Clinical Data Manager (CDM)

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

• Support Internal Clinical Data Management Initiatives
• Complete assigned Data Management Operations/Activities under the direction of Study Lead or Line Manager
• Review CRF/eCRF data for completeness, accuracy, and consistency via system edits and manual data checks (data review listings)
• Generate and resolve queries in alignment with data management plans
• 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, Oracle InForm, etc.)
• Perform external vendor reconciliations (e.g., lab, imaging data)
• Perform SAE reconciliation
• Code data per selected coding dictionaries (e.g., MedDRA, WHO Drug)
• Participate in User Acceptance Testing (UAT) under supervision of the Study Lead
• Assist with data transfers, loading and integration
• Create and distribute metric reports for study tracking and performance insights
• Complete all required documentation per EDETEK and project requirements
• Manage allocated tasks with minimal oversight, ensuring deliverables meet quality standards and customer expectations
• Collaborate closely with EDC vendors, sites, and cross-functional study teams
• May serve as backup for study leads or lead simple studies independently
  
  

Qualifications For Essential Functions

• Ability to communicate effectively in the English language in person, by phone and in writing
• Strong attention to detail and accuracy is a must
• Excellent organizational skills
• Ability to work collaboratively, effectively, and productively in diverse organization structures
• Ability to work in a team-oriented, collaborative environment
• Ability to work positively within a continually changing environment
• Ability to effectively prioritize and execute tasks in a high-pressure environment
• Familiarity with CDISC standards, GCP, and regulatory data compliance
• Demonstrated ability to work independently and lead study-level data operations
• Proven mentorship experience and ability to train junior staff
  
  

Education And Experience Required

• A bachelor's degree in life sciences is required
• A minimum of 5 years in Clinical industry
• A minimum of 2 years of core clinical data management experience is required
• Prior trial responsibility for the entire data management life-cycle is desirable
• Experience in specialty data functions such as coding, pharmacovigilance, or lab oversight
• Prior experience in external data vendor reconciliation and SAE reconciliation is required
• Prior experience of EDC UAT is preferred
• Must have exposure to studies in multiple therapeutic areas including Oncology
  
  

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 500 000 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.