Senior Study Specialist – Clinical Trial Supply
| Company | CSL |
|---|---|
| Location | King of Prussia, PA, USA, Schwalmstadt, Germany |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Senior |
Requirements
- Bachelor of Science degree, e.g. biology or logistics
- At least 4-5 years of professional experience in clinical research and logistics in the biopharmaceutical industry
- Additional experience in global project management, ideally in an R&D environment
- Knowledge and experience in GCP/cGMP/GDP/ICH
- Fluency in English
- Good presentation skills
Responsibilities
- Planning, implementation and monitoring of a logistics network for assigned simple global clinical trials
- Coordination of worldwide trial supply with internal global departments and external service providers
- Participation in or, if necessary, leading meetings with internal and external expert groups for the provision of clinical trial supplies
- Collaboration on complex global studies in coordination with the supervisor
- Implementation and monitoring of the entire trial supply chain at the study sites
- Creation and revision of study documents
- Training of internal and external stakeholders regarding the handling of the respective product
- Ensuring the SOP-compliant execution of all assigned clinical study activities
- Collaboration in the preparation, execution and follow-up of audits and inspections
- Collaboration in the creation and revision of study-specific software specifications in an IRT system (Interactive Response System)
- Calculation and monitoring of the budget for assigned studies
- Technical collaboration in cross-country and cross-functional projects (e.g. continuous improvement with regard to clinical trials)
Preferred Qualifications
- Experience in global project management, ideally in an R&D environment