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.
Key Responsibilities
We are seeking a talented and motivated Medtech CRA to join and manage clinical activities of our client in the pharmaceutical industry. The Expert will oversee performance of appointed study sites, conducting company initiated clinical studies. Responsible for monitoring, communication, and deliverables for the assigned study sites.
Key Responsibilities
- Verify safety and well-being of study subjects are maintained for assigned study sites.
- Support the operational execution of clinical trials and ensure collection of high quality, substantiated data.
- Execute clinical trials activities following established standard operating procedures, good clinical practices and regulatory requirements.
- Accountable for study site performance and providing high quality data according to overall project timeline.
- Assist Clinical Operations staff and study site staff to quickly and effectively resolve issues. Responds to problems and assists in implementing corrective and preventive actions, if required.
- Performs site visits and ensures study site is compliant with the study protocol and all Federal, State, local, and company regulations, policies and procedures.
- Understand the business value of clinical projects and balances overall business objectives and functional needs.
- Interface and collaborate with Investigators, IRBs/ECs,contractors/vendors.
Your Profile
- Bachelor’s degree with at least 2 years of relevant experience; master’s or PhD/MD/PharmD with at least 1 year of relevant experience.
- Previous clinical research experience required.
- Previous medical device monitoring or equivalent experience required.
- Requires understanding and application of regulations and standards applied in clinical research areas and medical devices/combination products.
- Relevant industry certifications preferred (i.e., CCRA, RAC, CDE).
- Fluent in English and professional level of French and Dutch .
What You Will Love About Working Here
- At Capgemini Belgium we offer flexibility in more than one way: next to our hybrid way of working, where we offer you can work 70% from home, we also offer our flex abroad program. With this program you can work up to 45 days abroad, this to maintain a good work-life balance.
- Our mission is your career path. Our array of career growth programs and diverse professions are crafted to support you in exploring a world of opportunities.
- OUTfront, Women@Capgemini or CapAbilityare 3 examples of employee led networks dedicated to advance diversity, equity and inclusion within workplace and society.
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.
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.
