Clinical Supply Operations Specialist

Posted 7 Days Ago
Be an Early Applicant
2 Locations
In-Office
62K-85K Annually
Mid level
Healthtech • Biotech • Pharmaceutical • Manufacturing
The Role
The Clinical Supply Operations Specialist manages clinical supply logistics, including inventory tracking and documentation, vendor interactions, temperature excursions, and expiry management across trials.
Summary Generated by Built In
Clinical Supply Operations Specialist

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:
  • Bachelor’s Degree
Experience and Skills:
  • 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 approach

  • Work in client office (Warren NJ) 3 days/week

Salary target: $85,000 - actual pay based on experience.

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.

Salary Range

$62,376.00-$77,970.00

Bonus, Com, Stock, Benefits & Disclaimer verbiage:

Actual compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level.   You may be eligible for a bonus, stock compensation and commissions in some cases depending on your role and performance.

Are you a current ICON Employee? Please click here to apply

Skills Required

  • Bachelor's Degree
  • 3+ years of relevant experience in Clinical Supplies, QA/Regulatory, Precision Medicine, Supply Chain, or Manufacturing
  • Fundamental knowledge of the clinical drug development process
  • Knowledge of ICH/GCP and regulatory guidelines
  • Proficiency with MS Word & Excel

ICON plc Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about ICON plc and has not been reviewed or approved by ICON plc.

  • Healthcare Strength Benefits are described as comprehensive, with medical coverage and wellness initiatives highlighted. Larger sites are also associated with added wellness supports such as onsite fitness options and access to an employee assistance program.
  • Leave & Time Off Breadth Time-off and flexibility provisions are positioned as a meaningful part of the total package, including vacation/annual leave and flexible work scheduling. Flexibility is sometimes cited as helping offset long hours in certain roles.
  • Retirement Support Retirement and savings support is presented as a core component of the benefits package, including offerings such as pension arrangements in some locations and a U.S. 401(k) plan with company match. Financial planning resources are also emphasized as part of broader security benefits.

ICON plc Insights

Am I A Good Fit?
beta
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.

The Company
HQ: Dublin
34,685 Employees
Year Founded: 1990

What We Do

Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times. We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.

Similar Jobs

MetLife Logo MetLife

Claim Review- Life - 17765

Fintech • Information Technology • Insurance • Financial Services • Big Data Analytics
Remote or Hybrid
United States
43000 Employees
42K-49K Annually

MetLife Logo MetLife

Consultant

Fintech • Information Technology • Insurance • Financial Services • Big Data Analytics
Remote or Hybrid
United States
43000 Employees
80K-115K Annually

MetLife Logo MetLife

AVP, Business Controls - Global Business Solutions

Fintech • Information Technology • Insurance • Financial Services • Big Data Analytics
Remote or Hybrid
United States
43000 Employees
164K-219K Annually

PNC Bank Logo PNC Bank

Scrum Master

Machine Learning • Payments • Security • Software • Financial Services
Remote or Hybrid
USA
55000 Employees
55K-140K Annually

Similar Companies Hiring

Granted Thumbnail
Mobile • Insurance • Healthtech • Financial Services • Artificial Intelligence
New York, New York
23 Employees
Fortune Brands Innovations Thumbnail
Manufacturing
Deerfield, IL
2450 Employees
Amalgamated Sugar Thumbnail
Food • Greentech • Agriculture • Industrial • Manufacturing
Boise, Idaho
768 Employees

Sign up now Access later

Create Free Account

Please log in or sign up to report this job.

Create Free Account