Like & Share this Job to inform others: Opening for Senior Trial Manager/Trial Lead @ Novartis D2 ift.tt/1zXqV2W Opening for Senior Trial Manager/Trial Lead @ Novartis Job ID - 154337BR Position - Title Senior Trial Manager/Trial Lead Country - India Company/Legal Entity Nov Hltcr Shared Services Ind Functional Area - Research & Development Job Type -Full Time Employment Type - Regular Job Description - Accountable for all operational aspects of assigned clinical trial(s) executed by GBS Clinical Trial Services on behalf of Novartis Organizations. Lead Clinical Trial Teams responsible for full trial execution from protocol generation to clinical trial report/manuscript writing. Accountable for ongoing and effective collaboration with Sponsor, GBS Line Functions ( medical writing, statistics, data management, monitoring, etc.) and third-party vendors. Track performance and quality aspect. 1. Agree with Sponsor team and GBS Line Functions on realistic project and trial timelines. Escalate to higher level in the organization if no agreement can be achieved 2. Accountable for the writing of clinical protocols and related documents (i.e. risk management plan) in collaboration with the GBS or Sponsor Medical representative as appropriate: coordinate the clinical trial protocol development process; contribute to the medical/scientific input given for the development of trial-related documents and processes which reside in other line functions; obtain approval from Sponsor. Collaborate with the Medical Advisors of the major Novartis local medical organizations to ensure country feedback is adequately integrated into protocol (as appropriate). 3. Lead the Clinical Trial Team and assigned Resources to ensure all trial deliverables are met according to timelines, budget, quality standards and operational proce-dures. 4. Accountable for investigators meeting organization and all internal meetings related to the clinical trial execution and operational excellence 5. In collaboration with the GBS or Sponsor Medical representative, lead the clinical trial data ongoing medical/scientific review, final analysis and interpretation in-cluding the development of clinical trial reports, publications and internal/external presentations. 6. Ensure input is provided to clinical outsourcing specifications to facilitate bid templates and selection of vendors (e.g. central lab.). 7. Accountable for project / trial allocation plans within given indications and implementation to ensure optimum patient accessibility, resource utilization / allocation and country. Work closely with the Regional Monitoring Managers on trial feasibility and subsequent patient enrolment. 8. Work with GBS Line Functions and QA to identify potential quality issues and implement actions to resolve them. Work with GBS Clinical Data Sciences team to ensure timely availability of reports / activities needed to track trial performance. Escalate issues endangering data quality to the next level if no solution can be achieved 9. Accountable for the development, management and tracking of trial budget working closely with the GBS Finance and Sponsor representative. Accountable for accuracy of trial information in all trial databases and tracking systems. Responsible for the preparation and presentation of the trial budget (SoW) to Sponsor representatives. 10. Contribute to the development of clinical sections of regulatory documents like Investigators’ Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions and review of clinical trial applications (as needed).Click here for more details and apply
Posted on: Sat, 15 Nov 2014 04:57:31 +0000
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