Clinical Development Services Agency is an extramural unit of Translational Health Science and Technology Institute and has been established as a not-for-profit society to provide cost affective, high quality preclinical and clinical product development support services to meet the country’s growing healthcare needs. It will tend enterprises; particularly SMEs involved in new technology innovation and facilitate translation of scientific know-how into viable products.
Post : Assistant Data Manager
Project : Sepsis-related mortality in neonates in India : A multi-disciplinary, multi-institutional research program for context-specific solutions
Emoluments (Up to) : Rs. 52080/- per month
Duration : One year (Likely to extend as per the requirement of project)
Location : Faridabad
Job Profile
Responsibilities
• Assist Data Manager in maintenance and update of Data Management
• Assist Data Manager in maintenance and update of Data Management Plan and any other relevant documentations (Edit Checks Document, Annotated CRF, Data Entry Guidelines, Standard Operating Procedures etc.) for ensuring efficient database creation and maintenance
• Should be able to design the paper case report form
• Support Data science team in database development and edit checks implementation
• Assist in creation and enter test data for Clinical Database for screen validation.
• Working knowledge of Query management, data cleaning, data freezing and data archival.
• Interact with other project team members to support the set-up, maintenance, and closure of the Data Management aspects of the project
• Assist Data Manager in preparing interim reports and data extraction
• Working knowledge of database standards and study development process, CDM SOPs, CDISC & SDTM standards
• Should be able to provide training to site data entry operators, if required
• Assist with Data Entry and Reconciliation as needed or assigned
• Assist Data Manager in preparation of datasets for analysis including data cleaning and ensuring compliance with the data protection
• Assist the Data Science team in other miscellaneous activities as required.
Educational Qualifications & Experience
Essential:
• Educated to graduation degree in any field with at least 4 years of experience in clinical data management
OR
• Master’s degree with at least 2 years of experience in clinical data management
Desirable : Diploma in Information Technology / Computer Applications
Skills
• Familiarity with GCP, US-FDA 21 CFR 11, regulatory requirements and data standardization guidelines.
• IT literate (experience with Microsoft based applications and other CDMS applications)
• Must understand clinical trials and familiarity with clinical data management functions.
• Good interpersonal, verbal and written communication skills.
• A flexible attitude with respect to work assignments and new learning.
• Effective time management in order to timelines
• Commitment to project and team goals.
• Must be able to work independently but seek guidance when necessary.
• Sense of urgency in completing assigned tasks
• Must have good team player
• Ability to model behaviors and ethics in line with CDSA Mission and Vision.
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 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. 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.
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 for attending the interview.
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) Candidates are requested to use Google Chrome internet browser for best results in submission of online application.
b. Once online application is submitted, no correction/ modification is possible.
c. In case of difficulty in filling up the online form, please send an e-mail to mahendersingh.cdsa@thsti.res.in.
d. 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.
GENERAL CONDITIONS
The conditions of employment will be the same as that of the project staff on contract basis. The candidates have no right to claim for any regular employment at CDSA. The appointing authority has the right to accept/ reject any application without assigning any reason(s) and no correspondence in this matter will be entertained. However, the selection Committee reserves the right to reduce the experience & Age in case of deserving candidates.
Last date for receipt of online application is 05th December 2021
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