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About the role
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Position : Clinical Data Lead
Career Level : F
Location : Chennai/ Bangalore / Home based for right candidates{India]
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
Role Requirements / Skills / Experience Required
· 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
Benefits
Working for ICON you will be provided with an excellent benefits package.
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 and provide them with opportunities to develop their long term career.
In addition you will have the opportunity to develop within your role and take on further responsibilities or develop your skill set within other related departments of ICON.
What’s Next
Following your application if you are successful you will be invited to an initial telephone interview with one of our dedicated recruiters who will be able to provide you with more details of this opportunity.
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. See all locations Read more
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