Spclst , Technical Product Management

29

Rahway, NJ, USA
Clinical development domain knowledge
Gxp/csv compliance requirements
Cloud environment aws/alicloud
This role owns the end-to-end lifecycle for core clinical development systems including IRT, EDC, and CTMS to support study delivery

Job Summary

  • This role owns the end-to-end lifecycle for core clinical development systems including IRT, EDC, and CTMS to support study delivery.
  • The incumbent ensures stable operations with compliant processes (GxP/CSV) and seamless data integration in cloud environments like AWS or AliCloud.
  • Key responsibilities include defining product vision, managing prioritization trade-offs, and driving user adoption through training and change management.

Matching Summary

This role owns the end-to-end lifecycle for core clinical development systems including IRT, EDC, and CTMS to support study delivery.

Skills & Requirements

Must-have

  • Clinical development domain knowledge
  • GxP/CSV compliance requirements
  • Cloud environment AWS/AliCloud
  • End-to-end system lifecycle management
  • Cross-functional stakeholder collaboration

Nice-to-have

  • CDISC SDTM/ADaM awareness
  • Decentralized trial experience
  • Vendor contract management
  • Statistical analysis literacy
  • Change management expertise

Key Requirements

  • Fluent English communication skills
  • Experience with clinical R&D processes
  • Knowledge of computerized system validation

Work Rights

Not specified

Tailored Resume

Cover Letter