Trial Manager (m/f)

REFERENZNUMMER:

337711/11

IHRE AUFGABEN:

-Assist in all aspects of trials, work closely with and also provide regular updates to the global trial leader
-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 in 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
-Create the global investigator budget and payment schedules
-Preparation and review of all trial-related documents
-Responsibility for the direct management of CRO and ensure that all delegated tasks are executed as per GCP, company SOP and local laws within agreed timelines and budget

IHRE QUALIFIKATIONEN:

-Profound experience in clinical trial management and preferably a sponsor and/or CRO with a clear focus on phase I and II
-Solid knowledge of vendor management and budgeting
-Proven field monitoring experience is beneficial
-Experience in executing a wide range of trial activities from study start-up to study report
-Experience in working in a global matrix environment
-Proven track record of managing clinical trials in accordance with pre-set timelines, budget and quality expectations
-Fluent English language skills

WEITERE QUALIFIKATIONEN:

Clinical project manager