Novartis Job For Lifescience – Global Trial Manager Vacancy
Novartis Job For Lifescience – Global Trial Manager Vacancy. Life Science candidates apply online for a Senior Global Trial Manager position that is available at Novartis. Novartis is hiring msc candidates, as per the details below in their Research & Development area:
Job Title: Senior Global Trial Manager
Job ID: 300139BR
Location: Hyderabad, AP
Division: Global Drug Development
Business Unit: GDO GDD
Employment Type: Full-time
Your responsibilities include, however, are not limited to:
- Contributes to all operational trial deliverables, under the oversight of the (Associate) Global Trial Director, according to timelines, budget, operational procedures, as well as quality/ compliance and also performance standards.
- Ensuring trial information/results are reported within pertinent trial repositories and also tracking systems (e.g. trial results registries);.
- Supporting forecast and management of drug supply for Novartis as well as comparator drug products in collaboration with internal stakeholders;
- Contributing to the development of clinical outsourcing specifications (as required) to help with bid procedure as well as the selection of Contract Research Organizations (CROs); managing interface with CROs in cooperation with outsourcing management as well as line functions; ensuring vendors meet quality standards; contributing to the development/amendment of vendor contracts;
- Contributing to the development of Case Report Forms (CRFs), edit checks, CRF completion guidelines, data review reports and also trial statistical analysis plan in collaboration with the trial data manager, trial statistician, statistical programmer and also clinical development representative;
- Managing interactions with relevant line functions consisting of data management, drug supply management, clinical development and also Novartis Country Pharma Organizations;
- Guaranteeing proper handling of all study close out activities consisting of however not limited to a site close out, final drug accountability and also audit readiness of Trial Master File documentation.
- A core member of the global cross-functional Clinical Trial Team (CTT); participate and report study progress as well as issues/resolution plan at the CTT meeting; write CTT meeting minutes. Organize and also chair trial sub-teams within the scope of his/her delegated responsibilities. An extended member of the Global Clinical Team (GCT).
Minimum requirements:
- Advanced degree or equal education/degree in life science/healthcare recommended. Fluent English (oral as well as written).
- 2-4 years of experience in clinical development. Involvement in cross-functional, multicultural and international clinical trials; demonstrated capabilities in supporting operational aspects of clinical trial-related activities.
- Excellent communication, organization and tracking skills.
- Proven ability to work either independently or in a team setting, to meet goals by managing compliance, budget and also timelines.
- Proven networking abilities and capability to share knowledge as well as experience amongst colleagues.
- Knowledge of Good Clinical Practice; comprehensive knowledge of clinical trial design; understanding of the overall drug development process.
- Basic knowledge of the appropriate therapeutic area.
APPLY ONLINE
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