Senior Clinical Data Associate

As a Senior Clinical Data Associate at [Company], you will be responsible for providing data management support and assistance throughout the clinical trial data management process. Your role will involve following Standard Operating Procedures (SOPs) and regulatory directives to ensure the successful completion of assigned projects. Some key responsibilities include: - Supporting the Lead DM as a back-up and/or team member to ensure tasks are performed in a timely manner - Performing data entry for paper-CRF studies and conducting quality control of data entry - Assisting in developing CRF specifications and coordinating the review/feedback from stakeholders - Building clinical databases and conducting database build UAT - Specifying requirements for edit checks and maintaining data management documentation - Training clinical research personnel on study-specific items - Reviewing and querying clinical trial data according to the Data Management Plan - Performing medical coding of medical terms for consistency - Coordinating SAE/AE reconciliation and liaising with third-party vendors - Identifying and troubleshooting operational problems for studies - Reviewing and providing feedback on protocols and reports - Participating in the development and maintenance of SOPs - Ensuring all data management project team members are sufficiently trained - Communicating with study sponsors, vendors, and project teams regarding project issues - Presenting software demonstrations/trainings and may require some travel Qualifications required for this role are: - 5+ years of experience - Bachelors and/or a combination of related experience - Proficiency in Microsoft Office - Ability to handle various clinical research tasks - Excellent organizational and communication skills - Basic knowledge of drug, device, and/or biologic development - Preferred experience in clinical, scientific, or healthcare discipline - Skills in dictionary medical coding, CDISC standards, and therapeutic experience in Oncology and/or Orphan Drug In terms of skills and competencies, you should demonstrate strong knowledge of ICH-GCP, precision oncology SOPs, and regulatory guidance. You should be able to motivate project team members, focus on continuous improvement, resolve project-related problems, work independently and in a team, and exhibit professionalism in interactions with customers and teammates. Please note that any data provided as part of the application process will be handled in accordance with our Privacy Policy. If you require a reasonable accommodation to complete the application process, please contact us at QuestionForHR@precisionmedicinegrp.com. Also, be aware of fraudulent job offers not associated with our company, as we do not extend job offers without prior communication and a formal interview process.,