Senior Clinical Supplies Project Manager
il y a 5 heures
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.
With our patients at the centre 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.
The Role:
- Job Description
- Level-Specific Responsibilities- Assumes team leadership responsibility in the management of end to-end clinical
- Supply chain logistics at the program level.- Develops and assists in the selection of appropriate supply forecast models at program level.
- Coordinates the procurement activities for investigational product, comparator, and other NIMP and/or ancillary supplies at the program level.
- Interprets relevant protocol information to develop packaging/labeling design for high complexity studies.
- Supports design and set-up of IVRS system for high complexity studies.
- Coordinates the origination, proofing and transition of clinical study labels for high complexity studies.
- Manages drug supply delivery timelines with appropriate stakeholders.
- Prepares required documentation and facilitating activities for import and export of clinical supplies.
- Manages global supply inventory for medium to high complexity studies.
- Acts as primary point of contact in communication with all stakeholders to ensure clinical supply logistics are in place to meet program milestones.
- Monitors and manages retest dating for assigned study supplies.
- Resolves clinical supply complaints and addresses supply replacement requests, as required.
- Works closely with appropriate stakeholders to manage clinical supply forecasting and budget requirements at the program level.
- Serves as SME in managing clinical supply logistics.
- Trains and mentors junior clinical supply team members.
- Continually reviews processes and changes needed to improve alignment with customer needs.
- Knowledge, Skills and Abilities- Advanced knowledge of regulations governing investigational products, including GMP and ICH/GCP guidelines
- Expert skills in the management of end to-end clinical supply chain logistics
- Advanced communication, interpersonal, and time management skills
- Ability to work autonomously under general supervision
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.
Are you a current ICON Employee? Please click here to apply:
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