Clinical Study Manager (m/f)

REFERENZNUMMER:

262497/11

IHRE AUFGABEN:

-Accountable for planning of activities, monitoring of the progress and coordination and supervision of the CROs (Clinical Research Organisation), investigational sites, labs and other external/internal stakeholders involved in the study execution
-Monitor Phase I and Phase II
-Manage the Clinical Study Team and all operational aspects of assigned clinical studies
-Coordinate the preparation of study-related documents (e.g. protocol outlines, protocols, informed consent forms, diary case record forms, study report etc.)
-Ensure timely delivery and reviews of documents generated by external parties
-Contribution to above mentioned documents (input, reviews, quality checks)
-Responsible for strict supervision of monitoring activities (conducted by CROs monitors) including definition of monitoring plans, review of monitoring reports, follow-up letters and co-monitoring visits
-Ensure 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
-Contribute to the Quality Control of all deliverables received from CROs & investigators
-Maintain up-to-date knowledge of GCPs and relevant regulations and support clinical assessment group in revision/preparation of selected SOPs and document templates

IHRE QUALIFIKATIONEN:

-Profound experience in the management of clinical studies, clinical trial monitoring in a pharmaceutical company or a CRO
-Previous experience in executing studies in the EU, especially in Poland
-Previous experience in dealing with 2-3 studies in parallel
-Previous experience in quality assurance/quality control is an asset
-Fluency in English

WEITERE QUALIFIKATIONEN:

Clinical project manager