We offer a full range of consulting, clinical development and commercialisation services from a global network of offices in 46 countries
Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life.
We are a global provider of co...
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Create or review mapping specifications for internal data and/or SDTM.
Generate or review internal data and/or SDTM datasets using internal conversion framework, utilities, and global checks Ensure quality review of all datasets (e.g., Pinnacle 21 compliance checking); ensure datasets are available for stakeholder use (medical review, central monitoring, adaptive design, etc.) and compliant for interim and final database.
Program, or oversee programming of, quality review checks and reports for use by Data Managers and other team.
Responsible for creation of submission-ready SDTM packages for FDA/PMDA or other regulatory authority submissions and keeping abreast in changing regulatory.
Responsible for acquiring and maintaining working knowledge in the various and future evolving data collection tools applied in the clinical trial space such as Medidata Rave, Clinical Data Tools such as LSAF, Pinnacle 21, and in CDISC standards such as SDTM, CDASH, Controlled terminology and xml.
Support the development of standards and drive their implementation within the organization.
Training/Mentoring of flex resources is expected to be done by higher experience level when applicable.
Leading a support team when applicable is expected to be done at the higher experience level.
You are:
Bachelor's degree within a Sciences, Computer Science, Engineering or Statisics related fields.
Miimum 5 years' experience with SDTM and SAS programming.
In depth knowledge of data structures.
Experience working in a highly diverse team within clinical research.
Project management skills.
Highly organized with excellent written and verbal communication.
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