Life Science graduates for Clinical Scientifc Expert @ NOVARTIS "P"

Job Title: Clinical Scientifc Expert - I
Job ID: 139053BR
Job Description:
The Clinical Scientific Expert I 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 (under supervision) 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.
• Support 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)
• Performing the ongoing review of 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

1. Qualification: M.Sc. Life Science
2. Experience: 1-2 years

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