Clinical Study Leader - CV

Novartis Institutes for BioMedical Research is Novartis' global research organization and is committed to discovering innovative medicines that cure disease and improve human health. By conducting more relevant and predictable drug discovery that can yield new and better medicines for patients, Novartis Institutes for BioMedical Research is redefining drug discovery in the post-genomic era. Over the past four years, Novartis Pharmaceuticals has had the greatest number of new molecular entities approved by the US FDA. With its broad focus on diseases for which there is a need for better medical therapies, and with over 3,000 talented, dedicated research scientists worldwide, Novartis Institutes for BioMedical Research is well-positioned to ensure Novartis maintains its strong pipeline and highly successful track record in new drug discovery. Novartis Institutes has sites in Cambridge, Massachusetts (headquarters); Basel, Switzerland; Horsham, UK; East Hanover, NJ; and Emeryville, California. Novartis Institutes' Cambridge facilities encompass 950,000 square feet of laboratory and office space. Research in cardiovascular disease, oncology, infectious disease, diabetes, ophthalmology and muscle disease is headquartered in Cambridge. In addition, Cambridge is home to the following platform technologies: Global Discovery Chemistry, Functional Genomics, Developmental & Molecular Pathways, and Models of Disease Center.In order to attract and develop an exceptionally talented and committed staff, Novartis Institutes for BioMedical Research offers an innovative and comprehensive benefits package, including healthcare, insurance, savings, retirement, and work/life benefits.Novartis is looking to hire a Clinical Trial Leader to join our busy Translational Medicine department. This position will be affiliated with the cardiovascular, diabetes and metabolism (CVM) therapeutic area and will report to the Translational Medicine Operational Head for CVM.You will be responsible for coordinating all operational aspects of early phase clinical studies (including first-in-man, proof of concept and mechanistic/profiling studies) from protocol synopsis to final report. At the study level you will work with and lead a multi-functional team to ensure timely set-up, conduct and reporting, according to ICH/GCP, regulatory requirements and internal SOPs. Duties will include, generation of study synopsis and study protocol, site identification in conjunction with our contracts department, site feasibility assessments, study initiation, oversight and daily management of chosen clinical sites, study timeline and study budget management, coordination of drug supply in conjunction with our Drug Supply department, oversight of case report form (CRF) development in conjunction with our Data Management and Data Programming departments, ongoing safety data review in conjunction with the study physician and compilation of final study report. You will act as the key point of contact between the study sites, study monitor(s) and relevant internal departments; providing regular accurate feedback and information to the clinical trial team, management and internal databases, as requested. In addition, you will contribute to clinical sections of regulatory documents as required (Investigator Brochure, annual safety reports, submission documents), present study data internally, share best practices with colleagues and actively participate in training and mentoring activities.This position would ideally suit an experienced Clinical Research Associate (CRA), Clinical Research Coordinator or Clinical Project Manager; or a highly motivated individual with a scientific background in the relevant therapeutic area (diabetes, metabolism, cardiovascular).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 desirable.Experience Required:1. Gained relevant experience (preferred at least 2 years)in Translational Medicine, Clinical Research or Research Nurse experience (CRO, acadmeic institution, hospital or industry)2. Potential to manage both scientific and operational aspects in a multi-disciplinary organization (teamwork).3. Knowledge of drug development process4. Capable of clear written and verbal expression of ideas; an active/proactive communicator. Novartis Institutes for BioMedical Research is an equal opportunity employer committed to embracing and leveraging diverse backgrounds. M/F/D/V Job ID: 39530BR