Description
- Novartis Campus in Basel
Clinical Scientist (NOVJP) (m/f)
Reference: -en
Start: asap
Duration: 18 MM
Main tasks:
- 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
Main qualifications
- 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
Main advantages:
- Working experience at a global player in the pharmaceutical industry
About us:
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.