Clinical Development Services Agency (CDSA) is an extramural unit of THSTI and has been established as a not-for-profit society to provide cost effective, 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.
CDSA invites applications from high-performing professionals with a desire to serve public health needs of the country for the following positions for sponsored research projects:
Name of the post / Emoluments: SENIOR RESEARCH OFFICER (1 position) Up to Rs. 53,680/- per month (consolidated)
QUALIFICATIONS:
MBBS degree / M.Pharm /M.Sc Nutrition from an accredited Indian University with 2-3 years research or teaching experience (Pediatrics / Obstetrics / Nutrition).
For MD/DNB/Diploma in Pediatrics or Obstetrics & Gynecology one year of research experience is desirable.
SKILLS:
* High level of general computer literacy
* Ability to write research papers for peer-reviewed journals.
* Ability to write proposals to national and international agencies for funding..
* Good administrative and time-management ability to meet deadlines.
* Good communication skills both written and oral
Experience: 2-3 years experience in research for medical graduates / MPharm / MSc Nutrition and one year for PG degree in Pediatrics or Obstetrics & Gynecology
Job profile
* Prepare reports and papers describing the results of the research, both confidential and for publication. Interact positively and professionally with other collaborators and partners within industry/commerce and academia.
* Contribute proactively to the development of external funding applications
* Monitor the trial progress to ensure compliance with and adherence to the project plan and to identify, evaluate and rectify problems.
* Contribute to organizational matters in order to help it run smoothly and to help raise its external research profile.
* Be informed of developments in the field of both technical/specific terms and the wider subject area.
* Participate in development of staff by conducting appraisals and performance reviews and training
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Name of the post / Emoluments: RESEARCH OFFICER (Data Management) (1 position) Up to Rs. 43,489/- per month (consolidated)
QUALIFICATIONS:
A bachelor's degree in science or related area.
SKILLS:
* Knowledge of Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology
* Working experience of clinical database systems such as Oracle Clinical, Clintrial, Medidata Rave.
* Thorough understanding of clinical data management methodology
* Knowledge of clinical database design
* Project coordination
* Familiarity with standard coding dictionaries
* Strong communication skills, both written and verbal
Experience: 2-5 years experience in clinical data management activities
Job Profile:
* Provide Clinical data management support to study project and act as Lead Data Manager on assigned projects
* Develops Data Management Plan (DMP), maintains DMP throughout lifecycle of study project and ensures DMP is followed according to study design and requirements
* Develop database (DB), clinical trial data specifications, edit checks, query logic and data validations
* Ensure data processing activities are performed according to protocol, GCP and SOPs
* Coordinate the archiving of study databases and related documents
* Data reconciliation/Review of discrepancies
* Write and resolve data clarifications
* Quality Check of Database Design, Validation Program, Annotated CRF, Data Extract Views, Laboratory Details, Site and Investigators and Final Data Listings
* Performs other data cleaning and database lock activities as assigned
* Participates in study team meetings as DM representative
GENERAL TERMS & CONDITIONS:
1. All educational professional and technical qualification should be from a recognized Board / University.
2. The experience requirement specified shall 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 other requirements for the post can be relaxed at the discretion of the controlling authority, in case candidates are otherwise well qualified.
5. Interested candidates may please send their current CV in the attached form entitled “Employee Biographical Data Sheet with a cover letter and three references by e-mail to cdsa_admin@thsti.res.in Applications will be accepted up to 15t February 2013.
6. 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. Only shortlisted candidates will be contacted for further discussion.
7. Above mentioned positions do not fall under the Contract Career Path of CDSA and are for sponsored research projects. Appointment will be initially for one year and extendable till the duration of the project based on the performance.
8. The salary is a consolidated sum without any other benefits. Salaries mentioned against each position are indicative and actual salary will be based on experience, qualifications, skill set etc. of the candidates.
9. Positions will be initially based in the CDSA's interim office at Gurgaon and will be shifted to its permanent campus in Faridabad when ready.
10. Number of positions filled will be as per the need and availability of suitable candidates.
11. Canvassing in any form will be a disqualification.
CLINICAL DEVELOPMENT SERVICES AGENCY
An extramural unit of Translational Health Science & Technology Institute
(An autonomous institute of the Department of Biotechnology, Min of Science & Technology, Govt. of India)
470 Udyog Vihar, Phase III, Gurgaon - 122-016
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