Position Summary:
The lead data management point of contact for day to day activityon a study with key responsibilities for study set-up and close-out tasks aswell as overseeing and coordinating tasks delegated to the study team membersboth locally and in other offices, reporting to the Data Management ProjectManager.
Job Responsibilities
Recognize, exemplify and adhere to ICON's values whichcenters around our commitment to People, Clients and Performance
As a member of staff, the employee is expected to embrace andcontribute to our culture of process improvement with a focus on streamliningour processes adding value to our business and meeting client needs
Travel approximately 10% domestic/international
Read, ensure understanding and adhere to all assigned ICON SOPsand working procedures
Ensure all work performed is of high quality, compliant with GoodClinical Practice, ICH Guidelines and all applicable laws and regulations
Complete all assigned training (including the Study LeadDevelopment Program) and courses in the ICON Training Management system(iLearn); ensuring that mandatory courses are all completed before thedesignated date and that the required system specific training has beencompleted for current studies
Record all billable and non-billable time in the appropriatetimesheet management system (e.g. PlanviewTM)
Take part in study kick off (internal and external) meeting alongwith the DMPM
Read, ensure understanding and adhere to the study protocol,contract and scope of work for all task during set-up, maintenance andclose-out of the study
Review all activity on an ongoing basis to identify out of scopetasks and bring to the attention of the DMPM and Contract analyst
Assist in compiling the change order log for review by the DMPM
Develop an understanding of the revenue recognition and revenueforecasting process
Assist the DMPM with revenue recognition and revenue forecastingprocess on a monthly basis
Lead the development of specifications, implementation, andtesting for the eCRF or paper CRF
Lead the development of specifications, implementation, andtesting for the edit checks and data review and oversight listings (DVS)
Lead development of the data management plan and study specificprocedures
Ensure effective implementation of standard metric and statusreporting on the study
Lead development of specifications for custom reporting on thestudy
Perform project planning tasks and support the DMPM in thedevelopment of the project plan and timelines
Set up and maintain data management study files for inclusion inthe Trial Master File, ensuring these are maintained in an audit ready statefor review by Sponsor, Regulatory or ICON Auditors
Adhere to ICON SOPs, the Data Management Plan and study specificprocedures in the implementation of tasks on the study
Adhere to the project plan and timelines in the implementation ofstudy tasks during set-up, maintenance and close-out of the study
Key point of contact for the sponsor and the study team on day today study data issues, eCRF design, edit checks, and other implementedcomponents
Organize and lead regular data management team meetings, bothinternal and with the sponsor and the DMPM
Attend and provide an update for data management services atcross-functional study team meeting both internally and with the sponsor andthe DMPM
Maintain and track meeting minutes, issues and decisionslogs, and escalations
Support the DMPM in negotiation of time lines and decision makingon the study
Provide regular study status update to the DMPM
Support the DMPM in the delivery of study specific training to allteam members, ensuring that the training is documented and the documentationfiled in the Data Management Study files
Assess the training needs of study team members on an ongoingbasis
Provide refresher training to team members as required
Provide feedback to the DMPM on issues with study team memberperformance
Support the DMPM in the delivery of training to cross-functionalstudy team members both internal and external (e.g. training in the studyspecific electronic CRF for Monitors or Site staff at the investigatorymeeting)
Job Requirements:
To perform this job successfully, an individual must be able toperform each essential duty satisfactorily. The requirements listed below arerepresentative of the knowledge, skill, and/or ability required. Reasonableaccommodations may be made to enable individuals with disabilities to performthe essential functions.
US/LATAM/CAN: A minimum of 3 years clinical data managementexperience.
EU/APAC: Prior relevant clinical research industryexperience.
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 andwritten skills
Strong client relationship management skills, and the aptitude todevelop this further
Excellent organizational and planning skills as well as ademonstrated aptitude for project management, and the ability to lead more thanone project and prioritize accordingly
Bachelor's degree or local equivalent in a scientific disciplineand/or appropriate experience

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