Clinical Trial Supply Coordinator
5 giorni fa
On behalf of our Client a global pharmaceutical company, IQVIA is looking for a **Clinical Trial Supply Coordinator** who can join an exciting working environment in a dynamic atmosphere.
**RESPONSIBILITIES**:
The CTS Coordinator acts in a complex and international environment.
- Develop packaging design solutions for clinical trial materials tailored for patient compliance and site staff needs
- Develop innovative solutions for comparator blinding and conversion into matched placebo
- Develop the clinical trial supplies plan included the related risk management plan according to clinical study timelines and budget
- Develop the clinical trial supplies distribution plan according to sites' recruitment rate and enrolment plan
- Prepare the treatment section of the clinical study protocol and clinical study report
- Execute the preparation of clinical trial supplies according to the clinical protocol and to the clinical trial supply plan, budget and timelines
- Execute the distribution of clinical trial supplies according to the clinical trial supply distribution plan, budget and timelines
- Contribute to the definition of outsourcing/insourcing strategy for the assigned clinical trial supplies blinding, packaging & labelling and distribution activities and define the related budget
- Contribute to the technical evaluation of the CTS Department providers
- Prepare batch record documentation or review the providers' batches record documentation (in case of outsourced activities) for the blinding, packaging and labelling of clinical trial supplies
- Design, print or supply (in case of outsourced activities) Mono and Multilanguage IMPs labels
- Contribute to the selection of the IRT provider
- Contribute to the requirements set-up and validation of IRT
- Deliver presentation of study drugs at the Investigator Meetings and CRA meetings or Site Initiation Visit
- Act as part of a centre of excellence for GMP activities and preparation of clinical trial supplies for global clinical trials
**REQUIREMENTS AND SKILLS**:
- At least two years' experience in similar role
- Scientific degree (CTF, Pharmacy, Biotechnology or Biology)
- Good knowledge of drug development
- Good knowledge of clinical research
- GMP and GCP
- Networking and team working
- Action and results driven
- Orientation toward efficiency
- Orientation toward the clients
- Ability to manage stress
- Capable of analysing, resuming and interpreting information
- Capable of planning and anticipating actions according to priorities and deadlines
- Capable of working efficiently with various teams
- Capable of creating and maintaining good relations
- Fluent English
**TYPE OF CONTRACT**:
Permanent contract
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