GoI CDSA Jobs With Rs. 90,000 pm Salary - Life Sciences Apply

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/16/2019 Title of study

The follow-up study to evaluate the impact of continuous KMC initiated immediately after birth compared to KMC initiated after stabilization in newborns with birth weight 1.0 to <1.8 kg on their neurodevelopmental outcomes in low-resource settings.

Name of the post Quality Manager (Medical) Position 1 position Age Criteria Upto 45 years Emoluments/Duration Rs. 90,000/- per month consolidated, 24 Months of Project Location Safdarjung Hospital, New Delhi and CDSA, THSTI, NCR, Biotech Science Cluster, Faridabad Job profile The roles & responsibilities of Quality Manager are as follows but not limited to: The Quality Manager, in consultation with the Senior Team at CDSA and the Principal Investigator (PI) will conduct data, medical, process monitoring at the trial site, and provide applicable recommendations. This will include:  Manage study operational plan – project timeliness and quality of deliverables.  Develop and maintain GCP/ICH compliant processes which control the quality of work at the trial site  Actively lead or assist activities in the areas of Internal Quality improvements and CAPA (Corrective and Preventive Actions).  Ensure that studies are conducted in accordance with sponsor protocols, GCP guidelines, and regulatory requirements.  Prepare study monitoring plan and related SoPswith respect to patient confidentiality and safety, recruitments, outcome assessment, randomization, allocation, project timeliness and the key risk indicators for quality.  Conduct source document verification and review of case record forms / study performas for assessing the study trends  Conduct process monitoring as per pre-defined and approved extent, frequency and criticality.

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Qualifications and Experience

Skills

Lead or assist with identifying non-conformances with requirements, provide suitable recommendations and facilitate ongoing quality improvements using risk-based methodology.

Proactively identify the project risks and assist in providing training to study staff in good clinical and documentation practices.

Manage and maintain databases for the quality system Prepare and assist in preparing annual reports and quality trending reports.

Assist in development of scientific meeting abstracts, Clinical Study Reports (CSR) and presentations as well as manuscripts Maintain the trial master file and ensure updation on regular basis Participate in study specific trainings, project review meetings Work closely with other study teams 1. Any other assignment with Clinical Portfolio Management team, based on project deliverables or exigencies

Educational qualification and work experience:  MD/MS or Postgraduate diploma from recognized university OR  MBBS / Allied medical degree from recognized University with 5 years R&D/ clinical research experience OR  Masters in Lifesciences and MPH from recognized University with 3 years of R&D/ clinical research experience Desirable work experience:  Relevant experience in quality control/ quality assurance /monitoring of clinical studies  Past experience of working on studies with Pediatric/ neonatal participants Experience of working on longitudinal cohorts will be an advantage  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, email) 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 other requirements for the post can be relaxed at the discretion of the Chairman of the Interview Committee, in case candidates are otherwise well qualified.

5. Only shortlisted candidates will be contacted for interview 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 the maximum and can be lesser based on candidate’s experience, qualifications, skill set, etc.

8. This position is strictly project-based.

9. All results will be published on our website and all future communications will be only through email 10. Candidates (Including SC/ST and other backward classes) are not entitled for the travel reimbursement or any other reimbursement for attending the interview.

11. This position will be placed at Safdarjung Hospital, New Delhi and CDSA, THSTI, NCR, Biotech Science Cluster, Faridabad.

12. Canvassing in any form will be a disqualification.

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) The documents in support of educational qualification and experience (PDF format only, file size 1 mb maximum) as mentioned below:  Matriculation Mark sheet  Intermediate Mark sheet  Graduation Degree/Mark Sheet  Post-Graduation Degree/Mark Sheet  Ph.D degree  Relevant experience certificates

b. c. d. e.

 Caste certificate in the format prescribed by the Govt. of India, if applicable  Disability certificate in the format prescribed by the Govt. of India, if applicable  List of Publications (if any)  List of patents (if any Candidates are requested to use Google Chrome internet browser for best results in submission of online application.

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

In case of difficulty in filling up the online form, please send an e-mail to mahendersingh.cdsa@thsti.res.in On successful submission of your application, a pop up window will appear showing the reference number. Please keep a note of the reference number for future correspondence.

Last date for receipt of online application is 2nd October 2019

“Government strives to have a work force which reflects gender balance and women candidates are encouraged to apply”