CERTARA Scientist, Quality Manager Masters in Pharmacology or
Pharmaceutics (with relevant experience), Pharma D, Clinical Practice, Masters
in Public Health and Epidemiology. PhD in Pharmaceutical sciences, MD Pharmacology
Job Overview:
This role involves interpretation (analyzing and Quality
control) of Clinical trials data across various therapeutic areas and actively
contribute to the development of database products that support informed
decision making at various stages of clinical development and post approval
phases using modelling and simulation approaches. This job necessitates a
profound knowledge of pharmacology and clinical research, understanding of
statistics, experience in development, quality management and change management
process of clinical databases for conducting systematic literature review and
meta-analysis (pair wise, network and model based meta-analysis), knowledge of
Information science, a PICOS based Clinical/Medical literature search
approaches
Responsibilities:
· Play a key role in the development of clinical database
products in various therapeutic areas like Metabolic & CV, Neuroscience,
Autoimmune, Oncology, Respiratory etc., with a very high quality that support
Meta-analysis (Pair wise, Network and Model based meta-analysis)
· Analyze and Review or Quality control the information pertaining
to
o Trial design, treatments, demographics and outcomes data
(biomarker, clinical, safety and quality of life outcomes) for full time course
from clinical literature (Journals, conference abstracts, Regulatory reviews
etc.)
o The data extracted from graphs for outcomes reported on
linear, logarithmic and semi-log scales with precision
· Perform the above consistently with a very high quality,
provide the required feedback and training to the data analysts & reviewers
at L1/L2/L3 continuously thereby contributing to the enhancement of database
quality and ensure reduction of rework
· Involve in pilot and sample database products to evolve and
validate the specifications, develop meta data lists thereby contributing to a
comprehensive processes
· Work in a team environment with lead consultant, peer data
analysts, data reviewers, Team leader and Project Manager and actively
contributing to the database rules, specifications and a comprehensive quality
management system on continuous basis to assure “first time correctness”
· Actively contribute to process implementation, identify
process enhancements and ensure change management necessities
· Review and finalize the queries and special cases raised by
the team to set up appropriate work flows and thereby monitor the change
management process
· Conduct the literature search in multiple data sources
using the search strategies developed by Team leader and cross verify the
synonyms and related terms used as search terms
· Review the literature search results, identify the miss
cases and share the analysis report basing which the PICOS based search
algorithm shall be enhanced (by lead consultant/Team leader/Project Manager) to
include the specific terms resulting in the miss cases
· Work closely with Data analysts and Data reviewers and
train them with specifications, data standards, check lists and recommend right
ontologies for data consistency
· Consolidate the data from reviewers and ensure quality
control by submitting relevant documents like check lists, error logs and
Acceptance or Rejection report to Team leader
· Undergo relevant training programs (Statistics, R coding,
Systematic literature review and Data analysis methods) and excel in these
skill enhancement programs to grow in the organization ladder
Education, Experience, Training, and Knowledge:
Masters in Pharmacology or Pharmaceutics (with relevant
experience), Pharma D, Clinical Practice, Masters in Public Health and
Epidemiology. PhD in Pharmaceutical sciences, MD Pharmacology are eligible with
minimal/no work experience
· Minimum 5-7 years of experience in the areas of Information
science, Systematic Literature review, Health-economics and public health
sectors, pharmaceutical industry experience preferred
· Strong knowledge of Pharmacology and clinical research is a
must
· Knowledge of clinical development and post approval phases,
PICOS approach, trial designs, Pharma Industry data standards/ontologies
· Good Knowledge of statistics, data management tools like R
is an added advantage
Skills & Abilities:
· Comfortable in a team environment and able to communicate
with and collaborate with peer scientists
· Excellent interpersonal skills
· Excellent domain training skills
· Strong learning skills to be able to support databases in
multiple disease areas
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