ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. We specialize in the strategic development, management and analysis of programs that support Clinical Development – from compound selection to Phase I - IV clinical studies
ICON enjoys a strong reputation for quality and is focused on staff development. We make it our mission to attract the most diverse and creative minds into the business and we continually strive to provide opportunities for our people to excel, grow and build a great career. We understand that our greatest asset is the skills and talents of our people and they are truly what set us apart.
Post: CDL
Summary
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 Project Manager / Sr. Project Manager, Data Management.
Job Description:
• Ensure all work performed is of high quality, compliant with Good Clinical Practice, ICH Guidelines and all applicable laws and regulations.
• Complete all assigned training (including the CDL Development Program) and courses in the ICON Training Management system (iLearn); ensuring that mandatory courses are all completed before the designated date and that the required system specific training has been completed for current studies.
• Record all billable and non-billable time in the appropriate timesheet management system
• 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 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.
• Set up and maintain data management study files for inclusion in the Trial Master File, ensuring
Role Requirements / Skills / Experience Required
• A minimum of 8+ year’s relevant clinical research industry experience. EU/APAC: Prior relevant clinical research industry experience.
• 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.
Additional Information:
Location: Chennai / Trivandrum
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CDL
Reference: 048702
End Date: 30th January, 2018
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