Job OfferCSM 2022_09
Duties / Responsibilities:
Under the responsibility of the Clinical Operations Director, the responsibilities will be:
- Primary Responsibilities
The Clinical Study Manager is responsible to provide the operational expertise to ensure the effective and efficient delivery of all operational aspects of one or more studies through all phases of clinical Study Management (Plan, Initiate, Conduct, Close), in accordance with the appropriate quality standards including ICH/GCP and applicable regulations. The suitable candidate achieves this by delivering high quality study management support and other high value services to enable team and project success.
- Secondary Responsibilities
Somno-Art studies management (Medical Device)
Specifically, these duties are to:
- Be responsible for Somno-Art projects (Medical Device): training users to the Somno-Art solution, logistic management, data management (data reception, analysis of recordings), keeping the documentation up-to-date, ongoing communication with clients/partners using the Somno-Art solution.
- Assist in Management of clinical studies including investigators selection, analysis of potential patient recruitment, organizing and leading investigator meetings as well as developing key study documents (protocols, relevant source documents, informed consents, clinical trial agreements, Monitoring Plan).
- Ensure that studies are conducted with full adherence to the study protocol, SOPs, applicable regulations, and principles of Good Clinical Practice (GCP).
- Contribute to develop the clinical study budget.
- Ensure clinical studies are conducted in a timely manner and within predefined budgets.
- Communicate with external vendors and ensure timely delivery and reviews of documents generated by external parties.
- Contribute to the Quality Control of all deliverables received from external parties.
- Coordinate the scheduling and management of all trial-related conference calls.
- Responsible for assisting in the development, implementation, maintenance and archiving of Clinical Trial Master File.
- Perform site-study initiation, interim monitoring and close out visits as required.
- Ensure and assure quality of the data collected on site according to ICH-GCP, SOP and study protocol.
- Assist the Project Managers on assigned projects and will take a lead role where required.
- Coordinate responses to study questions or issues from Health Authorities or IRBs/IECs.
- Be responsible for the preparation of reports, documents, statistical surveys and other data as required.
- Assume additional responsibilities as needed, with little or no supervision.
- Provide support to other positions as needed.
- Assist Directors in the creation and maintenance of internal policies and SOPs.
- Be Willing and able to travel.
Qualification / Education
- Bachelor degree in a scientific discipline. Or Study manager with experience of managing trials globally, leading and coordinating the implementation activities in multiple countries
- Strong understanding of clinical trials, study design and proper ICH/GCP knowledge and training
- Excellent MS Office applications skills, especially well-versed in the use of Excel
- Excellent oral and written communication skills
- Excellent communication and customer service skills, which enable successful collaboration with executive level stakeholders internally and externally
- Demonstrated ability to think strategically when planning, managing teams, and managing processes
- Fluent in English
- Previous experience in dealing with 2-3 studies in parallel
- Experience and success working in a busy team environment under time pressure
- An experience with Medical device would be an advantage