Vacancy Filled
Expert Clinical Manager, BU Oncology (m/f)
- Job Reference:
- Ref. No. 79920/11
- Location(s):
- Western Europe
- Position type:
- Full time
- Sector(s):
- Pharmaceutical & Drug Development
- Function(s):
- Project Management
- Date posted:
- 09 June 2008
Key Tasks and Responsibilities:· Responsible for supporting, under the leadership of the Clinical Trial Head (CTH) and Clinical Indication Leader (CIL) and/or Clinical Program Leader (CLP), all aspects of clinical trial(s) (phase I through lifecycle management) and program level activities as assigned. · Responsible for all operational aspects of one or more clinical trials by 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; and implementation of issue resolution plans. · Support CTH in preparation of clinical outsourcing specifications and in the follow-up with day to day operational activities with the contract research organization(s) (CROs) and/or 3rd parties. · Support CTH in managing interactions with Oncology Clinical Development Operations and other relevant functions including Drug Supply Management and Novartis local organizations (CPOs). · Update regularly all trial information databases and tracking systems in order to manage accuracy of information. · Contribute to the ongoing scientific review of the clinical trial data during the course of the trial.· Support CTH in delegated aspects of trial data analysis and reporting. · May assist in program level activities (e.g., tracking of OCD compound publications, development of clinical sections of regulatory documents like investigators' brochures, briefing books, safety updates, IND/NDA submission documents, and responses to health authorities questions).
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