Job Description Clinical research is at the core of drug development and is key to provide society with innovative medicines. Through this program, Novartis offers a unique opportunity to gain insights into the different aspects of clinical trials, to develop your skills and to collaborate in an international environment on cutting-edge projects.
Who we are: Clinical Sciences & Innovation (CS&I) is playing a key role in the planning and execution of Novartis’ early phase clinical trials. From First-in-Human to Proof-of-Concept, dedicated teams design and operationalize clinical trials, ensuring a smooth and efficient transition of newly developed therapies from the bench to the clinical frame. With patient centric and innovative mind-set, we play a pivotal role in translating discovery research into clinical applications.
Opportunity: As part of CS&I’s commitment to talent development, we offer a unique opportunity (1 year fellowship) to selected NIBR/FMI post-doctoral fellows to gain experience in the field of clinical research as Clinical Trial Associate (CTA).
We are looking for highly motivated "NIBR/FMI post-doc associates" seeking to transfer their basic research skills/scientific expertise and to gain exposure to the various aspects of clinical trial management. As part of our team, you will support Clinical Study Leads on their day to day activities, contributing to the planning and execution of early-phase trials. You will have to collaborate both internally and externally by prioritizing and delivering on tasks across multiple studies. Your curious and innovative mind-set will be an asset.
Key responsibilities will include: • Supporting assigned clinical trial teams (CTT) with study tasks, across multiple therapeutic areas (non-oncology), to ensure the trial deliverables are met according to timelines and budget. • Assist in the preparation and management of clinical and regulatory study-essential documents. •Support the set-up and maintenance of the Trial Master File • Audit existing Paper Trial Master Files, collect outstanding documents and archive after study is completed • Collaborate with internal partners including TMDP, global clinical supply, data management, regulatory, biostatistics, PK sciences, biomarker development • Assist in the ordering of clinical trial supplies. • Assist in the compilation of the Clinical Study Report and its appendices • Provide input on agendas, create materials, and liaise with meeting planners / coordinate logistics for key meetings; e.g. internal meetings or external investigator meetings • Manage and track trial information databases, ensuring their accuracy • Ensure compliance to internal Novartis processes and Good Clinical Practice guidelines
Minimum requirements• PhD in life sciences • Being currently enrolled in the NIBR/FMI post-doctoral program in Basel and close to completion or being within six months since program completion is a must •Previous experience/knowledge in a clinical trial setting and awareness of the principles of Good Clinical Practice is an advantage • Demonstrated organizational skills and ability to multi-task and prioritize them in order to deliver on timelines • A detail, quality and compliance focused approach to projects • Strong change agility. Ability to pro-actively learn, solve issues and take accountability • Good collaboration skills with ability to work in a team, interact with and influence a wide range of people • Clear written and verbal expression of ideas; active communicator • Fluent oral and written English
Please submit your CV and cover letter until August 25, 2019 for consideration
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