Clinical Data Standards Manager

Who are we?

We are leading the digital transformation of life sciences, creating hope for millions of patients. We help generate the evidence and insights to help pharmaceutical, biotech, medical device and diagnostics companies, and academic researchers accelerate value, minimize risk, and optimize outcomes. More than one million registered users including customers and partners access the world's most trusted platform for clinical development, commercial, and real-world data.

What is the job?

We are looking for a Clinical Data Standards Manager that will lead the industrialized standardization of historical clinical trial data using industry standards and related processes. You will work collaboratively with all the team leads and will provide high-quality, regulatory-compliant standardized data to improve clinical trials. The Clinical Data Standards Manager will provide technical expertise and documentation for SDTM data standardization activities and will help implement proprietary algorithmic data standardization models.

What skills are we looking for?

Minimum 7 years progressive experience at multiple companies in the pharmaceutical/CRO setting including depth in most of the following:

• Lead and conduct QC of SDTM mapping, annotation and conversion
• Reporting to the Director, Clinical Data Standardization, you will lead the industrialized standardization of historical clinical trial data using industry standards (e.g., SDTM, ADaM) and related processes. Working collaboratively with all the team leads you will provide high-quality, regulatory-compliant standardized data to improve clinical trials.
• SDTM subject matter expert, supporting SDTM programming and regulatory submission-related activities with internal and external teams.
• Maintain SOPs, work instructions and guidance documents related to clinical data standards and SDTM.
• Work with statisticians, data scientists, programmers, and project managers to meet customer engagement delivery timelines.

Nice to Have?

• Experience in Oncology

• Prefer experience with pooled clinical trials data or Integrated analysis (ISS, ISE)

   
  

What is in it for you?

• $125,000 - $140,000
• Bonus
• 401k Match
• Fully comprehensive benefits package