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Overview of the role

You will be the lead data management point of contact for day-to-day activity on a study with key responsibilities for study set-up and close-out tasks, as well as overseeing and coordinating tasks delegated to the study team members both locally and in other offices, reporting to the Data Management Project Manager (DMPM). In addition to this, you would;

· Take part in study kick off (internal and external) meetings along with the DMPM

· Read, ensure understanding and adhere to the study 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

· Assist in compiling the change order log for review by the DMPM

· Assist the DMPM with revenue recognition and revenue forecasting process on a monthly basis

· Lead the development of specifications, implementation, and testing for the eCRF/paper CRF, edit checks, data review and oversight listings (DVS)

· Lead development of the data management plan and study specific procedures

· Ensure effective implementation of standard metric and status reporting on the study

· Perform project planning tasks and support the DMPM in the development of the project plan and timelines

· Be a 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

· Organize and lead regular data management team meetings, both internal and with the sponsor and the DMPM

· Attend and provide an update for data management services at cross-functional study team meeting both internally and with the sponsor and the DMPM

· Support the DMPM in negotiation of time lines and decision making on the study

· Support the DMPM in the delivery of study specific training to all team members, ensuring that the training is documented and the documentation filed in the Data Management Study files

· Provide refresher training to team members as required, and act as mentor to all junior staff levels

· Provide feedback to the DMPM on issues with study team member performance

· Support the DMPM in the delivery of 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)

· Delegate data review, data reconciliation and query management tasks to assigned clinical data coordinators both local and in remote offices

· Review the activity and progress of team members who have been delegated activity

· Bring issues of concern to the attention of the DMPM, including those related to quality, productivity, performance and staff well being

· Travel (approximately 10%) domestic and/or international

Role Requirements

· Bachelor’s degree or local equivalent in a scientific discipline and/or appropriate experience

· In-depth proven and relevant clinical research industry experience

· Experience of at least one of ICON preferred CDMS (Rave, Inform, Oracle Clincal, OCRDC)

· 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 organisational and planning skills as well as a demonstrated aptitude for project management, and the ability to lead more than one project and prioritize accordingly

A better career. A better world. A better you.

Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader.
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