Clinical Data Manager - Remote inside México

Capgemini; Guadalajara; A distancia; MXN 736,000 - 1,105,000; Jornada completa

Descripción de la vacante

A global leader in engineering services is seeking a skilled individual for clinical data management operations. This role requires a Bachelor's in life sciences and 2+ years of data management experience, focusing on data review and vendor reconciliation. The company promotes flexibility and professional growth in an inclusive work environment.

Servicios

Excellent compensation and benefits

Flexibility and balance

Career path and training

Inclusive culture

Formación

• At least 2 years of core clinical data management experience is required.
• Prior experience in external data vendor reconciliation and SAE reconciliation is required.
• Prior experience of EDC UAT is preferred.

Responsabilidades

• Responsible for clinical data management operations and activities.
• Review CRF/eCRF data for completeness, accuracy, and consistency.
• Manage allocated tasks with minimal oversight, ensuring quality standards.

Conocimientos

Clinical data management

Data review and management

Database design and structure

User Acceptance Testing (UAT)

Educación

Bachelor’s degree in life sciences

Herramientas

Electronic Data Capture Systems (Medidata Rave, Veeva EDC)

Descripción del empleo

Your role

At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world’s most innovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as they provide unique R&D and engineering services across all industries.

Join us for a career full of opportunities. Where you can make a difference. Where no two days are the same.

Responsibilities

• Responsible for clinical data management operations and activities such as data review (Query management, data listings review etc.) including external lab vendor and SAE reconciliations
• Deep understanding of the requirements for Good Clinical Data Management services, including its documentation; the relevant therapeutic indications, study hypotheses, and trial design; and have a solid understanding of database design and structure.
• Support Internal Clinical Data Management Initiatives
• Complete assigned Data Management Operations/Activities
• Review CRF/eCRF data for completeness, accuracy, and consistency via system edits and manual data checks (data review listings)
• Contribute to Project Success by conducting duties per LDM/Study lead request.
• Freeze and/or lock eCRFs (as appropriate) within the Electronic Data Capture System (Medidata rave, Veeva EDC etc.)
• Perform SAE & external vendor reconciliations.
• Code data per selected coding dictionaries if applicable.
• Participate in User Acceptance Testing (UAT) under supervision of the Study Lead.
• Assist with data transfers, loading and integration.
• Complete all required documentation per client and project requirements
• Manage allocated tasks with minimal oversight, ensuring deliverables meet quality standards and customer expectations

Qualifications

• Bachelor’s degree in life sciences is required.
• At least 2 years of core clinical data management experience is required.
• Prior trial responsibility for the entire data management life-cycle is desirable.
• Prior experience in external data vendor reconciliation and SAE reconciliation is required.
• Prior experience of EDC UAT is preferred.

What you’ll love about working here

• Excellent compensation and benefits
• Flexibility and balance with your personal and professional life.
• Career path, trainings and real growth opportunities
• Engaging and challenging projects.
• Inclusive and Collaborative Culture
• Open and Effective management.

Capgemini is a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fueled by its market leading capabilities in AI, generative AI, cloud and data, combined with its deep industry expertise and partner ecosystem.

At Capgemini Mexico, we aim to attract the best talent and are committed to creating a diverse and inclusive work environment, so there is no discrimination based on race, sex, sexual orientation, gender identity or expression, or any other characteristic of a person. All applications welcome and will be considered based on merit against the job and/or experience for the position.