Data Management Specialist
JOB TITLE: Data Management Specialist
DEPARTMENT: Central Lab Services – IT
Full-time
Exton, PA
PURPOSE: Manage data transfers between Frontage and clients and internal reporting from data systems, per company SOPs and relevant regulations and requirements.
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.
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.
Salary and Benefits:
Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance.
Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
Skills Required
- 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
- Knowledge or experience of SQL
What We Do
Frontage Laboratories, Inc. is a CRO that provides integrated, science-driven, product development services throughout the drug discovery and development process to enable pharmaceutical and biotechnology companies to achieve their development goals. Comprehensive services include drug metabolism and pharmacokinetics, analytical testing and formulation development, preclinical and clinical trial material manufacturing, bioanalysis, preclinical safety and toxicology assessment and early phase clinical studies. Frontage has enabled many biotechnology companies and leading pharmaceutical companies of varying sizes to advance a myriad of molecules through development and file regulatory submissions in the United States, China and other countries.
