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 : Clinical Data Lead
Job Description
This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. 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.
Overview of the Role
- Review all activity on an ongoing basis to identify out of scope tasks and bring to the attention of the DMPM and Contract Analyst and Compile the change order log for review by the DMPM
- Develop an understanding of the revenue recognition and revenue forecasting process; perform revenue recognition and revenue forecasting process on a monthly basis for review by the DMPM
- Lead the development of the specifications, implementation, testing for the eCRF or paper CRF edit checks, data review, oversight listings (DVS) data management plan, study specific procedures and specifications for custom reporting on the study
- Perform project planning tasks and support the DMPM in the development of the project plan and timelines
- Set up and maintain data management study files for inclusion in the Trail Master File, ensuring these are maintained in an audit ready state for review by Sponsor, Regulatory or ICON Auditors
- 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
Candidate Profile :
· Bachelor’s degree or local equivalent in a scientific discipline and/or appropriate experience
· A minimum of 7 years clinical data management or other relevant experience Currently working as a Team Lead/ Associate Data Lead
· Experience of at least one of ICON preferred CDMS (Rave, Inform, Oracle Clinical, 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
Additional Information:
Location: Chennai
Industry Type: Pharma/ Biotech/Clinical Research
Reference: 043820
End Date: 30th May, 2017
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