Ref #: 26739

Employment type: Permanent - Full-Time

Location: UK - Home Based

Posted: 02-May-2021


In this role, you will focus on the setup and troubleshooting of Safety Gateway in RAVE trials, together with responsibility for support in systems inspection readiness and provide expertise as necessary for FDA and other health authority inspections.

This role requires programming skills (C#) and an expert level of RAVE and custom functions.

Your main responsibilities include;

-Reviewing of integration study specifications
-Reviewing study builds in the RAVE EDC system to compare to the integration specifications.
- Testing study integration XMLs to ensure the data flows with no errors into the RAVE EDC system.
- Testing XMLs as needed to update standards.
- Provide training for data integration related activities
- Services rendered will adhere to applicable Johnson & Johnson SOPs, WIs, policies, local regulatory requirements, ICH-GCP, etc. 
- Attending study team meetings as needed.
- Guide study teams in the setup of Safety Gateway
- Review study builds in the RAVE EDC system to compare to the setup Job aids.
- Testing the Safety Gateway setup using our internal Test Automation tool.
- Help implement TA specific request using custom functions

This role requires;

- Bachelor’s degree in engineering, Science, or Computer Science is preferred.
- Minimum of 3 years of experience working within systems covering clinical development in the
Pharma sector.
- Knowledge of Electronic Data Capture (EDC) systems with strong working knowledge of iMedidata and Rave is preferred.
- Strong communication skills
- Attention to detail
- Understanding of GCP, ICH, and 21 CFR part 11
- C# programming and debugging required

If you are seeking the next step in your career, with a competitive salary and benefits package, together with long term development opportunities, please send your CV for review to as soon as possible

#Pharmaceutical #clinicaltrials #datamanagement #projectmanagement #EDC #medidata #rave #goodclinicalpractice #datamanager