Clinical Scientist (NOVJP00026191) (m/f)

REFERENZNUMMER:

372897/29

IHRE AUFGABEN:

-Author of the Clinical Study Protocol, amendments and related documents, Informed Consent Form, Study Operations Manual, monitoring plan, and other study essential documents as applicable
-Train and support CRAs/CROs on study protocol and related questions and serve as point of contact for managing/answering questions relating to trial procedures and subjects’ eligibility
-Responsible for the Clinical Study Report writing and publication of studies, either directly contributing to and managing the report writing, or by liaising with the medical writing/narrative group to ensure report is completed according to current requirements
-Responsible for the set-up and maintenance of the Trial Master File (TMF) for studies, ensuring all relevant study documents are filed and archived at the end of the study according to the appropriate guidelines
-Contribute to the evaluation of clinical sites and external service providers performing TM studies in healthy volunteers and patients
-Responsible for the coordination of pre-audit activities for nominated projects ensuring a satisfactory outcome is achieved, and address corrective actions
-Provide advice to other departments and line functions and to cross-functional working groups as required. Function as a Subject Matter Expert as assigned
-Identify areas for process or technology improvements
-Responsible for following best practices and standards for trial management within TM; expected to share lessons learned
-Maintain knowledge of ICH-GCP, external regulations and procedures, and supplement by training and practice of Novartis SOPs and internal policies. Assist or perform training for CTA and Clinical Scientists

IHRE QUALIFIKATIONEN:

-PhD level scientist with life sciences background; PharmD; BSc or MSc in life sciences
-Business-level oral and written English
-Relevant and demonstrable experience in clinical research / bio-banking / biomarker development and non-drug studies
-Preferably, also experience in clinical trials in healthy volunteers and patients
-Good knowledge of Good Clinical Practice
-Track record of successfully managing multiple early phase clinical research studies / projects and/or clinical trials concurrently (or equivalent)
-Office and clinical trial software IT computer literacy and good overall awareness of modern information technology
-Operational project management experience including excellent planning, prioritization, problem solving and organizational skills
-Used to managing multiple priorities
-Clear written and verbal expression of ideas, an active/proactive communicator
-Used to working independently and in a team environment, being flexible and adapting in a changing environment

WEITERE QUALIFIKATIONEN:

R&D scientist