Clinical Data Manager

ICON Strategic Solutions; Warszawa; On-site; PLN 150,000 - 190,000; Full time

Job summary

ICON Strategic Solutions is seeking a Clinical Data Manager to join our client-dedicated team. You will own data management activities from study start-up to close-out, ensuring accurate and inspection-ready data for global projects.

You will collaborate with study teams and vendors, perform EDC review and data cleaning, and contribute to database lock readiness, with a focus on data quality and timely delivery within a fast-paced environment.

Qualifications

• Bachelor's degree in a Life Sciences related discipline.
• 5+ years of Clinical Data Management experience in CRO/pharma/biotech.
• Experience leading studies from start-up through database lock.
• Strong hands-on EDC review, data cleaning, query management, external data reconciliation and UAT.
• Clear communication and ability to work independently within global study teams.
• Veeva EDC experience is desirable but not essential.

Responsibilities

• Lead or co-lead data management activities across assigned studies from start-up through close-out.
• Perform EDC data review, data cleaning, query management and reconciliation of external data sources.
• Create and maintain study documentation, including Data Management Plans, Data Review Plans, eCRF Completion Guidelines and Edit Check Specifications.
• Conduct EDC and data validation listing UAT and support database lock readiness.
• Partner with study teams and vendors to resolve data issues, including eCOA, PK, biomarker, local laboratory and safety data discrepancies.
• Support SAE and protocol deviation reconciliation, issue log maintenance, metrics reporting and eTMF filing.

Skills

Data management

EDC review

Data cleaning

Query management

Communication

Independence

Veeva EDC

Education

Bachelor's degree in Life Sciences

Tools

Veeva EDC

Job description

Clinical Data Manager (ICON Job Title: Clinical Data Science Lead)

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

As a Clinical Data Manager within ICON Strategic Solutions, you will be dedicated to one of our global pharmaceutical partners, working within a collaborative client-dedicated model. You will play a key role in delivering accurate, reliable, and inspection-ready clinical data that supports the development of innovative therapies for patients worldwide.

This is a hands-on opportunity for an experienced Clinical Data Manager who enjoys study ownership, data review, vendor collaboration and driving data quality from study start-up through database lock and close-out.

What You Will Be Doing

• Lead or co-lead data management activities across assigned studies from start-up through close-out.
• Perform EDC data review, data cleaning, query management and reconciliation of external data sources.
• Create and maintain study documentation, including Data Management Plans, Data Review Plans, eCRF Completion Guidelines and Edit Check Specifications.
• Conduct EDC and data validation listing UAT and support database lock readiness.
• Partner with study teams and vendors to resolve data issues, including eCOA, PK, biomarker, local laboratory and safety data discrepancies.
• Support SAE and protocol deviation reconciliation, issue log maintenance, metrics reporting and eTMF filing.

You Will Have/be

• Bachelor's degree in a Life Sciences related discipline.
• 5+ years of Clinical Data Management experience within a CRO, pharmaceutical or biotechnology environment.
• Experience leading or co-leading studies from start-up through database lock and close-out.
• Strong hands-on EDC review, data cleaning, query management, external data reconciliation and UAT experience.
• Clear communication skills and the ability to work independently within fast-paced global study teams.
• Veeva EDC experience is desirable but not essential.

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.

Our 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 maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

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, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.