- Responsible for operational aspects of assigned clinical trial(s) executed by GBS Clinical Trial Services on behalf of Novartis Organizations and under the lead of Trial Lead
- Work with the Clinical Trial Lead, Trial Coordinator and Team to ensure successful trial execution from protocol generation to clinical trial report/manuscript writing.
- Responsible for ongoing and effective collaboration with Sponsor, GBS Line Functions ( medical writ-ing, statistics, data management, monitoring, etc.) and third-party vendors.
- 1. Member of the Clinical Trial Team, support the trial Lead to ensure trial deliverables are met according to timelines, budget, quality standards and operational procedures.
- 2. Work with the Trial Lead on investigators meeting organization and all internal meetings re-lated to the clinical trial execution and operational excellence
- 3. In collaboration with the GBS or Sponsor Medical representative, contribute to the trial data ongoing medical/scientific quality review,
- 4. 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. Develop contingency plans as appropriate.
- 5. Ensure and sign off high quality Monitoring Plans and other study plans and reports.
- 6. Work with GBS Line Functions and partners to identify potential operational 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 and deliverables to the next level if no solution can be achieved
- 7. Work with Trial Lead and trial Coordinator for the development, management and tracking of trial budget (internal and external costs) working closely with the GBS Finance and Spon-sor representative. Accountable for accuracy of trial information in all trial databases and tracking systems. Support the Trial Lead in the preparation and presentation of the trial budget to Sponsor representatives.
- Ensure cost reconciliation after trial completion in appropriate payment systems,
- 8. Work with Drug Supply Management to ensure appropriate planning and of trial medication as well as keep overview of drug availability.
- 9. In collaboration with trial Lead, may contribute to the development of protocol as well as clinical sections of regulatory documents like Investigators Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions, review of clinical trial application packages (as needed).
Salary:INR As per company norms
Role:Clinical Research Manager
Desired Candidate Profile
UG:Any Graduate – Any Specialization, Graduation Not Required
PG:Any Postgraduate – Any Specialization, Post Graduation Not Required
Doctorate:Any Doctorate – Any Specialization, Doctorate Not Required
- Please refer to the Job description above