New job Consultant (Medical Monitor)_POD in Haryana
Consultant (Medical Monitor)_POD
Company : Clinical Development Services Agency
Salary : ₹90,000 a month
Location : Haryana
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
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
- 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
- Interpretation of single and or grouped adverse events, serious adverse
- Educating, training, and mentoring research teams in safety monitoring
- Conduct on-site medical monitoring visit and communicate the
- Assist sponsor in preparation of expedited and periodic reports
- Review of clinical narrative reports describing the event and support in
- Participates in development of CRF, statistical analysis plan (SAP), DMC
- Participate in study management team meetings, DMC and technical
- Interact with investigative sites, address protocol/medical questions in
- 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
- 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
- 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
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.
Educational qualification and work experience:
- MD/MS or Postgraduate diploma from recognized university with 2 years of
- MBBS or Allied medical degree from recognized University with 5 years R&D
- BDS from recognized University with 7 years of R&D experience
• Candidate with relevant experience in medical affairs and/ or medical
- 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
- Influencing skills including negotiation and teamwork
- Effective communication skills, the provision of timely and accurate
- Understanding of GCP, regulations and guidelines
- Knowledge of adverse medical event investigation, analysis, and reporting
- 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
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
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”