You will be responsible for the design of RAVE databases via creation of CRF and edit check specifications based upon the study protocol and standards. In this role you will have overall responsibility for the study start up until go live including defining and adhering to study build timelines, hosting screen review and edit check review meetings and organisation of User Acceptance Testing.
The FSPx department is a well-established global team within Covance, employees are based across APAC, Europe and North America. This is a full-time, permanent role, you can work office based from any of our UK or German offices or you can work home based anywhere from the UK or Germany. This is an incredibly exciting time to be joining Covance as we continue to grow and expand.
Job Primary Functions
With periodic guidance from Line Management or experienced colleagues, run projects and ensure that members of the team precisely adhere to the schedules and timetables established by the Sponsor for the conduct and completion of projects.
Communicate effectively with the Project team and eTechnology vendors in order to meet /exceed sponsor requirements. Take action where required in order to meet the timelines and deliverables.
Work with the study teams and management advising and informing on the processes that have to be completed to enable the technology to be implemented. Encourage interest and build confidence in the systems.
Advise management regularly on the status and any potential risks or issues with on-going projects to ensure resolutions in a timely manner.
Understand eClinical Solutions budgets and proposals as required.
Organize, prepare and conduct any type of EDC (RAVE) training including but not limited to Train the Trainer, Site training, Investigator Meetings, and Project Team Training.
Create training material as required per study/project requirements.
Coordinate planning and implementation of contracted activities including contribution to study newsletters, presentations at Investigator Meeting, and site assessments.
University degree in Computer Science or related IT discipline
Minimum 0 — 2 + years’ experience; or an equivalent combination of education and experience to successfully perform the key responsibilities of the job
Experience in a clinical development environment
Experience in, or knowledge and understanding of, Medidata RAVE and other eTechnologies
Project planning or project management skills
Multi-lingual skills a plus
Proven communication skills
Ability to learn the fundamentals of effectively running department projects, and demonstrate the capability to run projects with minimal guidance
Successful team player with good oral and written communication skills
Computer literate and good working knowledge of MS Office
Pro-active approach to day to day operations
PLEASE NOTE CANDIDATES WHO DO NOT FULFIL THE CRITERIA MAY NOT RECEIVE A RESPONSE
NO AGENCIES PLEASE
MORE INFORMATION AVAILABLE ON REQUEST
For a confidential discussion about this opportunity, please phone Kevin Thomas on . To apply, please send your CV to