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.