Clinical Development Services Agency (CDSA) mission is to create, develop, nurture world class clinical product development capacity in India.
CDSA invites applications from high performing professionals with a desire to serve public health needs of the country for the below mentioned administrative position
Post: Medical Coder (Surfactant Study)
Name of the post / Emoluments and Age: Medical Coder (Surfactant Study) (up to Rs. 50,000/- per month consolidated) 12 Months
Age Limit: 25-30 years
Qualifications :
1. Medical degree / Lifesciences equivalent (BDS/BAMS/BHMS/M. Pharma)
2. Accredited residency training program or equivalent clinical experience
3. Fluent in English - verbal and written
4. Computer proficiency (e.g. proficiency Microsoft Office suite) Skill: Effective verbal and written communication skills, effective team player, interpersonal skills, high learnability, very high level of integrity, ability to work amidst demanding timelines
Experience
Minimum of 2 years’ experience of working in Medical Coding/ Terminology at a CRO or Pharmaceutical Company.
Job Profile :
Activities
- Responsible for Medical coding and review of all safety data.
- Responsible for Medical review of all coded terms for right mapping of VT with SOC and LLT, PT, HLGT, HLT.
- Assist data manager in creating, reviewing and processing Data Clarification Forms, quality control and updating clinical databases related to safety for ensuring data validity as per the protocol.
- Assists in review of manual data listing as needed.
- Manage all phases of data management activities from study startup to database close.
- To complete database close / lock / freeze checklists.
- To perform reconciliation of the clinical database against safety data, laboratory data and other third party data as appropriate.
- Review CRF / eCRF data entry conventions.
- Performing day to day clinical data quality control and data processing according to the principles of Good Clinical Practice.
- Preparing interim reports for clinical trial status and participating in data extraction in collaboration with the statistician
- Assists the Medical team in other miscellaneous activities as required.
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Work relations (context – main interfaces – functional report)
* Interfaces with Quality Control Manager, SAS programmers, CDC (Clinical Data Coordinator), Project Management team and CRAs
Critical Deliverables
1.Coding of all Medical terms recorded for AE, SAE and Concomitant medications.
2. Resolving DCFs related to safety and efficacy panels enable data cleaning leading to qualitative database
3. Effective generation, resolution and updation of DCFs
4. Timely reconciliation of Safety data in database
Good understanding of MedDRA, WHODDE, Schedule Y and CDSCO-GCP
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 age limit, qualification, experience and other requirements for the posts are relaxable at the discretion of the competent authority, in case of candidates who are otherwise suitable. Candidates not found suitable for the posts notified, can be offered a lower post on the recommendation of the Selection Committee.
5. Number of positions filled will be as per the Institute’s need and availability of the suitable candidates.
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. The salary is a consolidated sum without any other benefits and it is based on experience, qualifications, skill set, etc. of the candidates.
8. This position is strictly project-based.
9. Interested candidates may please send their current CV with a recent photo and cover letter indicating their motivation for the position applied for (150 words) and three references by e-mail with subject line Application for the post of “Medical Coder” to cdsa_admin@thsti.res.in.
10. Incomplete applications will stand summarily rejected without assigning any reasons.
11. All results will be published on our website and all future communications will be only through email.
12. This position will be placed in CDSA Faridabad office located at NCR Biotech Science Cluster at Faridabad Gurgaon-Expressway, Faridabad.
13. Canvassing in any form will be a disqualification.
Those who have applied earlier need not apply again.
CLINICIAL DEVELOPMENT SERVICES AGENCY
An extra mural unit of Translational Health Science & Technology Institute
(an autonomous institute under the Department of Biotechnology (DBT),
Ministry of Science & Technology, Govt. of India)
NCR Biotech Science Cluster at Gurgaon-Faridabad Expressway, Faridabad.
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