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Recruitment for Clinical position at Translational Health Science and Technology Institute

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Translational Health Science and Technology Institute (THSTI) is an autonomous Institute of the Department of Biotechnology, Ministry of Science and Technology, Govt. of India. The institute is an integral part of the interdisciplinary NCR Biotech Science Cluster located at Faridabad, and is designed as a dynamic, interactive organization with the mission to conduct innovative translational research and to develop research collaborations across disciplines and professions to translate concepts into tangible products to improve human health.

This recruitment is to fill up the vacancies of THSTI under the project of PBC & CHME. 

PBC conducts hypothesis driven research on the biological basis of childhood health and diseases. The knowledge generated will be incorporated in THSTI institutional networks in developing diagnostic and therapeutic modalities. The interdisciplinary effort will need to knit together expertise from the fields of pediatrics, infectious disease, microbiology, immunology, cell and molecular biology, systems biology, imaging studies, clinical trials, biostatistics and epidemiology, among others.

Post: Bio-Repository Supervisor, Manager - Clinical Data Management, Data Manager

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Bio - Repository  Supervisor - (01 post)
Project Code:
(03)

Project Name: Creation of a Biorepository and Imaging Data Bank for  Accelerating Evidence Generation to facilitate children to thrive 

Monthly consolidated emoluments: Upto Rs. 50 ,000/-

Qualification & Experience: Post Graduate Degree in Biotechnology from a recognized university. OR Bachelor Degree in Biotechnology from a recognized university with 2 year relevant work experience in clinical research. OR Standard 12 with 5 years relevant work experience

Job Description: Supervise the handling of samples, small equipment at bio repository lab, THSTI and the clinical site and preparation of samples at the clinical site, Should have experience with maintaining compliance with clinical research supervising other research staff and maintaining quality standards

Age Limit (Type of position): 40 years (Study based research  position)

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Manager  – Clinical  Data Management - (01 post)
Project Code: (05)

Project Name: Zinc as an adjunct for the treatment of very severe disease in  infants younger than 2 months

Monthly consolidated emoluments: Upto Rs 90,000/-

Qualification & Experience: Bachelor’s degree preferably in field of life science/computer science with diploma in computer applications with 10 years of data management experience in the health, pharmaceutical or biotechnology industry, out of which at least 5 years of experience as DM Lead or Manager.

Skills:
- Knowledge of GCDM Practices, SAS (Base, Stats, Macro, etc.) and CDISC SDTM/CDASH
- Proficient in Microsoft Office applications, Internet, E-mail etc.
- Proficient with Clinical Data Management Systems(CDMS) and experience with Electronic Data Capture Systems(EDCS)

Job Description:
• Lead / Supervise the DM team
• Create and review (electronic) Case Report Forms as per Protocol and annotated Case Report Forms.
• Develop, review, and maintain a clinical database.
• Develop, document and perform validation of database structure, data capture screens, code lists, edit checks, reports and other functions in EDC (e.g. User Acceptance Testing).
• Develop data transfer agreements and specifications with various vendors.
• Write, review and maintain eCRF completion guidelines, Data Management Plan (DMP), Data Validation Plan (DVP, e.g. edit checks), and other DM related documentation.
• Perform all aspects of DM process as related to processing and QC of the data.
• Clean data for study close out and perform all database lock procedures.
• Monitor study status (e.g. enrolment, CRFs, etc.) and provide status reports to the team.
• Use standard conventions, tools, references and process in support of the coding of medical terms.
• Ensure all DM procedures executed with a high attention to accuracy and timelines.
• Represent the DM function on project teams.
• Write and review DM SOPs in accordance with GCP and ICH guidelines.
• Any other CDM task assigned by project coordinator

Age Limit (Type of position): 45 years (Study based research position)

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Data Manager - (01 post)
Project Code: (01)

Project Name: “ Inter Institutional program for Maternal, Neonatal and infant Sciences – A translational approach to studying Preterm Birth”

Monthly consolidated emoluments: Upto Rs 65000/ -

Qualification & Experience: Bachelor’s degree preferably in field of life science/computer science with diploma in computer applications with 5 years of data management experience in the health, pharmaceutical or biotechnology industry, out of which at least 2 years of experience as DM Lead or Manager.

