GCDS Therapeutic Area Lead

PXL FSP is looking for a Therapeutic Area Lead!

The GCDS TA Lead is a subject matter expert in the area of data standards as it relates to developing clinical data collection tools. The individual may be responsible for coordinating data processes related to new therapeutic areas, which may require them to create standards from scratch rather than work to update or change existing standards.

Minimum FTE Years of Experience

• 8+ years’ work experience, which includes 4 years of data management experience and a minimum 2 years in clinical data standards development; or advanced degree with 6+ years’ work experience of which 2 years need to be in clinical data standards development.
• Advanced knowledge and leading-edge skills in clinical data standards.
• Study Data Tabulation Model (SDTM) expertise
• InForm expertise
• Analysis & Reporting experience
• Program-level clinical and business requirements knowledge
• Communication/presentation skills
• Education/training/facilitation skills
• Must have an innovative spirit, outstanding interpersonal skills, leadership and demonstrated proficiency in the management of multiple projects. Knowledge of clinical data management.

Educational Requirements

B.A. or B.S. degree, preferably in life sciences, computer science, or related discipline