Lead Data Manager

ICON Strategic Solutions; España; Presencial; EUR 70.000 - 100.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual leave

Health insurance

Retirement planning

Employee assistance program

Life assurance

Flexible benefits

Descripción de la vacante

ICON Strategic Solutions seeks a Lead Data Manager to drive data science initiatives within study start-up clinical trials, ensuring analyses deliver actionable insights for strategic decisions.

You will lead day-to-day data science activities, collaborating with SET, MDR, Programming, and Data Management teams to ensure timely go-live and compliant configurations.

Formación

• Bachelor's degree in life sciences, computer science, or related field.
• Extensive experience in data analysis and project leadership within a clinical research setting.
• Strong expertise in statistical software and data visualization techniques.
• Excellent communication and leadership skills, with the ability to foster collaboration across diverse teams.
• Willingness to travel as required (approximately 15%).

Responsabilidades

• Lead end-to-end clinical data management start-up activities from protocol review through specification development, database build, testing, validation, and production go-live.
• Review protocols to identify data collection requirements and impacts on database design.
• Translate protocol requirements into study build specifications including eCRFs, visits, and edit checks.
• Apply CDISC standards and standardized forms for compliant study configuration.
• Coordinate with cross-functional teams to clarify requirements and resolve discrepancies.
• Plan, coordinate, and oversee sandbox testing and UAT, including defect documentation and retesting.
• Manage start-up timelines, dependencies, risks, and go-live readiness.
• Assess data management impact of protocol amendments and post-go-live changes.
• Maintain start-up documentation in the eTMF and ensure SOP compliance.

Conocimientos

Clinical data management

Project leadership

CDISC standards

Data analysis

Data visualization

Communication

Travel

Educación

Bachelor's degree in life sciences or related field

Bachelor's degree in computer science

Herramientas

SAS

R

Tableau

Descripción del empleo

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.

As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

As a Lead Data Manager at ICON, you will drive data science initiatives within study start up clinical trials, ensuring that our analyses provide meaningful insights that inform strategic decisions.

What You Will Do

You will manage day-to-day clinical data science activities, supporting your team to deliver quality outcomes.

Key Responsibilities Include

• Lead end-to-end clinical data management start-up activities from protocol review through specification development, database build, testing, validation, and production go-live.
• Review draft and approved protocols to identify data collection requirements, build risks, inconsistencies, and potential impacts to database design or downstream processes.
• Translate protocol requirements into complete and accurate study build specifications, including visit schedules, assessments, eCRFs, dosing, data collection requirements, and edit check specifications.
• Apply clinical data standards, including CDISC standards, eCRF design principles, field and variable conventions, and approved standard forms, to ensure consistent and compliant study configuration.
• Partner with the Standards team to leverage existing standards and define, document, and implement protocol-specific modifications when needed.
• Collaborate with Study Execution Teams (SET), Medical Data Review (MDR), Programming, Data Management, Standards, and other cross-functional stakeholders to clarify requirements, resolve discrepancies, and coordinate study configuration activities.
• Plan, coordinate, and oversee sandbox testing and user acceptance testing (UAT), including documentation of defects, issue resolution, retesting, and confirmation of system readiness.
• Manage start-up timelines, dependencies, deliverables, risks, and issue-resolution activities to ensure timely and successful database go-live.
• Assess and manage the data management impact of protocol amendments and post–go-live changes, including updates to specifications, system configuration, testing, validation, and documentation.
• Maintain complete, accurate, and timely data management start-up documentation in the eTMF.
• Ensure all data management start-up deliverables comply with applicable SOPs, ICH-GCP, regulatory requirements, and internal quality standards.

Your Profile

You will have solid clinical data experience, with the ability to manage competing priorities and develop your team.

Required Qualifications And Experience

• Bachelor's degree in life sciences, computer science, or a related discipline
• Extensive experience in data analysis and project leadership within a clinical research setting.
• Strong expertise in statistical software and data visualization techniques.
• Exceptional analytical and problem-solving skills, with a focus on translating data into actionable insights.
• Excellent communication and leadership skills, with the ability to foster collaboration across diverse teams.
• Willingness to travel as required (approximately 15%)

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.

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.

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 or submit a request here