Job ID 214915BR
Position
Title Clinical
Scientific Expert I
Division Global
Drug Development
Business
Unit Global
Develop NPH
Country India
Work
Location Hyderabad
Company/Legal
Entity Nov
Hltcr Shared Services Ind
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):
1. 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.
2. 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.
3. In conjunction with the
relevant line functions, contribute to Case Report Form (CRF) development, and
support the implementation of data capture tools.
4. 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.
5.
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.
6. May support pharmacovigilance
activities (e.g., reviewing/contributing to aggregate reports/patient
narratives, attendance of Safety Monitoring Meetings (SMT)), if required.
7.
Produce training materials and
provide training to CTT.
8. Support/present at study level
meetings (Investigator Meetings, Data Monitoring Committee (DMC) meetings or
others), as required.
Minimum requirements Advanced
degree in life sciences/healthcare (or clinically relevant degree) is required.
Pharm D, PhD or MD preferable. 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 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 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) 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 Analytical / computational background; ability to detect data trends
and escalate as appropriate
End date to apply: 30th June, 2017
For more job updates follow at PHARMACOMPANION
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