Ex Clinical Manager - Oncology Clinical Development

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POST DATE 9/14/2016
END DATE 10/12/2016

Novartis Oncology East Hanover, NJ

Company
Novartis Oncology
Job Classification
Full Time
Company Ref #
360861
AJE Ref #
576169493
Location
East Hanover, NJ
Experience
Entry Level (0 - 2 years)
Job Type
Regular

JOB DESCRIPTION

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A health care company with global reach. A product pipeline filled to the brim. A team committed to scientific advancement. Think what's possible. Novartis and its associated companies are always looking for talented employees globally. We are engaged in advance preparation for potential position openings. Submit your CV/resume now to join our talent pool for the position described below. Please note that you are not applying for a current vacancy, but are submitting your CV/resume for consideration for future, possible opportunities. We look forward to receiving your information. Job Purpose: br br Responsible for all operational aspects of 1 or more OGD clinical trial(s) under the leadership of Clinical Trial Head (CTH). Support all scientific aspects of clinical trial(s) as assigned. Responsible for program level activities as assigned. br br Major Accountabilities: br br 1. Ensure all operational trial deliverables are met according to timelines, budget, operational procedures and quality standards. br br 2. 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. br br 3. Prepare training materials and presentations related to the planning and conduct of the trial. br br 4. Prepare clinical outsourcing specifications. Responsible for management of Contract Research Organizations (CROs) and ensure adherence to scope of work within timelines and budget. br br 5. Manage interactions with Oncology Development Operations and other relevant functions including Drug Supply Management and Novartis local medical organizations. br br 6. Accountable for accuracy of trial information in all trial databases and tracking systems. br br 7. Support the development, management and tracking of trial budget working closely with the appropriate partners in OGD.. br br 8. Participate in the organization and logistics of various oversight and Advisory boards; attend meetings. br br 9. Point of contact for managing/answering questions related to trial procedures and patients eligibility. br br 10. Write CTT meeting minutes. May occasionally deputize for the CTH at Clinical Trial Team meetings. May participate in International Clinical Team meetings. br br 11. Contribute to program level activities (e.g., tracking of OGD program-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). br br 12. Responsible for implementation of best practices and standards for trial management within the TA, including sharing lessons learned. br br 13. Contribute to talent and career development of OGD staff through active participation in on-boarding, training and mentoring activities. May serve as faculty member for OGD training programs. br br Novartis is an Equal Opportunity Employer. br br b EEO Statement /b br The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. br