Clinical Data Lead

4 weeks ago

Bristol, Bristol, United Kingdom Pharmiweb Full time
About the Role

We are seeking a highly skilled Clinical Data Lead to join our team at ICON plc. As a Clinical Data Lead, you will play a key role in supporting the design, specifications, and development of eCRFs, ensuring adherence to Sponsor standards throughout.

Key Responsibilities
  • Support the development of Data Management Plan documents that ensure delivery of accurate, timely, consistent, and high-quality clinical data.
  • Coordinate the development and testing of clinical data management systems edit checks and listings/reports/tools for data review and discrepancy management activities.
  • Work with Third Party/External data Vendors to complete the set-up of data import and reconciliation processes.
  • Perform comprehensive review of all data generated from the clinical study, including Third Party/External data, SAE data, and local lab data, as applicable.
  • Oversee quality control procedures and develop and maintain strong communications and working relationships with the CDM team.
  • With guidance from the Principal Clinical Data Lead or Manager, effectively manage project timelines and quality.
  • Provide reports, status updates, feedback, and advice to key study stakeholders on the progress of data cleaning and risk identification/mitigation activities.
  • Ensure CDM activities are performed in compliance with Good Clinical Practice, ICH Guidelines, Biogen SOPs, Job Aids, regulatory guidelines, and study-specific plans.
  • Apply appropriate best practices and independently offer project solutions to the study team.
  • Support the filing of eTMF documentation to ensure that an inspection-ready environment is maintained throughout the study lifecycle.
  • Support and assist subordinate staff for assigned trials, impacting quality, timeliness, and effectiveness of the team.
  • Provide backup support for the Principal Clinical Data Lead as required.
Requirements
  • Bachelor's degree preferred, preferably in a scientific discipline such as Statistics, Mathematics, Economics, Computer Science, IT, Biology, Social Science, etc.
  • 4+ years of Clinical Data Management experience.
  • Ability to work under pressure, demonstrating agility through effective and innovative team leadership.
  • Robust experience with EDC (e.g. Medidata Rave) and use of Data Review tools such as elluminate, J-Review or Business Objects required.
  • Deep understanding of drug development and biopharmaceutical industry required.
  • Strong technical skills, including experience working with using Microsoft Excel functionality.
  • Fluent English (oral and written).
  • High attention to detail, including proven ability to manage multiple, competing priorities.
  • Excellent written and oral communication skills.
About ICON

At ICON, diversity, inclusion, and belonging are fundamental to our culture and values. Our rich diversity makes us more innovative, which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organization. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

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