Job ID 220206BR
Position
Title Clinical Scientific Expert I
Division Global Drug Development
Business
Unit Global Develop NPH
Country India
Work
Location Hyderabad
Company/Legal
Entity Novartis
Healthcare Shared Services India
Functional
Area Research & Development
Job Type Full Time
Employment
Type Regular
Job Description
Responsibility for ensuring high quality clinical
trial data review as directed by the Clinical Trial Team (CTT):
ü
Perform high quality clinical
data review supporting Interim Analysis and Database Lock activities and
facilitate resolution of clinical data issues. Collaborate with relevant line
functions to advance quality data review with an emphasis on subject safety and
eligibility, data integrity, trend identification, analysis and remediation,
and identification of cases for medical review.
ü
May contribute to the
development of the Data Review Plan (DRP) and data review strategy, ensuring
that protocol-level deviations, eligibility criteria, study assessments &
other aspects of the protocol are implemented consistently across the study.
ü
In conjunction with the
relevant line functions, contribute to Case Report Form (CRF) development, and
support the implementation of data capture tools.
ü
Contribute to and facilitate
data review process improvements e.g. identification of delinquent/redundant
reports and/or implementation of innovative data analysis processes and tools.
ü
Collaborate with relevant line
functions on the development of study-level documents, including clinical
sections of key regulatory documents. In collaboration with relevant line
functions, review/write clinical trial documents for study Clinical Trial
Authorization (CTA), CSR activities, and publications.
ü
May support pharmacovigilance
activities (e.g., reviewing/contributing to aggregate reports/patient
narratives, attendance of Safety Monitoring Meetings (SMT)), if required.
ü
Produce training materials and
provide training to CTT.
ü Support/present at study level meetings (Investigator
Meetings, Data Monitoring Committee (DMC) meetings or others), as required.
Minimum requirements
ü Advanced degree in life sciences/healthcare (or
clinically relevant degree) is required. Pharm D, PhD or MD preferable.
ü Fluent English (oral and written) 1-2 years scientific,
strategic and operational experience in planning, executing, reporting and
publishing clinical studies in industry or Academia, or 3-4 years in Clinical
Operations/Clinical Scientific role
ü Intermediate knowledge of planning, executing, reporting
and publishing global clinical studies in a pharmaceutical company or contract
research organization or similar experience with an academic research
institution
ü Good knowledge of Good Clinical Practice and drug
development processes Strong scientific knowledge in at least one therapeutic
area (e.g., understanding of basic mechanisms of diseases and associated
symptoms, standard of care/treatment, scientific endpoints & clinical
outcomes)
ü Knowledge of principles of clinical data collection and
reporting; ability to use systems and tools (e.g., EDC systems, Excel, etc.)
for data collection, analysis and reporting
ü Analytical / computational background; ability to detect
data trends and escalate as appropriate
End date: 20th October, 2017
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