Description
We are looking for a
Clinical trial manager (m/f)
Reference: -en
Start: asap
Duration: 12 MM++
Place: in the Basel region
Branch: Herstellung von pharmazeutischen Erzeugnissen
Your tasks:
- Assist in all aspects of trials, work closely with and also provide regular updates to the global trial manager
- Liaise with key stake holders, e.g. regulatory, clinical trial supplies, data management, quality assurance, legal, finance etc. for study deliverables
- Ensure trial conduct in adherence to GCP, company SOP, local guidelines and policies, e.g. collaborate with CRAs on-site selection and setup, patient recruitment and also data collection
- Participate in investigator meetings and training of CRAs and assist CRAs with addressing study related questions from investigators
- Ensure collection and approval of essential documents and also timely deliver study supplies for the study commencement
- Collaborate regularly with service providers in relation to central labs, IMP management via IVRS to support and address study related issues affecting allocated countries
- Responsibility for the direct management of CRO and ensure that all delegated tasks are executed per GCP, company SOP and local laws within agreed timelines and budget
Your qualifications
- Solid experience in clinical trial management, vendor management and budgeting
- Proven field monitoring experience is beneficial
- Knowledge of clinical trial processes
- Experience in executing a wide range of trial activities from initiation to study report
- Experience with working in a global matrix environment
- Solid understanding of the international council of harmonisation
- Fluent English language skills
Skills:
- Clinical project manager
Keywords: Clinical Project Manager