Clinical Trial Scientist (m/f)

REFERENCE NUMBER:

395795/4

MY DUTIES:

-Delivering the following study-related documents: Protocol and Core Informed Consent Form (CICF), Clinical Study Report (CSR)
-Contribute to the following documents generated by other departments: Data Review Manual, Statistical Analysis Plan (SAP), Dummy tables, Case Report Form (design, completion), External Service Providers' (ESP) user requirements and data transfer specifications (DTS) and Review of medical coding
-Accountable for the study-related activities
-Scientific/medical training of the CLINICAL TRIAL TEAM (CTT) MEMBERS
-Steering Committee (SC) management (including charter)
-Independent Data Monitoring Committee (IDMC)
-Event Committee (including charter)
-Protocol Deviations (PDs) management
-Review of non-medical coding
-Filing of study documentation

, Medical monitoring, Data interpretation -Answer to Independent Ethics Committee/International Review Board (IEC/IRB) questions
-Safety monitoring
-The creation and/ or the update of assigned GCS&E-related Quality System documents
-The creation or the implementation of new processes within Clinical Development

MY QUALIFICATIONS:

-PhD, PharmD, DVM, MSc or equivalent degree in Biological Sciences
-Clinical research experience in the indication relevant to the Clinical Project is preferred
-Computer literate
-Fluent in English
-Good organizational skills, able to work as part of a team and independently
-Willingness and drive to assume the responsibility of major Global Clinical Science & Epidemiology (GCS&E) deliverables
-Data oriented
-Open communication: communicates in clear and simple terms, foster communication between different departments, identifies and understands needs of colleagues and customers
-Adapting and responding to change (Innovation): initiates and manages change and improvement, sees and communicates change in an optimistic way, looks externally for new ideas and methods, constantly challenges status quo thinking and knowledge
-Willingness and ability to travel on an international basis

MY BENEFITS:

-Fascinating, innovative environment in an international atmosphere
-Interesting assignments at renowned national and international companies

ABOUT HAYS:

With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.

MY CONTACT AT HAYS:

My contact person
Eden Lara Gordon

Reference number
395795/4

Contact
E-Mail: [email protected]