Data Management Specialist
Frontage Laboratories
Summary
Manage data transfers between Frontage and clients and internal reporting from data systems, per company SOPs and relevant regulations and requirements.
Job description
Roles and 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.
Qualifications and Skills
- 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.
- Knowledge or experience of SQL is a great plus.
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.
- Knowledge or experience of SQL is a great plus.
Benefits
- Health insurance
- Dental insurance
- 401(k) plan
- Disability insurance
- Life insurance
Company overview
Frontage Laboratories is a leading global Contract Research Organization (CRO) established in 2001 and headquartered in Exton, Pennsylvania. As an FDA-registered and inspected pharmaceutical development organization, Frontage provides comprehensive, science-driven services throughout the entire drug discovery and development lifecycle. The company operates 26 state-of-the-art facilities across North America, Europe, and Asia, serving biotechnology and pharmaceutical clients of all sizes. Frontage's integrated service portfolio includes drug discovery, drug metabolism and pharmacokinetics (DMPK), preclinical safety and toxicology, formulation development and manufacturing, analytical and bioanalytical testing, clinical trials, and central laboratory services. With over 1,800 employees worldwide, the company has established itself as a strategic partner in advancing innovative therapies from early discovery through regulatory submissions and commercialization. Frontage's expertise spans small molecules, biologics, cell and gene therapies, and agrochemicals, supported by GLP/GCP-compliant operations and a robust quality assurance framework that enables clients to navigate complex regulatory pathways in the US, EU, China, and other global markets.