With over 400 active trials in 5 hub countries, Novartis GDO Trial Management feels privileged to bring together and manage all aspects of clinical trial operations reaching around 50 000 patients worldwide.
We are a proactive learning organization and we place a lot of emphasis on collaboration and individual development. As part of this we are very committed to evaluating the latest digital technologies, always looking 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 our team, our organization and our patients.
We are Novartis. Join us and help us reimagine medicine.
The Global Trial Manager contributes, with appropriate oversight, to all aspects of global clinical trial(s) to deliver study outcomes within schedule, budget, quality/compliance and performance standards. May lead specific aspects of global clinical trial(s). Core member of the Clinical Trial Team. Contributes to operational excellence through process improvement and knowledge sharing
Contributes to all operational trial deliverables, under the oversight of the (Associate) Global Trial Director, according to timelines, budget, operational procedures, quality/compliance and performance standards. Assigned responsibilities can include but are not limited to:
• Development of specific sections of the protocol and related documents;
• Development of study tools, guidelines and training materials;
• Organization and logistics of various trial advisory committees (e.g. Data Monitoring Committee, Steering Committee);
• 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 in their work for the trial; 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;
• Implementing issue resolution plans;
• Acting as point of contact for all site-related issues and procedural questions;
• Interact with relevant line functions including data management, drug supply management, clinical development and Novartis Country Pharma Organizations for operational effectiveness and excellence through collaboration;
• Ensuring proper handling of all study close out activities including but not limited to site close out and final drug accountability;
• Ensuring audit readiness of Trial Master File (TMF) documentation.
2. Resource Management:
• Supports the Global Trial Director with the development, management and tracking of the trial level life cycle budget including forecast, and annual cost targets.
3. Core member of the global cross-functional Clinical Trial Team (CTT); reports study progress and issues/resolution plan at the CTT meeting; writes CTT meeting minutes. Organizes and chairs trial sub teams within the scope of his/her delegated responsibilities. Extended member of the Global Clinical Team (GCT).
4. As member of the CTT, contributes to defining the Data Review Plan; Supports data flow and data cleaning process
5. May contribute to talent development through active participation in onboarding and training activities. May participate in GDO Trial Management initiatives, working groups and support leadership in operational/functional excellence.
6. Responsible for implementation of and compliance to standards (SOPs) and best practices for trial management within assigned clinical trial(s) and within clinical program(s) and Development Unit, including sharing lessons learned.
Please note this position is physically based in East Hanover, New Jersey.
Diversity & Inclusion / EEO
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
EDUCATION: Bachelor degree or equivalent degree is required, with advanced degree preferred. At least one of the degrees in life science/healthcare is preferred.
If Registered Nurse (with
EXPERIENCE: 2+ 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.
• Good Knowledge of ICH/GCP; good knowledge of clinical trial design; understanding of the overall drug development process.
• Basic knowledge of relevant therapeutic areas.
Candidate will be hired commensurate with the level of experience.
Sr Global Trial Manager - minimum of 2 years experience years of experience in clinical development.
Expert Global Trial Manager - minimum of 4 years including start-up, maintenance and close out experience with a minimum of 2 years in global clinical research
Please note this position is physically based in East Hanover, New Jersey.
WHY CONSIDER NOVARTIS?
769 million lives were touched by Novartis medicines in 2020 and, whilst 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 at Novartis!
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.Novartis.com/network