Clinical Trial Leader II

Welcome to Novartis - the company that considers its employees to be its greatest asset. Good Business. Great Opportunities. How do you spend your day? Are you passionate about what you do? At Novartis, our focus is clear, our purpose defined. We're part of a team that's making a difference in the quality of people's lives.Think What's Possible.Responsible for the planning and implementation of all operational aspects of assigned Translational Medicine (TM) studies (e.g. medium to high complexity studies; first in man, patient studies, multi-center studies, mechanistic studies) from synopsis to reporting according to timelines, budget, operational and quality standards (ICH/GCP/Novartis SOPs and procedures). Major Activities1. Accountable for the writing of clinical protocols and related documents in collaboration with the Clinical trial Team (CTT)2. Lead and manage the global multidisciplinary CTT to ensure all trial deliverables are met according to timelines, budget, quality standards and operational pro-cedures3. Function as a Lead CTL on studies for Full Development and assist in the coordination of TM related submission documents4. Responsible for ordering and management of clinical trial materials, including drug supplies and CRFs5. In collaboration with CRO management, CTT and CRAs, identify sites and manage study set-up, including responsibility for organizing and chairing the Initiation meeting 6. Support the CRA on study related questions and serve as point of contact for managing/answering questions relating to trial procedures and subjects eligibility7. Responsible for set up and maintenance of the Trial Master File for assigned studies.8. Regularly update all trial information databases in order to manage accuracy of information 9. Approve for all necessary center payments as per financial agreements.10. In collaboration with the TME and CTT, lead the ongoing review of the clinical trial medical/scientific data (as needed), analysis and interpretation including the devel-opment of first interpretable results, clinical trial reports, publications and internal/external presentations. 11. Co-ordinate pre-audit activities for nominated projects ensuring a satisfactory outcome is achieved.12. Contribute to identification and evaluation of new centers suitable for performing TM studies in healthy volunteer and patients.13. Responsible for implementation of best practices and standards for trial management within TM, including sharing lessons learned.14. Provide TM Scientific Operations expertise to other departments and line functions through e.g. cross-functional working groups or TM Initiatives.15. Contribute to talent and career development of TM staff through active participation in on-boarding, training and mentoring activities.QualificationsBSc or MSc in life sciences or nursing; PhD level scientist with life sciences background; PharmD.Fluent English (oral and written), knowledge of a second language is desirable. Novartis is committed to embracing and leveraging diverse backgrounds. Novartis is an equal opportunity employer M/F/D/V.To apply for this position, Click HereTo learn about other Novartis opportunities, Click Here Link to Novartis Pharmaceuticals opportunities Send this Job to a Friend EEO Novartis is committed to embracing and leveraging diverse backgrounds. Novartis is an equal opportunity employer M/F/D/V.