Global Trial Manager - Department: Oncology Global Medical Affairs
IQVIA Holdings Inc.
Reading, United Kingdom
Contributes, with appropriate oversight, to all aspects of the assigned 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.
1. Contributes to all operational trial deliverables, under the oversight of the GMA (Associate) Global Trial Director/GMA Global Program 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; 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, and statistical programmer;
• Implementing issue resolution plans;
• Acting as point of contact for all site-related issues and procedural questions;
• Managing interactions with relevant line functions e.g., data management, drug supply management, Global Drug Development (GDD) line functions and Novartis Country Pharma Organizations (CPOs);
• 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.
2. Resource Management: • Supports the GMA Global Program 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); 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).
4. As member of the CTT, contribute to defining the Data Review Plan; participate in data review as specified in the Data Review Plan.
5. Support Medical Review Committee process as directed by Global Group Medical Director. Support GMA Associate Global Trial Director/GMA Global Program Trial Director in overseeing third-party Investigator Initiated Trials (ITTs) and Regional and Locally Sponsored Novartis Trials within disease area. Collaborate with local CPOs and Regions to track study progress, update databases and support budget oversight.
6. Support Management of Managed Access Program as assigned. Support Management of physician request, provide treatment plan guidance, ensure compliance with SAE reporting, and manage drug supply. Awareness of local regulatory requirements.
7. Contribute to the development of clinical sections of regulatory documents like Investigators’ Brochures, safety updates, etc.
8. May contribute to talent development through active participation in onboarding and training activities. May participate in GMA and/or cross-functional initiatives.
9. Responsible for education, implementation and compliance to standards (SOPs) and best practices for trial management within assigned clinical trial(s) including sharing lessons learned.
Education: Advanced degree or equivalent education/degree in life science/healthcare recommended.
Languages: Fluent English
- 2-5 years of experience in clinical research. Experience in global clinical research preferred. 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 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.
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.