Clinical Data Lead at ICON plc

We have an incredible opportunity for an experienced Clinical Data Lead to join the team.

The role:

•  As a member of staff, the employee is encouraged to accept and supply to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs
•  Travel (approximately 10%) domestic and international
•  Ensure all work performed is of high quality, aligned with Good Clinical Practice, ICH Guidelines and all applicable laws and regulations
•  Independently prepare all materials and take part in study kick off (internal and external) meeting
•  Read, ensure understanding and adhere to the study's protocol, contract and scope of work for all task during set-up, maintenance and close-out of the study
•  Review all activity on an ongoing basis to identify out of scope tasks and bring to the attention of the DMPM and Contract analyst
•  Independently compile the change order log and distribute internally as per ICON's change order process
•  Demonstrate an understanding revenue recognition/forecasting process by performing the process monthly
•  Ensure effective implementation of standard metric and status reporting on study
•  Independently perform project planning tasks and develop the project plan and timelines
•  Set up and maintain data management study files for inclusion in the Trial Master File, ensuring these are maintained in an audit ready state for review by Sponsor, Regulatory or ICON Auditors
•  Adhere to ICON/Client SOPs, the Data Management Plan, Working procedures and study specific procedures in the implementation of tasks on the study
•  Key point of contact for the sponsor and the study team on day to day study data issues, eCRF design, edit checks, and other implemented components
•  Independently attend and provide an update for data management services at cross- functional study team meeting both internally and with the sponsor
•  Maintain and track meeting minutes, issues and decisions logs, and critical issues
•  Independently negotiate the time lines and make study level decisions
•  Provide regular study status updates to the DMPM
•  Support the DMPM in the delivery of study specific training to all team members, ensuring that the training is detailed and the documentation filed in the DM Study files
•  Deliver training to cross-functional study team members both internal and external (e.g. training in the study specific electronic CRF for monitors or Site staff at the investigatory meeting)
•  Represent Data Management at internal/external audits and manage findings through resolution both operationally and within the Quality Management System

You will need:

•  A minimum of 5 years clinical data management experience including 3 years' experience as a data management lead or point of contact for day to day activity on studies with key responsibilities for study set-up and close-out tasks as well as leading all aspects of and coordinating tasks delegated to the study team members
•  Experience of at least one of ICON preferred CDMS (e.g. Rave, Inform, Oracle Clinical, OCRDC, UX EDC)
•  Highly computer literate, including strong Microsoft Office skills (Excel, Word, PowerPoint, Project)
•  Excellent communication and interpersonal skills, both verbal and written skills
•  Strong client relationship management skills and the aptitude to develop this further
•  Excellent organizational and planning skills as well as a demonstrated aptitude for project management, and the ability to lead more than one project and prioritize accordingly