For one of our clients, a Pharmaceutical company located in Parma (Italy), we are looking for a Clinical Trial Supply Coordinator/Manager available 24 hours/week (ideally, 3 days/week: 2 days/week on site and 1 day/week remote/from home office).
Job description
The CTS Coordinator/Manager ensures planning, preparation and distribution of materials for clinical studies (clinical trial supplies), according to projects timelines and GMP standards.
He/She acts in a complex and international environment: he/she contributes to bridge between CMC strategy and clinical development being member of clinical study teams.
The CTS Coordinator/Manager defines and assures that the clinical supplies specifications are aligned to study design, study objectives, geography and regulatory requirements integrating within CMC departments.
Responsibilities
- Act as part of a centre of excellence for GMP activities and preparation of clinical trial supplies for global clinical trials
- 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
- 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 and specific training on IMPs at the Investigator Meetings and CRA meetings or Site Initiation Visit
Requirements
- Scientific degree (Pharmacy, Biotechnology or Biology)
- At least 2-3 years’ experience in a CTS Coordinator or CTS Manager position
- Fluent in English and at least intermediate level in Italian (both written and oral)
- Good knowledge of drug development
- Good knowledge of GMP and good attitude in managing GMP documentation
- Knowledge of GCP and clinical research
- Net-working and team working
- Action and results driven
- Orientation toward efficiency
- Orientation toward the clients
- Ability to manage stress
- Intuitive skills
- 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