A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post : Clinical Scientific Expert-II
Job Description
Clinical Scientific Expert II is responsible for ensuring the collection, review/ reporting of high quality trial data, and study reporting/publishing in compliance with Novartis processes, GCP/ICH and regulatory requirements. In addition, Responsible for ensuring high quality scientific inputs to the clinical development process and support program level activities as assigned.
• In collaboration with Trial Statistician, support development of Reporting and Analysis Planning (RAP) modules in line with program standards.
• Responsible to provide expert support in development of and implementation of relevant data capture tools in collaboration with CSD, GTL and IIS as documented in data handling plan or equivalent document (e.g. CRFs, protocol deviations, questionnaires, diaries, translations, edit checks)
• Responsible for performing expert review of ongoing clinical trial data as outlined in the data handling plan or equivalent, supports GTL to prepare database lock; and performing data reconciliation along the whole trial duration in collaboration with management.
• Collaborate with Medical Lead/BSL to identify any safety trends; and as needed, reports on trial data to safety and clinical boards (e.g. SMT, GCT, and GPT).
• In collaboration with Medical Lead or CSD/CSAD, responsible for final analysis and interpretation of results including the development and drafting of clinical trial reports, publications, and internal/external presentations.
• Provide support for biomarkers planning and or execution
Clinical Scientific Expert II is responsible for ensuring the collection, review/ reporting of high quality trial data, and study reporting/publishing in compliance with Novartis processes, GCP/ICH and regulatory requirements. In addition, Responsible for ensuring high quality scientific inputs to the clinical development process and support program level activities as assigned.
• In collaboration with Trial Statistician, support development of Reporting and Analysis Planning (RAP) modules in line with program standards.
• Responsible to provide expert support in development of and implementation of relevant data capture tools in collaboration with CSD, GTL and IIS as documented in data handling plan or equivalent document (e.g. CRFs, protocol deviations, questionnaires, diaries, translations, edit checks)
• Responsible for performing expert review of ongoing clinical trial data as outlined in the data handling plan or equivalent, supports GTL to prepare database lock; and performing data reconciliation along the whole trial duration in collaboration with management.
• Collaborate with Medical Lead/BSL to identify any safety trends; and as needed, reports on trial data to safety and clinical boards (e.g. SMT, GCT, and GPT).
• In collaboration with Medical Lead or CSD/CSAD, responsible for final analysis and interpretation of results including the development and drafting of clinical trial reports, publications, and internal/external presentations.
• Provide support for biomarkers planning and or execution
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