As a Program Manager, Clinical Data Science, you will join the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
What you will be doing:
1. Provide strategic leadership in Clinical Data Management across the lifecycle of clinical trials, from Case Report Form (CRF) development through to Clinical Study Report (CSR), ensuring the integrity and accuracy of clinical data.
2. Oversee the design, development, and validation of electronic Case Report Forms (eCRFs) and data validation edit checks, ensuring alignment with the client's standards and regulatory requirements.
3. Act as the primary Data Management representative on study teams, collaborating with cross-functional stakeholders to drive study planning, execution, and the delivery of high-quality clinical data on time.
4. Develop and implement Data Management Plans (DMPs), quality oversight strategies, and risk mitigation processes, leveraging data analytics and study metrics to monitor data quality and study progress.
5. Manage vendor and Functional Service Provider (FSP) partner performance, providing oversight and guidance to ensure deliverables meet predefined quality standards and timelines; support audits, inspections, and Corrective and Preventive Action (CAPA) execution.
6. Mentor and support Clinical Data Managers, contributing to process improvement initiatives, promoting best practices, and fostering a collaborative, audit-ready work environment.
You are:
1. Bachelor's degree, preferably in a scientific discipline such as Statistics, Mathematics, Economics, Computer Science, IT, Biology, Social Science, etc.
2. 7+ years relevant work experience with a focus on clinical data management, 4+ years as a Trial Data Manager with full accountability across study start-up, conduct, and lock.
3. Robust experience with EDC (e.g., Medidata Rave) and use of Data Review tools such as J-Review or Business Objects required.
4. Deep understanding of drug development and the biopharmaceutical industry required.
5. Exceptional project management skills, with the ability to effectively lead and collaborate with various business functions; project management certification is desirable.
6. High attention to detail, including proven ability to manage multiple, competing priorities.
7. Experience overseeing outsourced clinical trials work.
8. Demonstrated ability to establish effective business relationships with external stakeholders, including implementing process change at a vendor.
9. Deep knowledge of the clinical data management outsourcing operating model to functional-service providers and full-service/global CROs.
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 benefits designed to support your well-being and work-life balance, including:
* Various annual leave entitlements
* A range of health insurance options for you and your family
* Competitive retirement planning options
* Global Employee Assistance Programme, TELUS Health, providing 24-hour access to support professionals
* Life assurance
* Flexible, country-specific benefits like childcare vouchers, bike schemes, gym discounts, travel passes, health assessments, etc.
Visit our careers website to learn more about working at ICON.
At ICON, inclusion & belonging are fundamental. We are committed to providing an inclusive, accessible environment for all candidates and a workplace free of discrimination and harassment. If you need a reasonable accommodation during the application process, please let us know through this form.
Interested but unsure if you meet all requirements? We encourage you to apply — you might be exactly who we're looking for.
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