Company Description
PSI is an award-winning full-service CRO, bringing together more than 2,700 dynamic and knowledgeable individuals working to help impact the future of medicine in more than 60 countries around the world. We support pharmaceutical, biotechnology, and medical device companies with the services needed to perform clinical trials of new medicines. Our work helps patients in need improve their well-being - a fundamental driver for many of us to show up and do our best each day.
Job Description
In this role, you will undertake activities to assess, plan and set up trial supply schemes for assigned projects and manage vendors involved in clinical supplies and interactive response technology.
Office-Based in Madrid or Home-based.
You will:
Analyze clinical trial protocols and translate requirements to establish an efficient supply chain solution for PSI studies.
Build and maintain a drug demand forecast in line with planned enrolments.
Plan the optimal campaign strategy to ensure clinical supplies are available in accordance with the project requirements.
Manage the CMO vendor - oversee packaging, labelling, procurement, distribution and QP release activities to ensure supplies are delivered on time.
Manage the IRT vendor - lead study specific system set-up, UAT, system acceptance and ongoing system updates.
Develop clinical supply plans and provide input for the development of vendor management plans.
Participate in the selection of trial supply vendors and IRT vendors for PSI studies.
Support and train PSI teams in clinical supply management.
Liaise with PSI project teams, company divisions, clients and vendors.
Assess risks associated with clinical product management and quality incidences reported by vendors.
Support business development tasks related to clinical trial supply services.
Qualifications
- College or University degree
- 3-5 years' experience in Clinical Supply Chain Management (Essential)
- Experience working with supply chain technologies (i.e. IRT, CTMS, IWRS integration rules and principles)
- Training in GMP and GDP
- Ability to communicate effectively with vendors and internal parties
- Ability to work both independently and in a team environment
- PC skills to be able to work with MS Word, Excel and PowerPoint.
Additional Information
You will work closely with driven and dedicated cross-functional teams, get all support and ownership of your projects. If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.
#J-18808-Ljbffr