Clinical Development Services Agency CDSA
Consultant (Medical Monitor)
Consultant, Monitoring, Evaluation, Policy, Research
Faridabad Haryana
Application Email :

Job Type

Full Time

Closing Date

Aug 07 2021

Description

About the Organization:

Department 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.

Job profile:

The roles & responsibilities of Medical Monitor (MM) are as follows but not limited to:

  • Interpretation of single and or grouped adverse events, serious adverse events, drug effect and attribution of causality, and disease condition

  • Educating, training, and mentoring research teams in safety monitoring and reporting

  • Conduct on-site medical monitoring visit and communicate the observations through detailed visit report

  • Assist sponsor in preparation of expedited and periodic reports

  • Review of clinical narrative reports describing the event and support in finalization

  • Participates in development of CRF, statistical analysis plan (SAP), DMC charter and other documents as required by the study.

  • Participate in study management team meetings, DMC and technical review meetings, as required.

  • Interact with investigative sites, address protocol/medical questions in consultation with sponsor medical monitor

  • Perform review of data generated by data listings or statistical analyses.

  • Review medical coding of safety data

  • Review individual data with SAEs and potentially clinically important laboratory test or vital sign abnormalities.

Educational qualification and work experience:

  • MD/MS or Postgraduate diploma from recognized university with 2 years of R&D experience OR

  • MBBS or Allied medical degree from recognized University with 5 years R&D experience OR

  • BDS from recognized University with 7 years of R&D experience

Desirable work experience:

  • Candidate with relevant experience in medical affairs and/ or medical monitoring of research projects will be preferred

  • Past experience of working on Vaccine projects and / or regulatory studies will be an advantage.

 

How to apply



For more information please check the Link