Senior Global Trial Manager
- Hyderabad, India
With over 400 active trials in 5 hub countries, Novartis GDO Trial Management is committed to delivering end-to-end support to make the clinical trial process more efficient and patient-friendly. We bring together and manage all aspects of clinical trial operations to meet milestones in terms of quality, cost, and delivery time in order to better serve our patients. We develop strategies to optimally deploy resources as well as manage performance, budgets, and contractors. TM is a proactive learning organization focused on collaboration and individual development to foster a synergistic environment. We rise to meet the challenges of the future by utilizing the latest digital technologies and data while optimizing risk to transform trials and improve lives. TM is in search of those who are passionate about applying their experience to reimagine clinical trial operations and ultimately improve the lives of patients.
Your responsibilities include, but 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, and quality /compliance and performance standards.
• Ensuring trial information/results are reported within relevant trial repositories and tracking systems (e.g. trial results registries);
• Supporting forecast and management of drug supply for Novartis and comparator drug products in collaboration with internal stakeholders;
• Contributing to development of clinical outsourcing specifications (as required) to facilitate bid process and selection of Contract Research Organizations (CROs); managing interface with CROs in cooperation with outsourcing management and 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 trial statistical analysis plan in collaboration with the trial data manager, trial statistician, statistical programmer and clinical development representative;
• Managing interactions with relevant line functions including data management, drug supply management, clinical development and Novartis Country Pharma Organizations;
• Ensuring proper handling of all study close out activities including but not limited to site close out, final drug accountability and audit readiness of Trial Master File documentation.
• Core member of the global cross-functional Clinical Trial Team (CTT); participate and report study progress and issues/resolution plan at the CTT meeting; write CTT meeting minutes. Organize and chair trial sub teams within the scope of his/her delegated responsibilities. Extended member of the Global Clinical Team (GCT).
• Advanced degree or equivalent education/degree in life science/healthcare recommended. Fluent English (oral and 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 timelines.
• Proven networking skills and ability to share knowledge and experience amongst colleagues.
• Knowledge of Good Clinical Practice; comprehensive knowledge of clinical trial design; understanding of the overall drug development process.
• Basic knowledge of appropriate therapeutic area.
Why consider Novartis?
799 million. That's how many lives our products touch. And while we're proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people's lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you're given opportunities to explore the power of digital and data. Where you're empowered to risk failure by taking smart risks, and where you're surrounded by people who share your determination to tackle the world's toughest medical challenges.
We are Novartis. Join us and help us reimagine medicine.
Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons.
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