DOCS Manager, Clinical Logistics in Helena, Montana
Manager, Clinical Logistics
Ref #: 32783
Employment type: Permanent - Full-Time
Location: United States
ICON Global Strategic Solutions is looking for a Manager, Clinical Logistics that will be responsible for forecasting Investigational Product (IP) supply requirements for multiple clinical trials and for managing the IP distribution process to one or more clinical trials. Ensure that activities are performed on time, within budget and with good quality, in compliance with Regulatory Authorities’ regulations / guidelines and SOPs. Candidate will contribute to ongoing process improvement initiatives.
About the Job:
ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations.
With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
What Will You Be Doing:
-Supply Planning, preparing clinical logistics systems for inputting and tracking IP shipments, temperature excursions, and product expiry for molecules across multiple Therapeutic Areas.
-Inventory tracking, tracks investigational product (IP) inventory.
-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.
-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.
-Provides support in reviewing, tracking and/or archiving IP returns documentation.
-Monitors IP expiry data and informs Clinical Supply team and Clinical Trial teams of pending IP expiry.
-Facilitates ancillary supply shipments to investigator sites. Manages in-house inventory.
-Ensures appropriate documentation of IP supply activities is provided to clinical trial teams for the Trial Master File.
-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
-Analyzes issues and uses judgment to elevate issues to the appropriate team members for consideration and resolution
-Interacts with vendors to act on specific trial needs. Assists with vendor management and troubleshooting.
-Assists with implementing process initiatives in accordance with business needs.
-Tracks metrics related to drug supply processes.
-May assist in training and development as needed.
-Compiles reports of supply status to study teams and clinical logistics team as needed.
-Applies knowledge of company policies and standard practices to resolve problems.
What You Need to Have:
-At least 5 years of relevant experience in the biotechnology/pharmaceutical industry, with 3 years minimum in clinical supply management
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.
DOCS is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.