Clinical Study Manager (m/f)

REFERENZNUMMER:

350020/11

IHRE AUFGABEN:

-Responsible for implementation and execution of the assigned clinical studies
-Lead of the Study Team and all operational aspects of the study including supervision of the CROs
-Investigational sites, labs and other external/internal stakeholders involved in the study execution
-Contribution and coordination of the preparation of study related documents
-Supervision of monitoring activities including contribution and review of the monitoring plans, review of monitoring reports, follow-up letters and conduct of co-monitoring visits
-Ensure that studies are executed with full adherence to ICH GCP and any relevant guidelines and regulations
-Support Manager of Clinical Operations in selection process of CROs
-Reviews of study budgets, invoices and agreements in close collaboration with Business Management team
-Accountable for the collection of essential documents and completeness of Study Master Files

IHRE QUALIFIKATIONEN:

-Experience in management of clinical studies
-Previous experience in management of post marketing studies or epidemiological studies is an advantage
-Fluent English (oral and written)
-Strong interpersonal skills and strong team player
-Good knowledge of ICH GCP
-Good knowledge of MS Office
-Working knowledge of electronic document management systems and/or eTMFs

WEITERE QUALIFIKATIONEN:

Clinical project manager