Configuration & QC Specialist I and II

ICON Clinical Research; Ciudad de México; Hybrid; MXN 350.000 - 550.000; Vollzeit

Benefits dieser Stelle

Health insurance

Annual leave

Retirement planning

Employee assistance program

Life insurance

Country-specific benefits

Zusammenfassung

ICON is a global healthcare intelligence and clinical research organisation seeking an experienced Configuration & QC Specialist II in CDMX. You will design and analyze clinical trials, interpret complex medical data, and help advance innovative treatments.

You will configure and maintain clinical trial databases and EDC systems (Medidata Rave, Oracle Clinical, Inform), perform QC checks, collaborate with data management and statistics teams, and coach junior staff on best practices and

Qualifikationen

• Bachelor's degree in a relevant scientific discipline or healthcare-related field.
• 3+ years of experience in clinical data management, data validation, or related role, preferably within the pharmaceutical or biotechnology industry.
• Proficiency in clinical trial databases and electronic data capture (EDC) systems, such as Medidata Rave, Oracle Clinical, or Inform.
• Strong attention to detail, analytical skills, and problem-solving abilities, with the ability to effectively identify and resolve data-related issues.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with colleagues at all levels of the organization.
• Proven ability to work independently and manage multiple priorities in a fast-paced, deadline-driven environment.

Aufgaben

• Configuring and maintaining clinical trial databases and EDC systems, ensuring accuracy, functionality, and compliance with regulatory requirements.
• Performing comprehensive quality control (QC) checks on clinical trial data and study documentation, identifying discrepancies, inconsistencies, and data entry errors.
• Collaborating closely with cross-functional teams including data management, biostatistics, and clinical operations to address QC findings and implement corrective actions.
• Leading the development and execution of validation plans and procedures to assess the performance and reliability of EDC systems and data management processes.
• Providing training, guidance, and support to junior team members on system configuration, data entry guidelines, and QC processes to promote best practices and continuous improvement.

Kenntnisse

Clinical data management

Quality control

Data validation

Attention to detail

Analytical skills

Communication skills

Ausbildung

Bachelor's degree in a relevant scientific discipline or healthcare-related field

Tools

Medidata Rave

Oracle Clinical

Inform

Jobbeschreibung

Office-Hybrid (3 day at the office) CDMX

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

As a Configuration & QC Specialist II at ICON, you will design and analyse clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies.

What You Will Do:

You will take responsibility for configuration and database systems deliverables, applying your skills to ensure quality and efficiency.

Key responsibilities include:

• Configuring and maintaining clinical trial databases and electronic data capture (EDC) systems, ensuring accuracy, functionality, and compliance with regulatory requirements.

• Performing comprehensive quality control (QC) checks on clinical trial data and study documentation, identifying discrepancies, inconsistencies, and data entry errors.

• Collaborating closely with cross-functional teams including data management, biostatistics, and clinical operations to address QC findings and implement corrective actions.

• Leading the development and execution of validation plans and procedures to assess the performance and reliability of EDC systems and data management processes.

• Providing training, guidance, and support to junior team members on system configuration, data entry guidelines, and QC processes to promote best practices and continuous improvement.

Your Profile:

You will bring relevant configuration and database systems experience, along with the following qualifications and skills.

Required qualifications and experience:

• Bachelor's degree in a relevant scientific discipline or healthcare-related field

• 3+ years of experience in clinical data management, data validation, or related role, preferably within the pharmaceutical or biotechnology industry.

• Proficiency in clinical trial databases and electronic data capture (EDC) systems, such as Medidata Rave, Oracle Clinical, or Inform.

• Strong attention to detail, analytical skills, and problem-solving abilities, with the ability to effectively identify and resolve data-related issues.

• Excellent communication and interpersonal skills, with the ability to collaborate effectively with colleagues at all levels of the organization.

• Proven ability to work independently and manage multiple priorities in a fast-paced, deadline-driven environment.

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 (https://careers.iconplc.com/benefits) 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.

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 (https://careers.iconplc.com/reasonable-accommodations)