Clinical Scientific Expert - Ii Job in Novartis
Clinical Scientific Expert - Ii
Novartis
4+ weeks ago
- Hyderabad, Telangana
- Not Disclosed
- Full-time
Job Summary
Your responsibilities include, but are not limited to:
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. Lead/ participate in global process improvement work streams or act as Subject Matter Experts for training or SOP.
May support CSD in program level activities where needed including submissions. Participate in the on-boarding, mentoring and training of CSE1 and new hires
Job Description
150! Clinical scientific experts, globally, are part of Global Drug Development (GDD) team, working to ensure clinical trial data and regulatory reports are of highest quality throughout the life cycle of each program, across all disease areas. Be part of a dedicated, passionate team that is diligently providing clinical and scientific inputs at study and program level, thereby supporting Novartis in reimagining medicine for patients worldwide.Your responsibilities include, but are not limited to:
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. Lead/ participate in global process improvement work streams or act as Subject Matter Experts for training or SOP.
May support CSD in program level activities where needed including submissions. Participate in the on-boarding, mentoring and training of CSE1 and new hires
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