Novartis Hiring Clinical Scientific Expert – II degree in life sciences/healthcare Apply Now
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).
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
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