Novartis Clinical Scientific Expert Vacancy – Apply Online
Pharmaceutical Science Jobs. Applications are invited for the post of Clinical Scientific Expert @ Novartis.Career @ Novartis. Pharma job opportunity at Novartis.vacancy at Novartis. Interested candidates may apply online. Check out all the details on Rasayanika.com
Job ID 305781BR
Job Title Clinical Scientific Expert – II
Minimum requirements
• Advanced (masters) degree in healthcare (or clinically relevant degree)/ PharmD is required. PhD or MD preferable. Fluent English (oral and written)
• >3 years’ experience in the Pharmaceutical industry/ clinical research organization
• Advanced knowledge with hands-on experience in planning, executing, reporting and publishing global clinical studies in a pharmaceutical company or contract research organization.
• Strong interpersonal skills. Ability to work under pressure. Excellent negotiation and conflict resolution skills. Collaborates across boundaries for shared success
• Resolve issues with minimal/ no supervision and understands when to escalate
• Thorough knowledge and expertise in Good Clinical Practice, clinical trial design, statistics, regulatory processes, and clinical development process. Strong analytical/computational background
• Demonstrates excellent Medical / scientific writing skills. Demonstrates expert knowledge and application of statistical analysis methodology and can identify trends and analyze/ interpret/ report data effectively.
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 the 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 an 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 with 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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