Description
- Contract RAVE EDC Implementation Consultant
- Sites in Cambridge, UK and Limburg, Germany
- Roll out; standards & process implementation; cross functional integration
- Establish and embed RAVE as the mainstream EDC company tool
- Advise on future use of advanced RAVE functions
Summary
We have a requirement with a medium sized pharmaceutical company to take responsibility for the implementation of the Medidata RAVE EDC system. The role covers the European Research and Development sites in Cambridge, England and Limburg, Germany. The scope of the project includes the pan-company roll-out, standards implementation, process change and implementation, cross functional integration plus cross-departmental project team leadership.
The Company
A Europe-based Research and Development organisation with modern facilities in Cambridgeshire, England and Limburg, Germany. The company focuses on a range of therapeutic areas where they have an impressive range of products in development. This growing organisation covers all aspects of non-clinical research and clinical trials, plus marketed product support. The company is part of a larger global Pharmaceutical group giving it a worldwide presence. To support the growth the company in investing heavily in technology with the latest initiative being the establishment of a fully integrated company standard EDC solution that meets the company CDISC clinical data standards.
The Role
The company has Medidata's RAVE installed and trialed on limited clinical studies handing the new processes through process deviations. The scope of this role is to manage the establishment and roll-out of the system across the R&D organisation. This will include: Managing process change through the development and establishment of processes and procedures. Provide expertise on cross functional integrations with other systems such as Drug Safety, CTMS, IRT, Lab Management etc. Provide expertise on the set-up and creation of a library of standard modules. Provide guidance and drive the creation of naming convention standards. Provide expertise on the set-up and use of TSDV, SQM modules, j review and other data review tools. Assist with UAT and advise on the future use of advanced RAVE tools and functions.
A cross-departmental team is established which includes external vendors when appropriate. The role will require integration with, and when appropriate, leadership of this team ensuring the buy-in of all stakeholders company wide. The project will require on-site presence in both Cambridge and Limburg.
Benefits
An excellent daily rate is on offer in line with market rates. The primary base can be either in England or Germany with travel between sites and accommodation when away from the primary site being fully funded. The contract is expected to run for 12 to 18 months and commitment to project completion would be required.
Education & Experience
Quite simply we are looking for a senior level Consultant who has handled RAVE EDC implementations before. This will include expertise in the areas outlined above while bringing the experience of good working practices and mistakes to be avoided.
Keywords
Medidata RAVE, Electronic Data Capture, EDC, Clinical Data Management, CDM, Implementation Consultant, Implementation Manager
This is a 12-18 month contract position.