Improving and expanding the possibilities of Orthopedics, developing next generation of smarter, less invasive, more personalized treatments
Requirements
- Bachelor’s degree (or equivalent) in Statistics, Computer Science or related discipline
- Experience with at least one clinical system (Rave EDC, CTMS, or eTMF ) is preferred
- Medidata Rave EDC Developer Certification preferred
- Experience with CDISC STDM preferred
- Knowledge of GCP and SDLC
Responsibilities
- Work with Data Management leadership to define and document data and process standards
- Create system deliverables for clinical trials
- Support the development and maintenance of global harmonized processes and procedures for system support
- Lead project management activity related to the change control of Interactive Voice/Web Response Systems (IxRS), Electronic Data Capture (EDC) Systems, CTMS, eTMF and other relevant systems for assigned studies
- Interface between Clinical R&D, IT and Quality including CSV regarding clinical systems, UAT, processes and other tools (as needed)
- Assist with the implementation of system and study metrics
Other
- Excellent verbal and written communication skills
- Ability to work in a team environment to deliver critical milestones
- Bachelor’s degree (or equivalent) in Statistics, Computer Science or related discipline
- 4 years of system support in clinical research within Medical Device or Pharmaceuticals
