Data Coordinator - DM

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.)

Why Choose Premier?

• Premier Research is more than a company – it’s a community furthering research to improve the lives of patients in critical need. We are a diverse staff thinking creatively, challenging ideas, and solving complex problems.

• Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies.

• As a Premier team member, you have the power to make an impact, regardless of job title and location.

• Our dedication to biotech and specialty pharma is unlike any other.

• We provide our staff with innovative technologies and continuous learning.

About Us

Premier Research is a global clinical research, product development, and consulting company. We are dedicated to helping biotech, specialty pharma, and MedTech innovators transform life-changing ideas and breakthrough science into new medical treatments. Our team is inspired by this common purpose. Premier is a place where you can change lives, and feel rewarded and celebrated. We aim high - we will not stop until we reach our goals. And we care about each other, about our customer and partners, and, most importantly, about all the patients that we touch with our work.