Veeva Consultant

• Experience with R&D specific IT application systems for Document management, trial management, Data management and/or Pharmacovigilance.

• Experience with data visualization and/or analytics tools and ability to build, program and modify new reports and visualizations.

• Experience with Clinical Trial related systems, e.g. Clinical Trial Management System (CTMS), electronic Trial Master File (eTMF, preferably Veeva Vault), Electronic Data Capture (EDC, preferably Medidata RAVE) and Large-Scale Data Analytics (such as SpotFire, CluePoints, JReview or similar).

• Highly proficient in Information Technology systems, including Microsoft Office suite.

• Proven record of working inside a team with different colleagues in any position, including being in the Lead. Being able to tailor feedback on compliance to different levels in the organization from Assistant roles to executive VP levels and in between.

• Knowledge of statistical methods and being able to apply that to detect outliers in data sets and/or to create thresholds such as Quality Tolerance Limits (QTLs) as required by ICH E6 (GCP) is a strong preference.

• Strong preference for candidates with a Project Management certificate and/or proven experience in project management for R&D related projects.

• Strong analytic skills for large quantities of compliance, risk management and clinical data.

• Strong interest in Pharmaceutical Development, mainly in the clinical research (R&D) aspects of drug development.

• Veeva Vault admin certification is required.

• Experience with Veeva RIM Connectors is preferred.

Requirements:

• Should be able to manage Regulatory information management VEEVA RIM & eTMF Demonstrated practical working experience in both processes (eg.xEVMPD) and utilization of regulatory systems (RIMS, VEEVA).

• Handle Regulatory Affairs business processes Regulatory Information management VEEVA Vault RIM.

• Align with Support Team on current issues and initiate problem management.

• Prepare and update application related documentation (Operational Instructions, User Manuals).

• Processes (eg.xEVMPD) and systems (eg.RIMS, VEEVA) Results-driven and pragmatic approach to work Good organizational skills, self-motivated and proactive Meticulous working style and high attitude to quality.