Posted By - ClinAsia Labs Pvt.Ltd. Keywords - Medical Coder, Medical Coding, Medical Writer. Job Description - Review of data points as per the sponsor recommendations or as per project specifications such as Adverse events, Concomitant medications, indications, Lab data, and Medical history. Review of data coded by medical coders with MedDRA, WHODD, NCI-CTCAE and RTOG * *Preparation of listings for internal review after coding *Reviewing of final Coding report for the Sponsor review and Approval
Medical Writer /Coding -ClinAsia Labs Pvt Ltd
Job Description
Review of data points as per the sponsor recommendations or as per project specifications such as Adverse events, Concomitant medications, indications, Lab data, and Medical history. Review of data coded by medical coders with MedDRA, WHODD, NCI-CTCAE and RTOG
* *Preparation of listings for internal review after coding
*Reviewing of final Coding report for the Sponsor review and Approval
*Reviewing of non codeable terms list at the end of the Study for the Sponsor review and Approval.
*Preparing or updating coding related SOPs.
*Reviewing adverse event terminologies for DSMB submission, interims, FDA audit and reviewing SAS outputs in CSR tables.
*Preparation of coding guidelines as per national/international sponsor requirement and regulatory standards.
*Coordinating managing and storing of coding dictionaries, procuring of new versions and testing and validation activities, supportive documents.
*Analyzing medical record documentation in order to assign proper diagnosis, procedure, and other applicable codes.
*Strong know-how on interpreting CPT/ICD/HCPCS manual coding guidelines.
*Familiar in using ICD-9 (International Classification of Diseases) and CPT for outpatient coding.
*Critically analyze and interpret and assign the correct codes for the descriptions available on various medical procedures and diagnosis and other related medical coding as per the medical policy requirements.
Salary: "best in the industry"
Industry: Pharma, Biotechnology, Clinical Research
Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Role Category: Drug Regulatory Affairs/ Documentation
Role: Documentation/ Medical Writing
Keyskills: Medical Coder, Medical Coding, Medical Writer
Desired Candidate Profile
Education: (UG - MBBS - Medicine) AND (PG - Post Graduation Not Required)
*Review in Validation and Planning
coding section in CDMS.
*Input in UAT specifically for coded term fields in CDMS.
*Work closely with data management team with respect to all coding related issues
*Contribute to medical review on clinical data
*maintain excellent knowledge of medical and therapy terms using appropriate information tools, e.g. electronic/online dictionaries, internet etc
*Contribute to improve the existing coding processes and systems
*Provide protocol and study specific briefing to the CDM/Biostat team.
*Perform QC activities in Data Management as and when required.
Company Profile
ClinAsia Labs Pvt.Ltd
www.clinasia.com/
ClinAsia is a globally integrated eCRO offering Clinical research services that brings Asian advantage and global reach to the table. ClinAsia provides full scale clinical research services like Clinical Trial Management, Clinical Data management, Bio-Statistics,
Medical Writing, Regulatory submissions and Pharmacovigilance to small, medium and large Pharma, Biotechnology companies globally via its completely integrated clinical development infrastructure - that is technology enabled and guarantees efficiency, consistent quality, regulatory compliance, global reach, and certainly the cost arbitrage of low-cost delivery region- - to bring you the most eminent, efficient, responsive, opportune, and cost-effective professionalized services which are hallmarks of the drug development.