Data Standards Analyst

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.QualificationsSkills

• Leading global virtual teams around technology integration and data standards

• Proven ability to manage independently competing priorities with attention to detail

• Experience in technical project management

• Ability to work effectively with and motivate virtual teams within different cultural

environments

• Ability to negotiate and influence in order to achieve results

• Technical and data standard experience

• Experience writing scripts or parsing XML (including XML schema)

• Knowledge and practical understanding of data standards in a clinical trial environment,

specifically CDISC models (ODM (Operational Data Model), SDTM (Study Data

Tabulation Model), CDASH (Clinical Data Acquisition Standards Harmonization),

Define.xml, etc.)

• Experience in clinical trial systems (such as EDC (Electronic Data Capture), ePRO

(electronic Patient Reported Outcome), IXRS (Interactive Voice and Web Response

System), or CTMS (Clinical Trial Management System))

• Demonstrated ability to learn new systems and function in an evolving technical

environment

• Business process

• Good understanding and experience of clinical trial processes

• Experience in business process redesign and process improvement

• Knowledge of regulatory requirements such as 21 CFR Part 11, and ICH-GCP

• Presentation skills

• Excellent verbal and written communication skills (also in English).

• Strong customer focus (internal and external).

• General skills

• Commitment to quality and quality management

• Ability to adapt to changes in scope and organization

• Sense of urgency

Minimum Work Experience

• 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 – preferablyEEO 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.