Clinical Study Manager (m/f)

REFERENZNUMMER:

245190/11

IHRE AUFGABEN:

-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
-Manages the Clinical Study Team and all operational aspects of assigned clinical studies
-Coordinates 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
-Maintains up-to date knowledge of GCPs and relevant regulations. Supports Clinical Assessment group in revision/preparation of selected SOPs and document templates

IHRE QUALIFIKATIONEN:

-Profound 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 dealing with 2-3 studies in parallel
-Previous experience in Quality Assurance/Quality Control is an asset
-Fluent in Englisch

WEITERE QUALIFIKATIONEN:

Clinical project manager, Clinical trial manager