Clinical Data Associate/Senior Clinical Data Associate

Precision for Medicine is looking for an experienced Clinical Data Associate/Senior Clinical Data Associate to provide comprehensive data management support throughout all phases of the clinical trial data management process. In this role, you will ensure adherence to Standard Operating Procedures (SOPs), regulatory guidelines, and study-specific plans under direct supervision. Your responsibilities will include data cleaning and reconciliations, database testing, quality control, and collaboration within a dynamic team environment. The Clinical Data Associate/Senior Clinical Data Associate will provide data management support and assistance in all aspects of the clinical trial data management process from study start-up to post-database lock for assigned projects. You will follow SOPs/WIs, regulatory directives, study-specific plans, and guidelines. This position may involve database development and testing, as well as additional data management activities. Key responsibilities of the role: - Support the Lead DM as a backup or team member, ensuring continuity, responsiveness, and timely task completion - Perform data entry for paper-CRF studies and ensure quality control of data entry - Provide input into timelines, assess resource needs for projects, and ensure clinical data management deadlines are met with quality - Assist in developing CRF specifications from the clinical study protocol and coordinate review/feedback - Assist in building clinical databases and conduct database build UAT - Specify requirements for edit check types and maintain data management documentation - Train clinical research personnel on study-specific items as needed - Review and query clinical trial data according to the Data Management Plan - Perform medical coding of medical terms for logic and consistency - Assist with coordinating SAE/AE reconciliation and liaising with third-party vendors - Assist with SAS programming and quality control of SAS programs - Identify and troubleshoot operational problems and provide feedback on protocols and reports - Participate in the development and maintenance of SOPs related to data management - Communicate with study sponsors, vendors, and project teams regarding data issues - Present software demonstrations/trainings and participate in project meetings - Perform other assigned duties. Qualifications: - Minimum 4 years of experience in Data Management - Bachelor's degree in a scientific/science field with related experience - Proficiency in Microsoft Office tools - Strong organizational and communication skills - Basic knowledge of drug, device, or biologic development and data management practices Preferred qualifications: - Experience in a clinical, scientific, or healthcare discipline - Medical coding knowledge (MedDRA and WHODrug) - Understanding of CDISC standards - Oncology and/or Orphan Drug therapeutic experience Skills: - Strong knowledge of ICH-GCP, Precision Oncology SOPs, and regulatory guidance Competencies: - Motivates project team members and focuses on continuous improvement - Resolves project-related problems and prioritizes workload effectively - Demonstrates self-motivation and professionalism - Works well independently and in a team environment Precision for Medicine is a precision medicine CRO dedicated to advancing the science of precision medicine across various therapeutic areas. All data provided during the application process will be handled in accordance with the Privacy Policy. Applicants with disabilities requiring accommodations can contact Precision Medicine Group for assistance. Note: Precision for Medicine warns applicants about potential fraudulent offers and emphasizes that all job offers will involve communication with the recruiting team, hiring managers, and a formal interview process.,