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Expert Clinical Manager
| Details |
Country: USA
Location: New Jersey-Northern East Hanover
Total applied: 22 |
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Expert Clinical Manager
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 all operational aspects of 1 or more clinical trial(s) (Phase II through lifecycle management) under the leadership of Clinical Trial Head (CTH) in the Cardiovascular/Metabolism group. Support all scientific aspects of clinical trial(s) as assigned. Responsible for program level activities as assigned. Major accountabilities include the following: Ensure all operational trial deliverables are met according to timelines, budget, operational procedures and quality standards; Provide input and contribute to the development of protocols and related documents, in the ongoing scientific review of clinical data, and in trial data analysis, reporting and publishing; Prepare training materials and presentations related to the planning and conduct of the trial; Prepare clinical outsourcing specifications. Responsible for management of Contract Research Organizations ( CROs) and ensure adherence to scope of work within timelines and budget; Manage interactions with Global Clinical Development Operations and other relevant functions including Drug Supply Management and Novartis local medical organizations; Accountable for accuracy of trial information in all trial databases and tracking systems; Support the development, management and tracking of trial budget working closely with the Therapy Area (TA) program operations group; Participate in the organization and logistics of various oversight and Advisory boards; attend meetings; Point of contact for managing/answering questions related to trial procedures and patients eligibility; Write CTT meeting minutes. May occasionally deputize for the CTH at Clinical Trial Team meetings. Participate in International Clinical Team meetings; Contribute to program level activities (e.g., tracking of CD&MA brand-related publications, development of clinical sections of regulatory documents like Investigators Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions); Responsible for implementation of best practices and standards for trial management within the TA, including sharing lessons learned; Contribute to talent and career development of TA staff through active participation in on-boarding, training and mentoring activities. May serve as faculty member for CD&MA training programs.QualificationsAdvanced degree or equivalent education/degree in life science/healthcare required accompanied with e 2 years experience in clinical research OR" Bachelor degree or equivalent education/degree in life science/healthcare required if accompanied with e 4 years experience in clinical research. 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.
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