Clinical Scientist (m/f)

REFERENZNUMMER:

294532/11

IHRE AUFGABEN:

-Work according to the clinical development plan as approved
-Lead the development of core clinical study documents such as protocol summaries, study protocols, study fact sheets, protocol amendments, and study reports (this includes the drafting and the review process until final approval of the documents)
-Review and provide input to internal and external clinical study documents with scientific content, including, among others, Inform Consent Form, Statistical Analysis Plan (SAP), Case Report Form, laboratory and analytical documentations
-Participate in the review of clinical study data according to the Data Review Plan and in the review of the clinical results such as tables, figures, listings (TFLs) and other analyses according to the SAP
-Ensure that the study documentation is developed in compliance with standard clinical research practices (ICH-GCP), in particular with respect to subject assessment of eligibility, enrolment, clinical safety (adverse events, serious adverse events), data consistency, as well as the quality management system applicable to the PMI RnD environment
-Support and actively participate in clinical operations activities requiring scientific input such as internal and external meetings, including investigator meetings, discussions with CRO/vendors/third parties etc.
-Actively contribute to the clinical assessment team activities (e.g. assessment plans, presentations, publications, literature searches), duties, interactions with other functions and with external stakeholders and/or 3rd parties
-Support the clinical study team and other functions (regulatory, quality, safety) in the resolution of issues and crises

IHRE QUALIFIKATIONEN:

-Scientific degree (MD, PharmD or PhD) preferred and/or equivalent demonstrable skills
-Profound experience in clinical research (academic, pharmaceuticals, medical devices, CRO)
-Experience in the planning, executing and reporting of clinical studies
-Thorough knowledge of clinical research, including ICH/GCP guidelines, clinical trial documents, clinical trial design, statistics and regulatory processes
-Fluency in English
-Understanding of basic statistical methods
-Proficiency in performing literature review
-Familiarity with document storage and systems
-Familiarity with working according to a quality management system

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WEITERE QUALIFIKATIONEN:

Clinical project manager, R&D scientist