eClinical Project Leader - II - RAVE Database Design at Covance

Covance is recruting a RAVE Database Project Manager. Homebased in EMEA.

• Complete eClinical projects as per the requirements of the department and stakeholders, and with direction from Department management.
• Oversee the smooth running of the projects conducted within the team, ensuring that members adhere to the schedules and timetables established by the Sponsor for the conduct and completion of projects
• Independently design of EDC databases via creation of CRF and edit check specifications based upon the study protocol and standards
• Host screen review and edit check review meetings
• Schedule, coordinate and oversight the EDC system User Acceptance Testing and Quality Review
• Take the overall responsibility for the study start up until go live including defining and adhering to study build timelines
• Pro-actively communicate with the Project team and vendors in order to meet or exceed sponsor requirements
• Proactively take an action where required in order to meet the timelines and deliverables.
• Work with the study teams and management advising and informing on the processes to be completed to enable the technology to be implemented
• Encourage interest and build confidence in the systems being used in the study and advise on potential benefits of implementation compatible systems
• Advise management regularly on the status and any potential risks or issues with on-going projects to ensure resolutions in a timely manner including any potential issues with resources
• Manage, document and contribute to the eClinical Solutions budgets and proposals as required
• Manage study finances as appropriate for projects within the eClinical Solutions team including the independent management of the revenue recognition and pro-actively communication of the out of scope tasks
• Organize, prepare and conduct any type of EDC training
• Assist Sponsors with EDC and other eTechnologies adoption and implementation tasks including Vendor Selection, Investigator site selection, and site training
• Mentor and assist other members of the eClinical Solutions team as needed to meet requirements of Covance FSPx contracted activities but also to help advance others in the department
• Continuously research eTechnology systems and developments in the EDC/eTechnology industries
• Organize, prepare and conduct any type of EDC 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
• Perform other duties as required by the department

Education/Qualifications:

• University degree in Computer Science or related IT discipline or other related advanced degree or relevant experience

Experience:

• Previous 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 and understanding of EDC and other eTechnologies
• Experience in business process re-engineering or implementation planning
• Project planning or project management skills
• Proven communication skills
• Ability to train and mentor less-experienced staff
• Ability to manage multiple contacts and relationships at various levels
• Ability to take a lead position on a project
• Ability to train, particularly technical training to different levels of ability
• Self-starter able to work independently and willing to provide original thinking
• Successful team player with good oral and written communication skills
• Pro-active approach to day to day operations
• Multi-lingual skills a plus
• Ability to operate a personal computer; work at a desk for long periods of time
• Ability to work independently from a home office environment