Data Management Specialist

Frontage Laboratories•Exton, PA

4d•Onsite

About The Position

Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials. This role is responsible for managing data transfers between Frontage and clients and internal reporting from data systems, per company SOPs and relevant regulations and requirements.

Requirements

Bachelor’s degree in the STEM field or equivalent work experience.
At least one year of clinical data management or equivalent work experience.
Good skills with office software such as Word, Excel Formula & Power Query, etc.

Nice To Haves

Knowledge or experience of SQL is a great plus.

Responsibilities

Participate in project meetings to understand study protocol and capture clinical trial data elements that we need to capture in our system, particularly those that will need to be reported internally and transferred to our clients.
Work with LIS Application Specialist to make sure those data elements are setup correctly in the system.
Work with Project Managers and clients to create Data Transfer Agreement (DTA).
Build and maintain data management templates for internal reporting and external transfer.
Create process to generate project-specific export of data from or import data to LIS/LIMS and other systems.
Work with Quality Assurance to make sure data accuracy in reports and data transfer.
Ensure the data transfers are carried out according to the corresponding agreements in a timely manner.
Assist with development of departmental data management procedures and ensure compliance with relevant regulations and requirements (HIPAA, GDPR, GCP, GLP, CAP, CLIA, etc.) in conjunction with QA and laboratory management.
Other tasks as assigned.