Parexel DATA
SURVEILLANCE ANALYST HYDERABAD Educated to a degree level (medical, biological
science, Pharmacy
Job Purpose:
The role will
be part of the Global Clinical Operations, acting as a Data Surveillance Analyst.
The role will perform analysis of specific scientific and operational data to
support the Data Surveillance process and will perform a central review of the
defined project specific Quality Tolerance Limits. The role will support the
specific project functional roles with their DS Plan defined project reviews
and any relevant findings will be communicated to the project team during the
regular project specific Data Surveillance meetings. In addition, the role will
support the development of the Data Surveillance Plan and participate in the
Data Surveillance meetings.
Data
Surveillance Analysts not only need to understand GCP and have a background in
life sciences, but should also demonstrate fluency in statistical, analytical,
and business skill sets in order to interpret risk (both qualitatively and
quantitatively) and strategically support Data Surveillance activities. All
reviews and analysis will be conducted as per the Data Surveillance Plan as
aligned with Data Surveillance related processes, SOPs, ICH and/or other
guidelines to fulfill local regulations.
Maintain a
positive, results orientated work environment, building partnerships and
collaborative relationships, communicating
Skills:
•
Client-centric, quality focused approach to work.
• Ability to
work in a matrix environment and contribute to the overall goals of HPC within
project teams.
• Excellent
verbal and written communication skills, as well as experience in presenting at
internal and sponsor meetings, conveying complex data and information in a
clear, concise manner.
• Demonstrate
basic understanding of SDTM domains and knowledge of data operations concepts.
• Demonstrate
basic SAS programming skills.
• Strong
computer skills including but not limited to the knowledge of a Clinical Trial
Management System (CTMS), Electronic Document Management System (EDMS), and
MS-Office products such as Excel and Word.
•
Demonstrated working knowledge and practical application of functionality of
Parexel and vendor technologies supporting centralized monitoring/data
surveillance and Data Driven Monitoring.
Knowledge and
Experience:
• 5 or more
years of relevant medical, clinical or data management work experience
recommended
• Experience
of working within a DDM study, and/or participating in the Data Surveillance
process highly recommended.
• Basic SAS
programming and/or SQL script writing
Qualifications
Education:
• Educated to
a degree level (medical, biological science, pharmacy or other health related
discipline preferred) or relevant clinical, technology or business equivalent
• Advanced
degree preferred, including MD, PhD, MSc
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