Contributes, with appropriate oversight, to all aspects of Oncology global clinical trials 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 (CTT). Contribute 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.
Develop specific sections of the protocol and related documents; reviewing related clinical trial documents i.e. Statistical analysis Plan, Tables, Listings and Graphs (TLG)s. Develop study tools, guidelines and training materials.
Lead activities for drug development such as CSR reviews, Narrative writing and database locks. Responsible for the organization and logistics of various trial advisory committees (e.g. Data Monitoring Committee, Steering Committee). As member of the CTT, contribute to defining the Data Review Plan; participate in data review as specified in the Data Review Plan for e.g.
Medical coding, Serious Adverse Event (SAE) reconciliation. Ensure trial information/results are reported within relevant trial repositories and tracking systems (e.g. trial results registries). Support forecast and management of drug supply for Novartis and comparator drug products in collaboration with internal stakeholders. Contribute to development of clinical outsourcing specifications (as required) to facilitate bid process and selection of Contract Research Organizations (CROs). Manage interface with CROs in cooperation with outsourcing management and line functions.
Ensure vendors meet quality standards; contributing to the development/amendment of vendor contracts. Contribute 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. Implement issue resolution plans.
Act as point of contact for all site-related issues and procedural questions. Manage interactions with relevant line functions including data management, drug supply management, clinical development and Novartis Country Pharma Organizations. Ensure 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.
Support the Global Trial Director with the development, management and tracking of the trial level life cycle budget including forecast, and annual cost targets. 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).