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Clinical Study Manager (Long-term Temp. Position)

For one of our partners, an international company based in French-speaking Switzerland, Kelly Scientific is looking for a Clinical Study Manager.
He/she will be responsible for the implementation and execution of assigned clinical studies including study planning, monitoring the progress and management of external and internal partners involved in the study execution.
He/she will contribute to the preparation and review of study related documents (e.g. Clinical Protocols, Informed Consent Forms, Clinical Study Report etc.) and will be accountable for the compliance with the study protocols and adherence to ICH GCP, relevant regulations and best quality standards.
He/she will be responsible for strict supervision of monitoring activities and conduct of co-monitoring visits. This position requires worldwide traveling. He/she deals in general with 2-3 studies in parallel.
Your tasks:
• Accountable for planning of activities, monitoring of the progress and coordination and supervision of the CROs (Clinical Research Organization), investigational sites, labs and other external/internal stakeholders involved in the study execution. Management of the Clinical Study Team and all operational aspects of assigned clinical studies.
• Coordination of the preparation of study related documents, (e.g. 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. Contribution to above mentioned documents (input, reviews, quality checks).
• Responsible for strict supervision of monitoring activities (conducted by CRO's monitors) including definition of 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.
• Responsible for the collection and of essential documents and completeness of Study Master Files. Contributes to the Quality Control of all deliverables received from CROs & investigators.
• Maintaining up-to-date knowledge of GCPs and relevant regulations. Support of Clinical Assessment group in revision/preparation of selected SOPs and document templates.
Your profile:
• 3-5 years experience in management of clinical studies, clinical trial monitoring in a pharmaceutical company or a CRO
• Previous experience in executing studies in USA/Japan
• Previous experience in Quality Assurance/Quality Control, an asset
• Fluent English (oral, written)
• Availability : asap
Long Temp. Position : From September 2014 to June 2016
Should your profile match our requirements, please contact:
Marina Leroy - PhD in Biology - Scientific Recruitment Consultant
Kelly Scientific - Geneva

Region: Neuchâtel
Vertragsart: Befristet
Kategorie: Gesundheitswesen;
Veröffentlicht am: 14.07.14
Beschäftigungsart: Vollzeit (100%)
Job Nummer: JO-1407-11574
Abteilung: Kelly Services, Inc. in Switzerland is a leader in providing innovative workforce solutions. Kelly offers a comprehensive array of custom-designed outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and permanent basis. Kelly provides employment to more than 200 people in over 40 branches and specialist department throughout Switzerland.

Kelly specializes in providing professional/technical workforce solutions, with local expertise. These solutions include Finance, Science, and Medical. Kelly has a rich history in developing our solutions to address the workforce challenges of these communities, with expert staff dedicated to providing integrity and technical competency to ensure high performance, and proven results from its specialty talent.Link megjelenítése" width="0" height="0" />
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