Clinical Study Manager (m/f)

Description

• 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

• 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