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 : 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. 69440/- per month
Duration : One year (Likely to extend as per the requirement of project)
Location : Faridabad
Job Profile
Responsibilities
• Clinical Study Protocol understanding and experience in the preparation of Data Management documents - DMP (Data Management Plan), DVP (Data Validation Plan/ Edit Checks Document), Annotated CRF, Data Entry Guideline etc.
• Quality Check of Database Design, Validation Program, Annotated CRF, Data Extract Views, Laboratory Details, Site and Investigators and Final Data Listings
• Good experience and working knowledge of CRF designing
• Preparation of Data transfer guidelines for external data load and self-evident correction chart.
• Working knowledge of Query management, data cleaning, data freezing and data archival.
• Change Requests and takes approval from sponsor
• Global library review and approval for changes
• Interact with other project team members to support the set-up, maintenance, and closure of the Data Management aspects of the project
• Sound knowledge of Clinical Database Development tools, logics and techniques and GCDMP
• Working knowledge of database standards and study development process, CDM SOPs, CDISC & SDTM standards
• AE/SAE reconciliation
• Knowledge of medical dictionaries integration and medical coding in the databases
• Prepare interim reports and review of listings of data for clinical trial status and data extraction in collaboration with the statistician
• Prepare DM status reports for internal monitoring and data science teams
• Maintaining and archiving of clinical study related documents
• Participates in cross functional team meetings & external client meetings as DM representative
• Generate ad-hoc reports as needed
• The data manager will ensure that security of all data is maintained and confidentiality of participants is protected.
• Knowledge of Laboratory Information Management Systems (LIMS)/ Biorepository Management System to track requisition and specimen status
• Maintain stringent standards for quality, identifying any issues which might adversely impact the quality of test results and immediately communicating these to the appropriate management representatives to ensure prompt resolution
• Effective interaction with intra-departments to ensure all required, vital information and documentation is acquired in a timely manner.
• Lead in preparation of datasets for analysis including data cleaning and ensuring compliance with the data protection.
• Development of Standard Operation Procedures and training to the study team for the implementation of medical coding in the CDMS.
• Supervise study related DM activities at the clinical site.
• Should be able to work under pressure and in multiple studies simultaneously
• Support to Data Science team, as and when required
Educational Qualifications & Experience
• Educated to Graduation degree level in healthcare field, IT, Computer Applications with at least 7 years of experience in clinical data management (Clinical Data Manager / Data Validation Associate/ Data Quality Manager).
OR
• Master’s degree in healthcare field, IT, Computer Applications with at least 5 years of experience in clinical data management (Clinical Data Manager / Data Validation Associate/ Data Quality Manager).
Desirable : Diploma in Clinical research and clinical data management. Familiarity with industry standard CDMS and analytical software
Skills
• Good management & leadership 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 have experience in handling EDC tools
• Validation programming
• Must understand clinical trials and familiarity with clinical data management functions.
• Good interpersonal, verbal and written communication skills.
• Client focused approach to work.
• A flexible attitude with respect to work assignments and new learning.
• Meticulous attention to detail.
• Effective time management in order to meet metrics or team objectives.
• Commitment to project and team goals.
• Must be able to work independently but seek guidance when necessary.
• Team player with outstanding inter-personal, negotiation skills and organizational skills.
• Sense of urgency in completing assigned tasks
• Exhibits a sense of urgency about solving problems and completing work.
• Shows commitment to and performs consistently high-quality work.
• 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. A 10% annual increase in salary is based on the performance. 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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