eClinical Project Leader - I
Covance
Reading, United Kingdom
1d ago

Job Overview :

Complete eClinical projects per the requirements of the department and stakeholders, and with direction from Department management.

Responsible for the design of RAVE databases via creation of CRF and edit check specifications based upon the study protocol and standards.

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 and Quality Review

  • 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 Chiltern 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 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

    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, EDC and other eTechnologies, preferably RAVE

    Experience :

    Project planning or project management skills

    Multi-lingual skills a plus, fluent English required

    Proven communication skills

    Presentation skills

    Ability to learn the fundamentals of effectively running Department projects, and demonstrate the capability to run project 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

    Experience in writing CRF Specifications and Edit Check Specifications

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