Senior Clinical Data Coder
Job Description
The role of the Senior Clinical Data Coder (Sr. CDC) is to manage the performance of clinical data coding activities from database set-up through database lock on assigned projects, commensurate with experience and/or project role. Responsible for managing coding data for a moderate to large study or multiple small size studies and functioning as an SME and Principal CDC, with minimal to no supervision. In addition will provide leadership, project organization and training as SME to less experienced members of the coding team.
All tasks should be performed in accordance to corporate quality standards, SOPs/Work Instruction/Guidelines, ICH-GCP and/or other international regulatory requirements.
Accountabilities:
? Manage all phases of coding data management activities from study start up to database close, which may include:
? Conduct medical coding.
? Development of database build specifications related to coding.
? Development of data validation specifications related to coding.
?… Test data creation & User Acceptance Testing.
? Performing/ leading functional QC activities and testing.
? Input into Coding Guidelines/conventions including SOP revision as needed.
? Coding validation and cleaning.
? Perform early and final database QC activities.
? Database lock activities
? Maintaining Clinical Study Documents and archiving as appropriate.
? Responsible for completeness, timely delivery and quality of clinical data.
? Lead and coordinate other team members within the assigned studies.
? Mentor project team members and be a subject matter expert when needed.
? Represent Data Management (DM) function in external client meetings and presentations as required. May represent PAREXEL at professional meetings / conferences.
Skills
? Excellent interpersonal, verbal and written communication skills
? Excellent technical skills including but not limited to the knowledge of Clinical Trial/Data Management/ Coding Systems, PMED, MS-Office products.
? Sound awareness of all relevant regulations, including ICH-GCP, 21 CFR 11
? Advanced knowledge of medical terminology and coding dictionaries (e.g.MedDRA & WHODrug)
Education
Bachelor?s degree and / or other medical qualification or relevant Coding or Data Management experience
Location: Office Based- Bengaluru/Hyderabad/Chandigarh /Mohali
Minimum Work Experience
Must be able to demonstrate proficiency with all tasks from data start-up through data-base lock. Previous relevant coding, data management work experience required; clinical and/ or research experience with solid understanding of clinical trials methodology and terminology required.
All tasks should be performed in accordance to corporate quality standards, SOPs/Work Instruction/Guidelines, ICH-GCP and/or other international regulatory requirements.
Accountabilities:
? Manage all phases of coding data management activities from study start up to database close, which may include:
? Conduct medical coding.
? Development of database build specifications related to coding.
? Development of data validation specifications related to coding.
?… Test data creation & User Acceptance Testing.
? Performing/ leading functional QC activities and testing.
? Input into Coding Guidelines/conventions including SOP revision as needed.
? Coding validation and cleaning.
? Perform early and final database QC activities.
? Database lock activities
? Maintaining Clinical Study Documents and archiving as appropriate.
? Responsible for completeness, timely delivery and quality of clinical data.
? Lead and coordinate other team members within the assigned studies.
? Mentor project team members and be a subject matter expert when needed.
? Represent Data Management (DM) function in external client meetings and presentations as required. May represent PAREXEL at professional meetings / conferences.
Skills
? Excellent interpersonal, verbal and written communication skills
? Excellent technical skills including but not limited to the knowledge of Clinical Trial/Data Management/ Coding Systems, PMED, MS-Office products.
? Sound awareness of all relevant regulations, including ICH-GCP, 21 CFR 11
? Advanced knowledge of medical terminology and coding dictionaries (e.g.MedDRA & WHODrug)
Education
Bachelor?s degree and / or other medical qualification or relevant Coding or Data Management experience
Location: Office Based- Bengaluru/Hyderabad/Chandigarh /Mohali
Minimum Work Experience
Must be able to demonstrate proficiency with all tasks from data start-up through data-base lock. Previous relevant coding, data management work experience required; clinical and/ or research experience with solid understanding of clinical trials methodology and terminology required.
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