Job
Description
As a Clinical Data Associate II at our company, you will provide data management support and assistance throughout the clinical trial data management process. You will follow SOPs/WIs, regulatory directives, and study-specific plans under direct supervision. Your responsibilities will include: - Supporting the Lead DM as a back-up or team member to ensure continuity, responsiveness, and timely task completion - Performing data entry for paper-CRF studies as required - Conducting quality control of data entry - Developing CRF specifications from the clinical study protocol and coordinating feedback from stakeholders - Assisting in building clinical databases - Conducting database build UAT and maintaining documentation - Specifying requirements for edit check types - Creating, revising, versioning, and maintaining data management documentation - Training clinical research personnel on study-specific CRF, EDC, and project-related items - Reviewing and querying clinical trial data per the Data Management Plan - Running patient and study level status and metric reporting - Performing medical coding of medical terms for logic and consistency - Coordinating SAE/AE reconciliation with third-party vendors - Assisting with SAS programming and quality control of SAS programs - Identifying and troubleshooting operational problems for studies based on metrics data - Reviewing and providing feedback on protocols, SAPs, and CSRs - Participating in SOPs and process documentation development - Communicating with study sponsors, vendors, and project teams - Presenting software demonstrations/trainings and at project meetings - Performing other duties as assigned Qualifications: - Bachelors and/or a combination of related experience - 2+ years experience - Proficiency in Microsoft Office - Ability to handle various clinical research tasks - Excellent organizational and communication skills - Professional use of the English language Preferred Qualifications: - Experience in a clinical, scientific, or healthcare discipline Please note that any data provided as a part of the application will be stored in accordance with our Privacy Policy. If you require a reasonable accommodation to complete the application process, please contact Precision Medicine Group. Also, be cautious of fraudulent job offers as our organization follows a formal interview process before extending any job offer. As a Clinical Data Associate II at our company, you will provide data management support and assistance throughout the clinical trial data management process. You will follow SOPs/WIs, regulatory directives, and study-specific plans under direct supervision. Your responsibilities will include: - Supporting the Lead DM as a back-up or team member to ensure continuity, responsiveness, and timely task completion - Performing data entry for paper-CRF studies as required - Conducting quality control of data entry - Developing CRF specifications from the clinical study protocol and coordinating feedback from stakeholders - Assisting in building clinical databases - Conducting database build UAT and maintaining documentation - Specifying requirements for edit check types - Creating, revising, versioning, and maintaining data management documentation - Training clinical research personnel on study-specific CRF, EDC, and project-related items - Reviewing and querying clinical trial data per the Data Management Plan - Running patient and study level status and metric reporting - Performing medical coding of medical terms for logic and consistency - Coordinating SAE/AE reconciliation with third-party vendors - Assisting with SAS programming and quality control of SAS programs - Identifying and troubleshooting operational problems for studies based on metrics data - Reviewing and providing feedback on protocols, SAPs, and CSRs - Participating in SOPs and process documentation development - Communicating with study sponsors, vendors, and project teams - Presenting software demonstrations/trainings and at project meetings - Performing other duties as assigned Qualifications: - Bachelors and/or a combination of related experience - 2+ years experience - Proficiency in Microsoft Office - Ability to handle various clinical research tasks - Excellent organizational and communication skills - Professional use of the English language Preferred Qualifications: - Experience in a clinical, scientific, or healthcare discipline Please note that any data provided as a part of the application will be stored in accordance with our Privacy Policy. If you require a reasonable accommodation to complete the application process, please contact Precision Medicine Group. Also, be cautious of fraudulent job offers as our organization follows a formal interview process before extending any job offer.
