May 31, 2022

Job Description

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).

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

• 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 Novartis?
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Global Drug Development
Hyderabad, AP
Research & Development
Full Time
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Senior Global Trial Manager

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