Are you ready to take your next step in Clinical Studies!
Our client, an innovative and dynamic global enterprise is seeking for a
Clinical Study Manager Contracted position
Position Purpose / duties:
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 (Clinical Research Organization), investigational sites, labs and other external/internal stakeholders involved in the study execution.
Contribution (input, reviews, quality checks) and/or coordination of the preparation of study related documents, (including but not limited to IB, Protocol Outlines, Protocols, Informed Consent Forms, Diaries Case Record Forms, Study Report etc.). For documents generated by external parties ensures timely delivery and reviews of such 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.
Ensures that studies are executed with full adherence to ICH GCP, Declaration of Helsinki and any relevant guidelines and regulations. Ensures that any compliance issues are escalated to QA / Management and strictly monitors that necessary corrective and preventive actions are put in place.
Supports other Clinical Study Managers in execution of other studies as necessary (review of documents, co-monitoring, review of planning / budgets etc.)
Supports Manager of Clinical Operations in selection process of the CROs including site pre-selection visits, participation to bid defense meetings and assessment of proposals.
Tracks the progress of activities contracted out to providers and investigators and ensures their completion according to defined quality, timelines and costs.
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. Contributes to the Quality Control of all deliverables received from CROs & investigators.
Supports Clinical Assessment group in revision/preparation of selected SOPs and document templates.
Maintain up-to date knowledge of GCPs and relevant regulations
Minimum 3 years experience in management of clinical studies
Previous experience in management of studies in the USA and / or in Japan
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 Suite
Working knowledge of electronic document management systems and/or eTMFs
Knowledge of other languages (e.g. Japanese) is an advantage
If this challenge appeals to you, please do not hesitate to apply, through our online portal or via mail. All applications will be treated in strictest confidence and all applicants will receive a response. For any further questions, please contact David La Framboise (email@example.com).