Data Standards Analyst 3/25/2020


Waltham, MA
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Mid-Career (2 - 15 years)
Bachelors Degree


Global Data Operations (GDO) provides clinical data services for PAREXEL s Clinical Research
Services (CRS) business unit. Services include Biostatistics, Data Management, Clinical Database
Programming, Statistical Analysis and Reporting, and related Data Operations support during the
execution of a sponsor s clinical trial.
The Data Standards Analyst (DSA) is the subject matter expert for PAREXEL, industry and sponsor
specific data standards supporting all functional groups of GDO. The primary role of the DSA is to
work hand in hand with the Clinical Database Programmer (CDBP) and Data Management Lead
(DML) during the set-up phase of a given project. The DSA participates on data standards process and
technology projects. In addition, the DSA may act as a consultant for data standards on bid defense
meetings and new projects. They will also support downstream activities that relate directly to the data
standards implemented such as Clinical Data Interchange Standards Consortium (CDISC) standards
mapping.QualificationsMinimum Work Experience:

- 5 7 years of experience in the minimum experience as a Data Management Lead and/or as a Programmer
- Operational experience required in Data Management and/or Clinical Database Programming roles
- Experience with clinical database concepts and programming.
- Experience in areas of eClinical Technology or Information Technology project management7
years professional experience
- Experience with external data standards organization (CDISC, HL7)Education:
Bachelor s degree preferably around life sciences and/or computer sciences - and / or
equivalent experience.

Operational and administrative responsibilities:

- Maintain a working knowledge and ensure compliance with applicable ICH-GCP Guidelines, local
regulatory requirements and PAREXEL WSOP and study specific procedures
- Complete routine administrative tasks in a timely manner (e.g. timesheets, metrics, travel expense

EEO DisclaimerParexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.