Rolling Recruitment of Clinical Staff as Manager, Clinical Data Management @ THSTI

Translational Health Science and Technology Institute (THSTI) is an autonomous Institute of the Department of Biotechnology under the Ministry of Science and Technology, Govt. of India. THSTI is developed as a part of the interdisciplinary NCR Biotech Science Cluster to be located at Faridabad, in the National Capital Region. THSTI is designed to be a dynamic, interactive organization with a 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. Permanent laboratories of the centre will come up in Faridabad within one year. The interim laboratories of the centre are functioning from Gurgaon in Haryana.

Post: Manager, Clinical Data Management (1) ( in Pregnancy-infant cohort)

Consolidated Salary: Rs 65,000/- p.m

Qualification & Experience: Bachelor’s degree preferably in field of life science/computer science with at least a diploma in computer applications with 5 to 8 years of data management experience in the health, pharmaceutical or biotechnology industry, out of which 2-3 years of experience as DM Lead or Manager

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

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 detail, accuracy and timelines
* Represent the DM function on project teams
* Write and review DM SOPs in accordance with GCP and ICH guidelines, and develop associated training and competency testing
* Maintain CRFs and database standards
Work in conjunction with Clinical Operations, Clinical Research, and other operations to ensure accurate, efficient, and complete data collection

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

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GENERAL TERMS & CONDITIONS:
1. Appointment will be made on a contract for a maximum period of 1 year at a time with a possibility of extension on satisfactory performance review. There will be an initial probation period of 6 months that may be extended at the discretion of the competent authority.
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. Incomplete applications will stand summarily rejected.
5. In case a large number of applications are received for each post, screening will be done to limit the number of candidates to those possessing higher/relevant qualification or better average in the qualifying exams.
6. All correspondence shall be only through email.
7. Outstation SC/ST 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.
8. Number of positions filled will be as per the need at the time of finalization of selection and availability of the suitable candidates.
9. Reservation rules will be followed as per Govt. of India norms.
10. Canvassing in any form will be a disqualification.

Important dates to remember:
Date of publication of shortlisted candidates: 15^th April, 2014
Date of conduct of Interview: 25^th April, 2014
Date of publication of result: 30^th April, 2014
Last date for joining: 15^th May, 2014