Novartis Clinical Scientifc Expert – II Advanced (masters) degree in life
sciences/healthcare (or clinically relevant degree)/ PharmD is required. PhD or
MD preferable
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
Minimum requirements
• Advanced (masters) degree in life sciences/healthcare (or
clinically relevant degree)/ PharmD is required. PhD or MD preferable. Fluent
English (oral and written)
• >3 years’ experience in 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.
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