Vacancy for Manager, Project Assistant at THSTI
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.
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.
Manager - Clinical Data Management
Project Code: (01) Zinc as an adjunct for the treatment of very severe disease in infants younger than 2 months
Maximum monthly consolidated emoluments : Upto Rs 90,000/-
Minimum Qualification and 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.
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)
• 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
Project Code: (02) Inter Institutional program on Maternal, Neonatal and infant Sciences - A translational approach to studying Preterm Birth
Maximum monthly consolidated emoluments : Upto Rs 25,000/-
Minimum Qualification and experience : Bachelor’s degree with minimum 2 years’ of relevant experience
• Candidates having Biology as a subject in Standard 12 will be preferred.
• Knowledge of Microsoft Office.
• Proven interpersonal skills and ability to work effectively in a team.
Proficiency in English typing.
• Handling and maintaining file.
• Taking memos, sending and receiving correspondences; preparing note for approval.
• Coordinating meetings, data entry into govt, softwares and other issues related to administration and finance.
GENERAL TERMS & CONDITIONS:
1. These are short term positions 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/written test/skill test.
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 01/01/1980 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 treated as d partmental candidates.
7. Number of positions may vary depending upon the requirement at the time of interview/skill test/written test.
8. Outstation SC/ST/ PwD candidates called for the interview/skill test/ interview will be paid to & fro second class railway fare, as per Govt, of India rules on production of the proof of the same.
9. Positions will be initially based either in the THSTI’s laboratories at Faridabad or at the clinical sites in Gurgaon/ New Delhi.
10. All results will be published on our website and all communications will be only through email.
11. Canvassing in any form will be a disqualification.
Date for walk-in-written test/skill test/ interview : 28th December 2018
Registration time and Venue : 09.30 am -10.30 am THSTI, NCR Biotech Science Cluster, 3rd Milestone, Faridabad - Gurugram 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.
See All Other Jobs in our Database