compiles reports of supply status to study teams and clinical logistics team as needed.
Problem solving: Applies knowledge of company policies and standard practices to resolve problems.
Does not supervise staff.
Education Requirements
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
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.
Are you a current ICON Employee? Please click here to apply
Responsibilities
Supply Planning: Prepares clinical logistics systems for inputting and tracking IP shipments, temperature excursions, and product expiry for molecules across multiple Therapeutic Areas.
Inventory Tracking & Shipments: Independently initiates IP shipment orders according to supply plans or as requested by Clinical Logistics Manager or Clinical Trial Management team; tracks orders from shipment through receipt at investigator study sites; communicates with distribution vendors to ensure timely and compliant shipment and delivery to investigator sites.
Temperature excursions: Processes, reviews and evaluates temperature excursion reports from clinical sites and communicates stability information and/or product acceptability to clinical trial managers, CROs, and investigator sites.
Returns & Destruction: Provides support in reviewing, tracking and/or archiving IP returns documentation.
Expiry Management: Monitors IP expiry data and informs Clinical Supply team and Clinical Trial teams of pending IP expiry.
Ancillary Supplies: Facilitates ancillary supply shipments to investigator sites. Manages in-house inventory.
Documentation: Ensures appropriate documentation of IP supply activities is provided to clinical trial teams for the Trial Master File.
Study Team Interaction: Interacts with Clinical Study teams to act on specific trial needs. Works with functional groups to provide and receive information required for achievement of individual or team assignments, goals and objectives. Analyzes issues and uses judgment to elevate issues to the appropriate team members for consideration and resolution
Vendor Management: Interacts with vendors to act on specific trial needs. Assists with vendor management and troubleshooting.
Process Initiatives: Assists with implementing process initiatives in accordance with business needs.
Metrics: Tracks metrics related to drug supply processes.
Training: May assist in training and development as needed.
Reporting: Compiles reports of supply status to study teams and clinical logistics team as needed.
Problem solving: Applies knowledge of company policies and standard practices to resolve problems.
Does not supervise staff.
Education Requirements
- Bachelor’s Degree
- Relevant clinical supply management experience within the biotechnology/pharmaceutical industry preferred
- At least 3 years relevant experience in the following fields: Clinical Supplies, QA/Regulatory, Precision Medicine, Supply Chain, or Manufacturing
- Fundamental knowledge of the clinical drug development process and relevant cross-functional partners
- Fundamental knowledge of International Council of Harmonization (ICH) / Good Clinical Practices (GCP) & regulatory guidelines/directives
- Proficiency with MS Word & Excel
- Efficient and effective problem solving and time management skills
- Action oriented with high level of agility and adaptability
- Collaborates and communicates effectively
- Excellent organizational skills with highly detail-oriented approac
- Work in client office (Warren NJ) 3 days/week
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, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.
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.
Are you a current ICON Employee? Please click here to apply