Estimated: $46,000 - $67,000 a year
Job title: SDTM Expert
Duration: 12 months contract
- Represent client and Global Development Operations as a member of Standards Development Organization or Standard Support Groups (e.g. CDISC, PhUSE).
- Ensure compliance with clientLearning Curricula, corporate and GXP requirements.
- Lead and contribute to the development of Clinical Data Standards models (including): CDASH, SDTM, Controlled Terminology, TFLs and questionnaires). Includes periodic assessment of standards content for compliance and industry impacts.
- May lead the assessment, implementation and governance of systems and tools to support on standards.
- Lead the development of project plans; determine risks and recommend contingency plans.
- Lead standards compliance review and works with departments and CROs/strategic service providers to strengthen content and interpretation of client standards.
- Develop strategy for Standards Management technology selection and deployment across Clinical Studies with established client SOPs and Policies, and governance models.
- Oversee Standards delivery life cycle, including deployment strategies, Communications, User training and management.
- Other Adhoc responsibility as assigned.
Job Type: Contract
- 8 hour shift
MUST BE FULLY VACCINATED
Work Location: Remote
201 to 500
$5M to $25M (USD)
"All are very supportive "
Former Employee•Senior Recruiter
Work-life balance Work-life balance at MaxisIT Inc is ,so adjustable in the timings. Pay & benefits My pay and benefits at MaxisIT Inc are on time. Never missed any pay check.
"Small Family managed organization with no vision of their future"
Former Employee•Director of Clinical Services
MaxisIT was a software-focused organization that wanted to become more broadly servicing, but new nothing about the Pharmaceutical R&D process. The software they offered lacks the rigorous validation needed for a regulated industry and should not be considered at all equivalent to the large analysis-based systems like SAS or R. Respect for the many disciplines that are a crucial element of the R&D process (e/g/ biostatistics, data management, regulatory, medical writing, etc.) was also lacking. They just saw dollar signs and were led by them, not heading to the suggestions that capabilities be included in their software that would help these other disciplines complete their daily tasks and then target sales to those disciplines as well as the Pharmaceutical Leaders.
"Nice Place to work"
Former Employee•Implementation Specialist
Will get to learn new things with regards to Work.Nice people , friendly environment , encourage to learn new things, flexible timings, Good benefits .
Former Employee•Software Architect
Through Maxisit i worked as a technology consultant in various companies including Sanofi. The management was very supportive and flexible through out my tenure there.