Global Data Standards Manager

Recruiter
Zest Business Group
Location
North Mymms, UK
Salary
Competitive
Posted
17 Sep 2019
Closes
28 Sep 2019
Ref
1259428443
Contract Type
Permanent
Hours
Full Time
Zest Scientific is partnered with a leading pharmaceutical organisation and we currently have an opportunity for a talented Data Manager to join our client's global, multi therapeutic group. There is a competitive package including negotiable salary and bonuses. Responsibilities of the Global Data Standards Manager: Contribute to the design, management and maintenance of biomedical (including clinical trial) data standards from protocol development to regulatory submission Active role in the governance of biomedical data standards Contribute to the curation and integration of data for the creation of data marts Help to maintain content in the Global Data Standards Repository (GDSR) Develop and deploy metrics that assess the usage and value of the biomedical data standards Drive adoption of biomedical data standards from external standards development organizations (SDOs) such as CDISC, HL7, ISO: Identify and propose improvements to processes related to biomedical data standards design, management, maintenance and implementation Provide DSG updates in local forums ( , PDB All Hands, Lunch and Learn sessions, local functional meetings) Who we are looking for: Able to work independently and with other team members cross-functionally to perform impact analyses as part of a change management process, and/or provide support for the implementation of technical projects Must have advanced process-related analytical skills In-depth understanding of clinical trial lifecycle processes required, including but not limited to Protocol Design, Clinical Data Management, Statistical Programming, Statistical Analysis and Electronic Submissions (eSUB) In-depth working knowledge of ADaM In-depth working knowledge of Statistical Analysis Plan components Proven experience of defining data analysis concepts Proven experience of translating statistical analysis requirements into technical specifications In-depth understanding of data collection design vis-à-vis statistical analysis requirements Good understanding of SDTM Good understanding of controlled terminology BS/BA or MS in computer science, mathematics, statistics, or related areas of Clinical Research Experience in pharmaceutical industry, including standards development or implementation within a Biometrics field Experience with CDISC ADaM and other industry standards, possibly including CDISC CDASH, SDTM and/or Controlled Terminology Previous experience as a Study Statistician or Statistical Programmer is a plus Knowledge of a specific therapeutic area or disease area is a plus

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