Jobs · Information Technology · Massachusetts

Software Integrations Lead

Xtalks · Wellesley, MA · 3 wk ago
Information TechnologyFull-time

Preferred location: US East.

Key Accountabilities

  • Primary client engagement contact for integration projects.
  • Lead client meetings and requirements discussions with support from the Integrations Analyst.
  • Maintain knowledge of Prancer RTSM/Admin and serve as the subject‑matter expert, ensuring integration design is compatible with Prancer study design.
  • Log, track, and drive resolution of functional and technical issues discovered during implementation and prior to go‑live.
  • Ensure adherence to required deliverables and milestones as defined in applicable SOPs/WIs.
  • Drive project activities, including study testing and user acceptance testing (UAT).

Requirements

  • Minimum 3 years of experience in the clinical research field, specifically in clinical supplies operations, RTSM/IRT services delivery, and eClinical systems and integrations implementation; or over 7 years of relevant system implementation experience in a related industry.
  • Software implementation and testing experience in clinical research or a supply‑chain‑related industry.
  • Project management experience leading cross‑functional business and technical teams.
  • Knowledge of US FDA Good Clinical Practice (GCP) and ICH GCP regulations, Electronic Records/Electronic Signatures regulation (21 CFR Part 11), and EU Annex 11 (preferred).

Education and Certification

The candidate must possess at minimum a bachelor's degree in a life‑science, supply‑chain management, or information‑technology field, or equivalent experience.

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