Premier Research International

Contract research organization for clinical development

Data Coordinator

Clinical Research OperationsPosted on Nov 11

Full-timeNo salary listedRemote

About the Job

Requirements

A Bachelor's degree or above is required; a degree in Life Science is preferred.
Two to four years of data management mastery or related clinical research industry experience is required.
Knowledge of at least one Clinical Data Management System, such as Medidata Rave or Calyx EDC, is required.
Fluency in written and spoken English is required.
Strong analytical, investigative, and problem-solving skills are required.
The candidate must be able to learn, navigate, and leverage new systems quickly.
Strong organizational skills, high attention to detail, and a customer-service mindset are required.
The candidate must be able to multitask and balance competing priorities in a fast-paced environment.

Responsibilities

Prepare documentation, including CCGs, Data Management Plans, Data Report Specifications, and External Data Transfer Specifications.
Assist in developing standard test data for testing screens and listings and provide feedback on test results.
Perform user acceptance testing on studies, including testing edit checks.
Assist in maintaining databases and support database updates.
Perform data entry.
Generate reports for data review.
Review CRFs, data listings, and databases to ensure captured data follow the protocol, CCGs, Data Management Plan, and other applicable documentation.
Generate queries to appropriate internal or external personnel, including investigational sites, Clinical Research Associates, and client representatives, to resolve problematic data identified during the data management process.
Review query responses and resolve discrepancies.
Perform external data and/or serious adverse event reconciliation.
Act as a Lead Data Coordinator and/or Safety Reviewer on multiple studies.
Submit documents to the Trial Master File.
Support Trial Master File quality control activities.
Perform database quality control activities.
Perform quality control of study reports and CRF archive files.
Support the Data Scientist and/or Project Manager in reporting financial project statistics and study metrics, updating dashboards, and reporting project status.

Premier Research is looking for a Data Coordinator 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.

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)

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.)
Fluent in English (written and spoken)
Strong analytical, investigative, and problem-solving skills
Proven ability to learn, navigate, and leverage new systems quickly
Exceptional organizational skills, high attention to detail, and a customer-service mindset
Ability to multitask and balance competing priorities in a fast-paced environment

About the Company

Premier Research International

Contract research organization for clinical development

Premier Research provides specialized clinical development services for biotech and specialty pharma, focusing on the therapeutic areas where leading scientists work. It supports end-to-end clinical trials including design, site management, data management, biostatistics, regulatory affairs, and medical writing across 20+ countries with about 1,500 employees. It differentiates itself with deep expertise in select therapeutic areas, strong execution, global reach, close collaboration, patient impact, and flexible working conditions. Its goal is to help biotech and pharma teams bring safe, effective therapies to patients faster through high-quality development and regulatory support.

Company size: 1,001-5,000
Company stage: Acquired
Total funding: $79.2M
Headquarters: Morrisville, NC
Founded: 1989

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