Clinical Data Lead
Division: ICON Early Phase
Location - Chennai/Trivandrum
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).
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
What you need:
- Bachelor's degree or local equivalent in a scientific discipline and/or appropriate experience
- A minimum of 7+ years clinical data management
- 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)
- Ability to coordinate DM study management.
- Excellent communication and interpersonal skills, both verbal and written
- Strong client relationship management skills, and the aptitude to develop this further
Why join us?
Ongoing development is vital to us, and as a Clinical Data Lead, you will have the opportunity to progress your career, with the potential to move into other related areas to enhance your skill set. Our benefits package is competitive, our scope is international and we genuinely care about our people and their success.
ICON is an equal opportunity employer and committed to providing a workplace free of any discrimination or harassment.
EOE race/color/religion/sex/sexual orientation/gender identity/disability/vet/national origin