Senior Clinical Data Co-ordinator

5 - 9 years

0 Lacs

Posted:5 days ago| Platform: Shine logo

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Work Mode

On-site

Job Type

Full Time

Job Description

As a Senior Clinical Data Co-ordinator, your role will involve overseeing and co-ordinating tasks assigned to the study team members. You will be responsible for providing training to new data management personnel on processes and procedures, as well as planning, managing, controlling, and performing data processing and management activities for assigned projects in compliance with trial Sponsors requirements. Your key responsibilities will include: - Creating and developing study specifications, implementing and testing eCRF or paper CRF edit checks and data review, overview listings - Authoring and reviewing the Data Management Plan (DMP) - Designing and reviewing case report forms (CRFs/eCRFs) - Participating in the database design process including User Acceptance Testing (UAT) - Reviewing data, issuing and resolving queries, and assisting in resolving medical coding discrepancies - Validating electronically captured data, writing clear queries on missing data and data points failing pre-defined checks - Co-operating with the Quality Assurance Department for quality control audits on assigned databases - Specifying and reviewing database edit check specifications for assigned studies - Leading efforts in developing and maintaining standard database integrity checks - Defining and monitoring clinical trial data flow and quality control processes in accordance with SOPs and guidelines - Providing training to new staff, study site, and sponsor personnel on data management processes and procedures - Maintaining and preparing final archival of data management documentation for assigned clinical trials - Assisting in the recruitment process by conducting interviews and shortlisting candidates Desirable Skills and Experience: - Experience in Clinical Data Management is required Location: Chennai, India Qualification Required: - Bachelors Degree in Pharma Employment Level: - Junior Industry: - Clinical Research Employment Type: - Full Time As a Senior Clinical Data Co-ordinator, your role will involve overseeing and co-ordinating tasks assigned to the study team members. You will be responsible for providing training to new data management personnel on processes and procedures, as well as planning, managing, controlling, and performing data processing and management activities for assigned projects in compliance with trial Sponsors requirements. Your key responsibilities will include: - Creating and developing study specifications, implementing and testing eCRF or paper CRF edit checks and data review, overview listings - Authoring and reviewing the Data Management Plan (DMP) - Designing and reviewing case report forms (CRFs/eCRFs) - Participating in the database design process including User Acceptance Testing (UAT) - Reviewing data, issuing and resolving queries, and assisting in resolving medical coding discrepancies - Validating electronically captured data, writing clear queries on missing data and data points failing pre-defined checks - Co-operating with the Quality Assurance Department for quality control audits on assigned databases - Specifying and reviewing database edit check specifications for assigned studies - Leading efforts in developing and maintaining standard database integrity checks - Defining and monitoring clinical trial data flow and quality control processes in accordance with SOPs and guidelines - Providing training to new staff, study site, and sponsor personnel on data management processes and procedures - Maintaining and preparing final archival of data management documentation for assigned clinical trials - Assisting in the recruitment process by conducting interviews and shortlisting candidates Desirable Skills and Experience: - Experience in Clinical Data Management is required Location: Chennai, India Qualification Required: - Bachelors Degree in Pharma Employment Level: - Junior Industry: - Clinical Research Employment Type: - Full Time

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