Pharma jobs

Expert Clinical Manager
Novartis - India

Job Purpose: (State in one sentence the overall objective of the job) Responsible for supporting, under the leadership of the Clinical Trial Head (CTH), all aspects of clinical trial(s) (Phase II through lifecycle management) and program level activities as assigned. Major Accountabilities (Describe 8-12 main activities ) 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. 2. Responsible for management of Contract Research Organizations (CROs) and ensure adherence to scope of work within timelines and budget. 3. Support the development, management and tracking of trial budget. 4. Support CTH in managing interactions with Novartis local medical organizations, Clinical Development Operations and other relevant functions. 5. Accountable for accuracy of trial information in all trial databases and tracking systems. 6. Contribute to the ongoing scientific review of the clinical data and support trial data analysis, reporting and publishing. 7. May participate in the organization and logistics of various oversight or Advisory Boards. 8. Point of contact for managing/answering questions related to trial procedures and patients’ eligibility. 9. Draft meeting minutes. Participate in international clinical Team meetings. 10. May organize and chair trial sub-teams within the scope of his/her delegated responsibilities. 11. Assist with program level activities (e.g., tracking of brand-related publications, development of clinical sections of regulatory documents like safety updates, responses to Health Authorities questions). 12. Responsible for implementation of best practices and standards for trial management within the Region, including sharing lessons learned. Manage daily operation and complete the task as per require TAT.  Minimum requirements: Master Degree English Relavant Experience in Data Mgr For more info visit at mentioned link