Bring your Passion to Premier!
Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality. We have positioned ourselves right in the middle of the action, targeting unmet needs in Rare Disease and Pediatrics, Analgesia, Neuroscience, Oncology, Dermatology, and Medical Devices.
We're looking for a talented and energetic Data Coordinator to join our team!
Working at Premier Research means being an individual - you will be recognized for what you do and you will truly have an impact in an aspiring, empowering and caring culture where people truly work as one team. You can grow and contribute your expertise with colleagues who are genuinely supportive regardless of location or seniority. Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it!
What you'll be doing:
- Prepares documentation, such as CCGs, Data Management Plan (DMP), Data Report Specifications, External Data Transfer Specifications, etc.
- 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
- Generates reports for data review
- Reviews CRFs, data listings to ensure all data captured follow protocol, CCGs, DMP, etc.
- Generates queries
- Reviews responses to queries and resolves 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
- 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
You'll need this background to be considered:
- 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, DataLabs EDC, etc.)