Clinical Study Manager - Switzerland
The successful candidate will join the Clinical Assessment group in Neuchâtel, Switzerland. The primary objective of this team is to assess a new range of products.
You will be responsible for the implementation and execution of those clinical studies assigned to you. This will include study planning and also monitoring the progress and managing all external and internal partners involved in the study.
Specifically, you will:
*Be accountable for the planning of activities, monitoring of progress and coordination and supervision of the Clinical Research Organizations (CRO), investigational site(s), laboratories and all other external and internal stakeholders involved in the study.
*Manage the Clinical Study Team and all operational aspects of the studies assigned to you.
*Coordinate the preparation of study related documents, such as Protocol Outlines, Protocols, Informed Consent Forms, Diaries, Case Record Forms, Study Reports etc.
*Support the Manager of Clinical Operations during the CRO selection process including site pre-selection visits, bid defense meetings and assessment of proposals.
*Ensure timely delivery and review of all documents generated by external parties.
*Be responsible for strict supervision of monitoring activities including definition of monitoring plans, review of monitoring reports, follow-up letters and co-monitoring visits.
*Ensure that all studies assigned to you are executed in compliance with International Conference on Harmonization (ICH) Good Clinical Practice (GCP), Declaration of Helsinki and any other relevant guidelines, regulations or quality standards that may be appropriate.
*Track the progress of all activities contracted to third party providers and investigators to ensure their completion according to defined quality standards, timeline and costs.
*Take responsibility for the collection, review and Quality Control of all essential documents received from CROs & investigators.
*Confirm the completeness of Study Master Files.
QUALIFICATIONS
*Ph.D or Masters Degree in the Life Sciences together with at least three to five years practical experience in the management of clinical studies and /or clinical trial monitoring in a pharmaceutical or biotechnology company or a CRO
*Previous experience in Quality Assurance / Quality Control would be an asset
*Solid project management skills including use of tools such as MS Project, MS Office etc
*Previous experience of executing studies outside Europe would be an asset
*Practical working knowledge of ICH GCP and methodology of execution and monitoring of clinical studies
*Knowledge of electronic document management systems would be an asset
*Fluency in spoken and written English is a must, knowledge of additional languages, particularly French, would be an asset.
You will be part of the Research & Development Department, whose primary mission is to research and develop new products .
You will benefit from our dynamic team of professionals, working in a multicultural environment.
We offer an excellent salary and benefits package as well as a relocation allowance (where appropriate).Paramount Recruitment Limited provides services as an agency and an employment business. We regularly have similar roles in this area. Please see our website for details or send your CV in to us to find out the latest opportunities.