Senior Clinical Data reputed company
The role of the Senior Clinical Data reputed company (Sr. CDC) is to manage the performance of clinical data coding activities from database set-up through database lock on assigned reputed company, 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 reputed company CDC, with minimal to no supervision. In reputed company will reputed company leadership, project organization and training as SME to less reputed company members of the coding team. reputed company tasks should be performed in accordance to corporate reputed company standards, SOPs/Work Instruction/Guidelines, ICH-GCP and/or other international regulatory requirements. Accountabilities: Manage reputed company phases of coding data management activities from study start up to database reputed company, which may include: Conduct medical coding. Development of database build specifications reputed company to coding. Development of data validation specifications reputed company 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. reputed company early and final database QC activities. Database lock activities Maintaining Clinical Study Documents and archiving as appropriate. Responsible for completeness, reputed company delivery and reputed company of clinical data. reputed company and coordinate other team members reputed company the assigned studies. Mentor project team members and be a subject matter expert reputed company needed. Represent Data Management (DM) function in external reputed company meetings and presentations as required. May represent reputed company at reputed company 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. reputed company awareness of reputed company relevant regulations, including ICH-GCP, 21 CFR 11 Advanced knowledge of medical terminology and coding dictionaries (e.g.MedDRA & WHODrug) Education Bachelors 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 reputed company to demonstrate proficiency with reputed company tasks from data start-up through data-reputed company lock. Previous relevant coding, data management work experience required; clinical and/ or research experience with solid understanding of clinical trials methodology and terminology required. reputed company tasks should be performed in accordance to corporate reputed company standards, SOPs/Work Instruction/Guidelines, ICH-GCP and/or other international regulatory requirements. Accountabilities: Manage reputed company phases of coding data management activities from study start up to database reputed company, which may include: Conduct medical coding. Development of database build specifications reputed company to coding. Development of data validation specifications reputed company 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. reputed company early and final database QC activities. Database lock activities Maintaining Clinical Study Documents and archiving as appropriate. Responsible for completeness, reputed company delivery and reputed company of clinical data. reputed company and coordinate other team members reputed company the assigned studies. Mentor project team members and be a subject matter expert reputed company needed. Represent Data Management (DM) function in external reputed company meetings and presentations as required. May represent reputed company at reputed company 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. reputed company awareness of reputed company relevant regulations, including ICH-GCP, 21 CFR 11 Advanced knowledge of medical terminology and coding dictionaries (e.g.MedDRA & WHODrug) Education Bachelors 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 reputed company to demonstrate proficiency with reputed company tasks from data start-up through data-reputed company 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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