Data Coordinator - DM

Job Description

Premier Research is looking for a Data Coordinator - DM to join our Clinical Data Sciences team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. We are Built by You. Your ideas influence the way we work, and your voice matters here. We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Together, we are Built for Biotech . Join us and build your future here. What youll be doing: Assists in testing of databases (DBs) and maintenance of study data, including the processing of discrepancies and queries. Reviews Case Report Forms (CRFs), data listings, and DBs to ensure that all captured data follow the rules outlined by the protocol, CRF Completion Guidelines (CCGs) and departmental plans. Collaborates cross-functionally with colleagues to ensure the integrity of clinical databases. Prepares documentation, such as CCGs, Data Management Plan (DMP), Data Report Assists in developing standard test data for testing screens and listings and provides feedback on the results of the testing Performs user acceptance testing on studies, including testing of edit checks, etc. Assists in maintaining DBs and supports DB updates Performs data entry Generates reports for data review Reviews CRFs, data listings, and DBs to ensure all data captured follow protocol, CCGs, DMP, etc. Generates queries to appropriate internal or external personnel (e.g., investigational sites, Clinical Research Associates and client representatives) to resolve problematic data identified during various aspects of the data management (DM) process Reviews responses to queries and resolves discrepancies Performs external data and/or serious adverse event reconciliation Acts as a Lead Data Coordinator and/or Safety Reviewer on multiple studies Performs document submission to Trial Master File (TMF) Supports TMF Quality Control (QC) activities Performs database QC activities Performs QC of study reports, CRF archive files Supports the Data Scientist and/or PM in reporting financial project stats, study metrics, dashboard updates, project status What we are looking for: Bachelor s Degree or above (preferably in a Life Science) Typically requires 2 -4 years of DM mastery or related clinical research industry experience Knowledge of at least one Clinical Data Management System (CDMS) (e.g. Medidata Rave, Calyx EDC, etc.)