About this opportunity
ICON Strategic Solutions lists this Clinical Data Science Lead opportunity in north township, Indiana. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Overview
Join to apply for the Clinical Data Science Lead role at ICON Strategic Solutions .
The Senior Clinical Data Manager will serve in a support-level capacity on a Clinical Data Management team to provide efficient and quality clinical data management products.
Responsibilities
Support the design, specifications, and development of eCRFs, ensuring adherence to standards throughout.
Coordinate the development and testing of clinical data management systems edit checks and listings/reports/tools for data review and discrepancy management activities.
Support the development of Data Management Plan documents that will ensure delivery of accurate, timely, consistent, and high-quality clinical data. Works 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.
Oversees quality control procedures.
Develop and maintain strong communications and working relationships with CDM team.
With guidance from 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, SOPs, Job Aids, regulatory guidelines, and study specific plans.
Apply appropriate best practices and independently offer project solutions to the study team.
Ensure activities that are performed are done in line with study timelines, with quality and in compliance with governing process.
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.
Impact quality, timeliness, and effectiveness of the team.
Provide back-up support for Principal.
What You Are
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 Microsoft Excel
Fluent English (oral and written)
High attention to detail including proven ability to manage multiple, competing priorities
Excellent written and oral communication skills
Bachelor’s degree preferred, preferably in Statistics, Mathematics, Economics, Computer Science, IT, Biology, Social Science, etc.
What ICON Can Offer You
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Benefits Examples Include
Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON:
At ICON, inclusion & belonging are fundamental to our culture and values. 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, colour, 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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Who can apply
Review the original listing for work authorization, qualifications and employer requirements.