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Clinical Data Lead
This is an exciting opportunity to work within a fast paced,busy environment for a leading global provider of outsourced developmentservices to the pharmaceutical, biotechnology and medical deviceindustries. The lead data management point of contact for day to dayactivity on a study with key responsibilities for study set-up and close-outtasks as well as overseeing and coordinating tasks delegated to the study teammembers both locally and in other offices.
Overview of the Role
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 embraceand contribute to our culture of process improvement with a focus onstreamlining our processes adding value to our business and meeting clientneeds.
Travel (approximately 10%) domestic I international.
Read, ensure understanding and adhere to all assigned ICON /ClientSOPs and working procedures.
Ensure all work performed is of high quality, compliant withGood Clinical Practice, ICH Guidelines and all applicable laws and regulations.
Complete all assigned training (including the COLDevelopment 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. Planview?).
Prepare all materials and take part in study kick off(internal and external) meeting along with 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 ofscope tasks and bring to the attention of the DMPM and Contract analyst.
Assist in compiling the change order log for review by DMPM.
Develop an understanding of the revenue recognition and revenueforecasting process by performing revenue recognition and revenue forecastingprocess on a monthly basis with guidance from the DMPM.
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 studyspecific procedures.
Ensure effective implementation of standard metric andstatus reporting on the study.
Lead development of specifications for custom reporting onthe study.
Perform project planning tasks and develop the project planand timelines with guidance from the DMPM.
Set up and maintain data management study files forinclusion in the Trial Master File, ensuring these are maintained in an auditready 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 taskson the study.
Adhere to the project plan and timelines in theimplementation of study tasks during set-up, maintenance and close-out of thestudy.
Key point of contact for the sponsor and the study team onday to day study data issues, eCRF design, edit checks, and other implementedcomponents.
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 atcross- functional study team meeting both internally and with the sponsor withminimal oversight from the DMPM.
Maintain and track meeting minutes, issues and decisionslogs, and escalations.
Support DMPM in negotiation of time lines and decisionmaking on the study.
Provide regular study status updates to the DMPM.
Support the DMPM in the delivery of study specific trainingto all team members, ensuring that the training is documented and thedocumentation filed in the Data Management Study files.
Assess the training needs of study team members on anongoing basis.
Provide refresher training to team members as required.
Provide feedback to the DMPM on issues with study teammember performance.
Represent Data Management at internal/external audits and manage findings through resolution both operationally and within the Quality ManagementSystem
Support the DMPM in the delivery of training tocross-functional study team members both internal and external (e.g. trainingin the study specific electronic CRF for monitors or Site staff at the investigatorymeeting).
Role Requirements
To performthis job successfully, an individual must be able to perform each essentialduty satisfactorily. The requirements listed below are representative of theknowledge, skill, and/or ability required. Reasonable accommodations may bemade to enable individuals with disabilities to perform the essentialfunctions.
US/LATAM/CAN :A minimum of 3 year relevant clinical research industryexperience.
EU/APAC:Prior relevant clinical research industry experience.
Experienceof at least one of ICON preferred CDMS (e.g. Rave, Inform, Oracle Clinical,OCRDC, UX EDC)
Highlycomputer literate, including strong Microsoft Office skills (Excel, Word,PowerPoint, Project)
Excellentcommunication and interpersonal skills, both verbal and written skills.
Strongclient 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 projectand prioritize accordingly.
Bachelordegree or local equivalent in a scientific and/or appropriate experience
Benefits of Working in ICON
Other than working with a great team of smart and energeticpeople, we also offer a very competitive benefits package. This variesfrom country to country so a dedicated recruiter will discuss this with you atinterview stage.
We care about our people as they are the key to our success.We provide an open and friendly work environment where we empower people andprovide them with opportunities to develop their long term career.
What's Next?
Following your application you will be contacted by one ofour dedicated recruiters and if successful we will be able to provide you withmore details about this opportunity.
ICON is an equal opportunity employer - M/F/D/V andcommitted to providing a workplace free of any discrimination or harassment.
ICON is an equal opportunity employer -Minorities/Females/Disabled/Veterans and committed to providing a workplacefree of any discrimination or harassment.



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