Clinical Data Manager

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.

Job Description
The Clinical Data Manager (CDM) is 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. CDM is also responsible for EDC testing, data cleaning, and ensuring compliance with regulatory data standards (CDISC, SDTM). The role requires proficiency in EDC Systems (like Medidata Rave, Oracle InForm, Veeva vault) and strong knowledge of clinical trial processes.

The CDM should thoroughly understand the requirements for Good Clinical Data Management services, including its documentation; be willing to be involved in start-up or wrap-up of in-house and client-specific data management projects; understand the relevant therapeutic indications, study hypotheses, and trial design; and have a solid understanding of database design and structure.

Essential Functions

• Performs day-to-day DM tasks under the direction of Study Lead or Line Manager
• Perform ongoing data review, identifying discrepancies and ensuring data quality
• Conduct external data reconciliation (e.g., lab, imaging, SAE data)
• Generate and resolve queries in alignment with data management plans
• Create and distribute metric reports for study tracking and performance insights
• May serve as backup for study leads or lead simple studies independently
• Collaborate closely with EDC vendors, sites, and cross-functional study teams
• Contribute to study management by acting as backup for study leads or leading simple studies
• Demonstrated ability to work independently and lead study-level data operations
• Experienced CDMs may as backups for Study lead or may lead the simple studies

Experience Required

• At least 8 years of experience
• Proficiency in EDC Systems (like Medidata Rave, Oracle InForm, Veeva vault)
• Strong knowledge of clinical trial processes and regulatory data standards (CDISC, SDTM)
• Execute medical coding using standard dictionaries (e.g., MedDRA, WHO Drug)
• Familiarity with CDISC standards, GCP, and regulatory data compliance
• Execute medical coding responsibilities using dictionaries such as MedDRA and WHO Drug
• Proven mentorship experience and ability to train junior staff
• Experience in specialty data functions such as coding, pharmacovigilance, or lab oversight
• Medical coding (there is no separate role for this, CDMs are done the medical coding)

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.

What you will love about working here?

• We care about all our employees and want them to feel as comfortable as possible. That's why we offer them health insurance from the first days, regardless of the probationary period.
• The gift from the company - Christmas holidays from 25 December to 31 December.
• Сooperation with Superhumans center and Veteran HUB. Capgemini Engineering has supported the launch of psychological rehabilitation department of Superhumans. Our team also donnated over UAH prosthetics for three Ukrainian defenders. Currently, we support psychological counseling provided by the Veteran Hub, and we have implemented a internal policy making the company friendly to military and veterans with the assistance of the Hub.