Senior Clinical Data Associate

As a Senior Clinical Data Associate at our company, you will play a crucial role in providing support and assistance throughout the clinical trial data management process for assigned projects. Your responsibilities will include: - Supporting the Lead DM as a back-up or team member to ensure tasks are performed in a timely manner - Performing data entry for paper-CRF studies when necessary - Conducting quality control of data entry - Providing input into timelines and assessing resource needs for projects - Developing CRF specifications and coordinating feedback from stakeholders - Assisting in building clinical databases and conducting database build UAT - Specifying requirements for various edit check types - Creating, revising, and maintaining data management documentation - Training clinical research personnel on study-specific items - Reviewing and querying clinical trial data as per the Data Management Plan - Performing medical coding of medical terms for consistency - Coordinating SAE/AE reconciliation and liaising with third-party vendors - Troubleshooting operational problems and barriers for studies - Reviewing protocols, Statistical Analysis Plans (SAP), and Clinical Study Reports (CSRs) if required - Participating in the development and maintenance of Standard Operating Procedures (SOPs) - Ensuring training for all data management project team members - Communicating with study sponsors, vendors, and project teams regarding data issues - Presenting software demonstrations/trainings and project meetings - May require travel Qualifications required for this role include: - Minimum 5 years of experience - Bachelors and/or related experience - Proficiency in Microsoft Office - Strong organizational and communication skills - Basic knowledge of drug, device, or biologic development - Preferred experience in a clinical, scientific, or healthcare discipline - Knowledge of medical coding and CDISC standards - Skills in ICH-GCP, Precision Oncology SOPs, and regulatory guidance Competencies expected from you are: - Motivating project team members - Focusing on continuous improvement - Resolving project-related problems efficiently - Demonstrating self-motivation and professionalism Please note that any data provided will be stored according to our Privacy Policy. If you require accommodation during the application process, please contact us at QuestionForHR@precisionmedicinegrp.com.,