Sr 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 #
360857
AJE Ref #
576169488
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 supporting, under the leadership of the Clinical Trial Head (CTH), all aspects of clinical trial(s) and program level activities as assigned. br br Major Accountabilities: br br 1. Support CTH in ensuring all trial deliverables are met according to timelines, budget, operational procedures and quality standards. Assigned responsibilities can include development of specific sections of protocol and related documents; development of study tools, guidelines and training materials; management of clinical study material; implementation of issue resolution plan; preparation of clinical outsourcing specifications. br br 2. Responsible for management of Contract Research Organizations (CROs) and ensure adherence to scope of work within timelines and budget. br br 3. Support the development, management and tracking of trial budget working closely with the appropriate partners in OGD. br br 4. Support CTH in managing interactions with Oncology Global Development Operations, and other relevant functions including Drug Supply Management and Novartis local medical organizations. br br 5. Accountable for accuracy of trial information in all trial databases and tracking systems. br br 6. Contribute to the ongoing scientific review of the clinical data and support trial data analysis, reporting and publishing. br br 7. May participate in the organization and logistics of various oversight or Advisory Boards. br br 8. Point of contact for managing/answering questions related to trial procedures and patients eligibility. br br 9. Draft CTT meeting minutes. Participate in International Clinical Team meetings. br br 10. May organize and chair trial sub-teams within the scope of his/her delegated responsibilities. br br 11. Assist with 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 OGD, including sharing lessons learned. 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