of Biotechnology (DBT), Ministry of Science & Technology,
Government of India launched CDSA on 28 September 2009 as an
extramural unit of Translational Health Science & Technology
Institute (THSTI). In order to ensure that the cost of the end
public health clinical products is kept low, it is imperative that
the cost of clinical trials is kept low without compromising on
the quality of the clinical research in developing the products.
In this endeavor, CDSA will strive to maintain a lean team of
clinical, medical, product development, regulatory and biometric
experts liaising with a network of collaborating partners and
institutions to provide customized support.
roles & responsibilities of Medical Monitor (MM) are as
follows but not limited to:
of single and or grouped adverse events, serious adverse events,
drug effect and attribution of causality, and disease condition
training, and mentoring research teams in safety monitoring and
on-site medical monitoring visit and communicate the observations
through detailed visit report
sponsor in preparation of expedited and periodic reports
of clinical narrative reports describing the event and support in
in development of CRF, statistical analysis plan (SAP), DMC
charter and other documents as required by the study.
in study management team meetings, DMC and technical review
meetings, as required.
with investigative sites, address protocol/medical questions in
consultation with sponsor medical monitor
review of data generated by data listings or statistical
medical coding of safety data
individual data with SAEs and potentially clinically important
laboratory test or vital sign abnormalities.
qualification and work experience:
or Postgraduate diploma from recognized university with 2 years
of R&D experience OR
or Allied medical degree from recognized University with 5 years
R&D experience OR
from recognized University with 7 years of R&D experience
with relevant experience in medical affairs and/ or medical
monitoring of research projects will be preferred
experience of working on Vaccine projects and / or regulatory
studies will be an advantage.
more information please check the Link