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 here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
Your ideas influence the way we work, and your voice matters here.
As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Join us and build your future here.
This is a hybrid role based out of our Bangalore office
What You will 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
- 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.)