Skills:
- Knowledge of GCDM Practices, SAS (Base, Stats, Macro, etc.) and CDISC SDTM/CDASH
- Proficient in Microsoft Office applications, Internet, E - mail etc.
- Proficient with Clinical Data Management Systems (CDMS) and experience with Electronic Data Capture Systems (EDCS)

Job Description:
• Create and review (electronic) Case Report Forms per Protocol and annotated Case Report Forms.
• Develop, review, and maintain a clinical database.
• Develop, document and perform validation of database structure, data capture screens, code lists, edit checks, reports and other functions in EDC (e.g. User Acceptance Testing).
• Develop data transfer agreements and specifications with various vendors.
• Write, review and maintain eCRF completion guidelines, Data Management Plan (DMP), Data Validation Plan (DVP, e.g. edit checks), and other DM related documentation.
• Perform all aspects of DM process as related to processing and QC of the data.
• Clean data for study close out and perform all database lock procedures.
• Monitor study status (e.g. enrolment, CRFs, etc.) and provide status reports to the team.
• Use standard conventions, tools, references and process in support of the coding of medical terms.
• Ensures all DM procedures executed with a high attention to ensure, accuracy and timelines.
• Represent the DM function on project teams.
• Write and review DM SOPs in accordance with GCP and ICH guidelines.

Age Limit (Type of position): 45 years (Study  based  research  position)

Interested candidates fulfilling the criteria as mentioned in paragraph, may walk - in for  interview as per the schedule mentioned below:

Walk in  Interview:
Bio - Repository Supervisor
Date and Registration time for walk in interview: 5th April 2016 (Tuesday) (10.00 am-11.00 am)

Venue:
Civil hospital, Jharsa Road, Opposite Municipal Committee, Gurgaon Post Office, Near Bus Stand Gurgaon - 122001 (Candidates should report at Conference Room, Ground Floor, Civil hospital, Gurgaon)

Data Manager, Clinical Data Management
Date and Registration time for walk in interview: 6th April 2016 (Wednesday) (09.30 am  – 10.30 am)

Venue: THSTI,  NCR  Biotech  Science  Cluster,  3rd Milestone, Faridabad  –Gurgaon  Expressway, Faridabad  - 121001

NOTE:  The  candidates  must  bring  their  latest  resume,  one  set  of  photocopy  of  documents  in  support  of  their  educational  qualification  and  experience  along  with  originals  and  a  valid  ID  card  for  verification. Candidates  coming  after  the  time  slot  mentioned will not be entertained.

GENERAL TERMS & CONDITIONS:
1. The se are short term position s and extension will be granted subject to satisfactory performance of the incumbents. Those appointed to these positions will not have any claim for regularization of their employment.
2. All educational, professional and technical qualification should be from a recognized Board/University.
3. The experience requirement specified shall be experience acquired after obtaining the minimum educational qualifications required for the post.
4. Persons working in Govt. /PSUs /autonomous bodies should apply through proper channel or produce a relevant ‘No Objection Certificate’ at the time of Interview.
5. The age limit, qualification, experience and other requirements may be relaxed at the discretion of the competent authority, in case of candidates who are otherwise suitable . In case candidates are not found suitable for the posts notified, they can be offered lower post /lower emoluments on the recommendation of the Selection Committee.
6. Age and other relaxations for direct recruits and departmental candidates: 1. By 5 years for candidates belonging to SC/ST communities. 2. By 3 years for candidates belonging to OBC communities. 3. For Persons with Disabilities (PwD) falling under the following categories : (i) UR - 10 years , ii) OBC - 13 years (iii) SC/ST - 15 years 4. For Ex - servicemen upto the extent of service rendered in defence forces (Army, Navy & Air force) plus 3 years provided they have put in a minimum of 6 months attested service. 5. Relaxation of 5 years will also be permissible to those who had ordinarily been domiciled in the Kashmir division of the State of Jammu and Kashmir during the period from 01/0111980 to 31 /12/1989 subject to production of relevant certificate from concerned authority.6. Age is relaxable for Government servants up to 5 years in accordance with the instructions or orders issued by the Central Government, from time to time 7. There is no upper age limit for the Institute employees who are treate d as departmental candidates.
7. Number of positions may vary depending upon the requirement at the time of interview.
8. Reservation/ Relaxation rules will apply as per Govt. of India provisions.
9. Outstation SC/ST/ PwD candidates called for the interview will be paid to & fro second class railway fare, as per Govt. of India rules on production of the proof of the same.
10. Positions will be initially based either in the THSTI’s laboratories at Faridabad or at the clinical sites in Gurgaon/ New Delhi.
11. All results wil l be published on our website and all communications will be only through email.
12. Canvassing in any form will be a disqualification.

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