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.
1. 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; 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;
•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.
•Supports the Global Trial Director with the development, management and tracking of the trial level life cycle budget incl 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.
5May contribute to talent development through active participation in onboarding and training activities. May participate in GDO Trial Management initiatives and working groups.
6.Responsible for education, implementation and compliance to standards (SOPs) and best practices for trial management within assigned clinical trial(s) and within clinical program(s) and franchise, including sharing lessons learned. EEO Statement 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 any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Minimum requirements Advanced degree or equivalent education/degree in life science/healthcare recommended.
•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.