Clinical Study Manager (m/f)

REFERENZNUMMER:

297978/11

IHRE AUFGABEN:

-Coordination of the execution of the assigned clinical studies
-Lead the Clinical Study Team in all operational aspects of the study, including supervision of the CROs, investigational sites, labs and other external/internal stakeholders involved
-Coordination of the preparation of study related documents (e.g. Protocol Outlines, Protocols, Informed Consent Forms, Diary Case Record Forms, Study Report etc.)
-Supervision of monitoring activities, including contribution to the monitoring plans, review of monitoring reports, follow-up letters and co-monitoring visits
-Ensuring that studies are executed with full adherence to ICH GCP, Declaration of Helsinki and any relevant guidelines and regulations
-Support other Clinical Study Managers in execution of other clinical studies (review of documents, co-monitoring, review of planning/budgets etc.)
-Support Manager of Clinical Operations in the CRO selection process, including site pre-selection visits, participation in bid defence meetings and assessment of proposals
-Track the progress of activities contracted to providers and investigators and ensure their completion according to defined quality, timelines and costs
-Reviews of study budgets, invoices and agreements in close collaboration with the Business Management team
-Support the Clinical Assessment group in revision/preparation of selected SOPs and document templates
-Maintain up-to date knowledge of GCPs and relevant regulations

IHRE QUALIFIKATIONEN:

-Profound experience in the management of clinical studies, clinical trial monitoring in a pharmaceutical company or a CRO
-Experience in management studies in USA and Japan
-Experience in the management of post marketing studies and epidemiological studies is of advantage
-Fluency in English (oral and written)
-Strong interpersonal skills and strong team player mentality
-Proficiency in MS Office, capacity to adapt to other IT tools
-Knowledge of other languages (e.g. Japanese) is of advantage

WEITERE QUALIFIKATIONEN:

Clinical project manager