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Clinical Data Lead (Remote)

US-Pennsylvania-North Wales
Permanent
Reference: 059272
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 Clinical Data Lead plays a key role within ICON Data Management by serving as the point of contact for day to day activities on studies with responsibilities for study set-up, supervising and/or participating in the on-going maintenance activities 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 (DMPM).
 
Overview of the Role
  • Lead the development of the specifications, implementation, testing for the Electronic Case Report Form (eCRF) or paper CRF and edit checks (DVS), data review, oversight listings, 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 Trial Master File, ensuring these are maintained in an audit ready state for review by Sponsor, Regulatory and/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
  • Review all activities on an on-going 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
Role Requirements / Skills / Experience Required
  • Bachelor’s degree or local equivalent in a scientific discipline and/or appropriate experience
  • A minimum of 5 years clinical data management or other relevant experience
  • Experience  in at least one of the 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  
  • Strong client relationship management skills, and the aptitude to develop this further
 
Benefits
Other than working with a great team of smart and energetic people, we also offer a very competitive 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.   
 
What’s Next?
Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.
 
ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment.
 
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