Clinical Trial Manager (m/f)

REFERENZNUMMER:

310549/11

IHRE AUFGABEN:

-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

IHRE QUALIFIKATIONEN:

-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

WEITERE QUALIFIKATIONEN:

Clinical project manager