Senior Data Coordinator

Data Management Bucharest, B


Position at Premier Research

Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.

We’re looking for an exceptional Senior Data Coordinator to bring your passion to our team. You will be encouraged to grow professionally and personally while enjoying cross-functional partnerships with genuinely supportive colleagues, regardless of location or seniority. Most importantly, you will be using your skills to bring tangible hope to critically ill patients around the world.

At Premier Research, we are science-minded and heart-centered. Join us.

Works with assigned Data Scientist to assist them in all Clinical Data Science related activities from database set-up and document generation to database lock. Data Scientist support may include partial coordination of and communication with the broader Clinical Data Science team (e.g. larger data cleaning teams, cross-functional team members), as assigned. The Senior Data Coordinator may work with the Project Manager (PM) on studies and act as the point of contact for all Clinical Data Science responsibilities when designated as the Lead Data Scientist or Data Scientist back-up during relevant periods. Assists in preparing departmental plans, processing of discrepancies and query generation. Reviews Case Report Forms (CRFs), data listings, and Databases (DBs) to ensure that all captured data follow the rules outlined by the protocol and relevant project plans.Prepares documentation, such as CRF Completion Guidelines (CCGs), Data Management Plan (DMP), Data Report Specifications, Edit Checks Specification, External Data Transfer Specifications, etc., with minimum oversight
  • 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
  • Tracks CRFs
  • Performs data entry
  • Reviews CRFs, data listings to ensure all data captured follow protocol, CCGs, DMP, etc.
  • Generates queries
  • Reviews responses to queries and resolve discrepancies 
  • Performs external data reconciliation
  • Acts as a Lead Data Coordinator on multiple studies
  • Performs document submission to Trial Master File (TMF) 
  • Supports TMF Quality Control (QC) activities; may serve as the primary resource for this activity
  • Performs Database QC activities
  • Performs QC of study reports, eCRF PDF files
  • Supports the Data Scientist and/or PM in reporting financial project stats, study metrics, dashboard updates, project status
  • May act as back-up to Lead Data Scientist as required including activities related to DB set-up
  • Interacts with the Data Scientist and other project team members on a frequent basis and may have direct client interaction
  • Ensures all tasks are coordinated and completed as per study plans and timelines
  • Oversees multiple studies on a portfolio to ensure consistency and efficiency
  • Is involved in training and mentoring of newer DC team members and presents appropriate training sessions
  • Serves as a subject matter expert, e.g. EDC system, specific DC tasks to support the wider DC team, etc.
  • Reviews and contributes to the development and/or update of department standard operating procedures and working guidelines
You'll need
  • Bachelor’s Degree or above (preferably Life Science)
  • Typically requires a minimum of 3 years of Data Science experience or related clinical research industry experience
  • Experience working within at least two Clinical Data Management Systems  (CTMS) and In-depth knowledge of at least one (e.g., Medidata Rave, DataLabs, etc.)
  • Familiar with all phases of a study, e.g., DB set-up, maintenance, lock