Clinical Data Standards Manager SDTM

Ensure that decisions with respect to SDTM implementation are CDISC-compliant and are in line with industry and regulatory guidance. Preferred Qualifications: • 10 or more years of pharmaceutical/biotech experience in data management, biostatistics or programming.

Client: large biotech 
Job Title: Clinical Data Standards Manager – SDTM
Job Type: W2 Contract
Location: fully remote anywhere in the US
Duration: 1 year + extensions

What you will do
In this role, we are looking for individuals with a strong understanding of end-to-end standards and data flow. Keeping the “end-in-mind” as we partner within the Biomedical Data Stewardship (BMDS) team to ensure the correct data is being collected with our standard protocol and SAP language and data collection standards for analysis and reporting purposes. The position will primarily work within BMDS but may also collaborate with statistical programmers to promote the usage of standards. This role will have an opportunity to work across therapeutic areas to create and maintain clinical trial data standards. This role will also involve supporting a standards data repository with entry and validation of SDTM standards.

In this role you will:
• Build a comprehensive understanding of data standards structure across stages of development
• Build a comprehensive understanding of the Metadata Repository (MDR) product
• Develop mappings between data collection and SDTM standards within MDR
• Develop and maintain guidance documents supporting the analysis and reporting standards
• Ensure that decisions with respect to SDTM implementation are CDISC-compliant and are in line with industry and regulatory guidance
• Provide input to continuously improve the management of analysis and reporting standards and metadata

What we expect of you:
Basic Qualifications:
• Doctoral degree and 4 years clinical trials experience OR
• Master’s degree and 6 years clinical trials experience OR
• Bachelor’s degree and 8 years clinical trials experience
• Proficient in CDISC SDTM modeling, CDISC IGs and TAUGs and regulatory guidance documents
• Effective communication and collaboration skills

Preferred Qualifications:
• 10 or more years of pharmaceutical/biotech experience in data management, biostatistics or programming
• Proven standards development experience
• Experience in designing, analyzing, and reporting clinical trials
• Independent and self-motivated