New job Consultant (Medical Monitor)_POD in Haryana

Consultant (Medical Monitor)_POD

Consultant (Medical Monitor)_POD

Company : Clinical Development Services Agency
Salary : ₹90,000 a month
Location : Haryana

Full Description

CLINICAL DEVELOPMENT SERVICES AGENCY
An extra mural unit of THSTI,

An autonomous organization of Department of Biotechnology
Ministry of Science & Technology, Govt. of India

3rd Floor, THSTI Building, 3rd Milestone, Gurgaon-Faridabad Expressway,
Faridabad – 121001 (Haryana)

Recruitment Notice No. CDS/RN/11/2021

Name of the post
& No.

Consultant (Medical Monitor) (1)

Name of the Study (MM) ((A Phase III, Multicenter, Randomized, Double-blind, Three arm
Placebo controlled Trial to Evaluate the Efficacy and Safety of two vaccines
in Preventing Tuberculosis (TB) in Healthy Household Contacts of Newly
Diagnosed Sputum Positive Pulmonary TB Patients funded by ICMR in Six
States of India )

Age Limit Upto 45 Years

Emoluments Upto Rs. 90,000 per month,

Duration For 2-12 Months

Location CDSA, THSTI, NCR, Biotech Science Cluster, Faridabad

Job profile The roles & responsibilities of Medical Monitor (MM) are as follows but not
limited to:
  • The MM, in consultation with Medical Director and safety oversight

committees, will provide safety review during the execution of the clinical
trial as per the pre-defined and approved safety management plan. This
oversight includes reviewing safety information and providing applicable
recommendations.

  • 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.
  • Participate in all reviews and procedures required for database lock.
  • Provide Study Team with medical expertise during key activities
  • Contribute to, draft and / or edit Clinical Study Reports (CSR)
  • Assist in development of scientific meeting abstracts and presentations as
well as manuscripts
  • Any other assignment with Clinical Portfolio Management team, based on

project deliverables or exigencies.



GENERAL TERMS & CONDITIONS:

1. All educational professional and technical qualification should be from a

recognized Board/ University and full-time.

2. The experience requirement specified should be experience acquired after

obtaining the minimum educational qualifications required for the post.

3. Persons working in Govt. or Public Sector undertaking should produce “No

Objection Certificate” at the time of Interview.

4. The qualification, experience and the number of position and other

requirements for the post can be relaxed at the discretion of the controlling

authority, in case candidates are otherwise well qualified.

5. Only shortlisted candidates will be contacted for further discussion

6. Incomplete applications will stand summarily rejected without assigning any

reasons.

7. The salary is a consolidated sum as per sanctioned order without any other

benefits. Salary mentioned against the position is an actual and will be based

on experience, qualifications, skill set, etc. of the candidates.

8. The annual premium costs of insurance policies bought by CDSA for the
employees will be deducted from his /her salary. The Subscription of CDSA
insurance policy is mandatory.

9. This position is strictly project-based and hired only for 2-12 months.

10. All results will be published on our website and all future communications will
be only through email.

11. Candidates (Including SC/ST and other backward classes) are not entitled for
the travel reimbursement or any other reimbursement.

12. This position will be placed in CDSA Faridabad office at NCR Biotech Science
Cluster at Faridabad Gurgaon Expressway, Faridabad.

Qualifications and
Experience

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.

Skills • Ability to gain trust and confidence with stakeholders.

  • Operational skills including focus and commitment to quality management
and problem solving
  • Influencing skills including negotiation and teamwork
  • Effective communication skills, the provision of timely and accurate
information to stakeholders
  • Understanding of GCP, regulations and guidelines
  • Knowledge of adverse medical event investigation, analysis, and reporting
procedures and standards
  • Fair and ethical. Creates a culture that fosters high standard of ethics.
  • Basic business computer skills (MS Word, Excel, e-mail)

13. Canvassing in any form will be a disqualification.
14. Submission of application will be thru online mode only otherwise it

will get rejected or ignored.
15. Interested candidates may contact Dr Manjula Singh, Scientist-E at

ICMR singhmanjula.hq@icmr.gov.in


Procedure for filling online application:

a. Before filling up the online application, keep the following documents handy:

i) A soft copy of your passport size photo and signature. (only jpeg/jpg format,

file size 50 kb maximum)

ii) A comprehensive CV (PDF format only, file size 1 mb maximum) containing

details of qualification, positions held, professional experience/distinctions etc.

iii) Candidates are requested to use Google Chrome internet browser for best

results in submission of online application.

a. Once online application is submitted, no correction/ modification is possible.

b. In case of difficulty in filling up the online form, please send an e-mail to

mahendersingh.cdsa@thsti.res.in

c. Those who have applied once need not to apply again.

d. Only technical queries will be resolved (if any), other than

technical will not be entertained.

e. On successful submission of your application, an auto-generated email

containing a reference number will be sent to the email address provided.

Please keep a note of the reference number for future correspondence

Note: This is a rolling out advertisement on CDSA website only. The application

will be screened on weekly basis. In case a suitable candidate is not found, the

call for application will remain open till suitable candidate is found. As soon as

suitable candidate is found, this recruitment notice will be closed on our website.

“Government strives to have a work force which reflects gender balance

and women candidates are encouraged to apply”


Apply Now