About the Job
Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.
This role is an exciting opportunity to contribute to a dynamic, ambitious team in Data Management. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.
The Technical Data Manager is responsible for performing Technical Data Management tasks per client work orders to high regulatory standards and Excelya Group SOPs.
Main Responsibilities
- Responsible for CRF design (Unique) in the EDC database, screens design, Data Validation Plan writing, edit checks programming in EDC database as per the study specifications, and writing listings specifications.
- Work closely with the Data Manager & Lead Data Manager responsible for the study under the supervision of more senior staff (Manager or Senior TDM)..
- Responsible to maintain global libraries in EDC database.
- Participate to study documentation, Maintain the updated documents related to the technical specifications.
- Adherence to the internal technical QC and document updates.
Requirements
- About You
At Excelya, taking audacious steps is encouraged, so we’re looking for individuals who are ready to grow with us and share our values.
• Experience:
Four or more years as a Technical Data Manager or equivalent combination of education, training, and experience
• Skills:
· Knowledge and understanding of ICH GCP and other relevant ICH, EU or FDA guidelines to maintain regulatory compliance
· Experience in clinical trial databases and applications, clinical data flow, data review, and eCRF Report Form design and Edit checks (Rule) designing as per the specification provided.
· Understanding of clinical trials and study lifecycle (start-up, maintenance & closeout) and ossociated CDM best practices and documentation
· Proficient in computer technology used in an office environment (Word, Excel, PowerPoint, MS Project, etc).
· Understanding Java Script and programming best practices.
· Good Understanding of Oracle Clinical One is a Plus
· Effective verbal and written communication skills
• Education:
Bachelor’s degree qualification in a Scientific field is preferred
• Languages:
Fluency in English
Benefits
Why Join Us?
At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.
Here’s what makes us unique.
We are a young, ambitious health company representing 900 Excelyates, driven to become Europe’s leading mid-size CRO with the best employee experience. Our one-stop provider service model - offering full-service, functional service provider, and consulting - enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient's journey.
Watch our testimonial video to hear directly from our Excelyates about why Excelya is more than just a workplace—it’s a community built on values.
Apply today, become an Excelyate!
Skills Required
- Four or more years of experience as a Technical Data Manager, or equivalent education, training, and experience
- Knowledge of ICH GCP and relevant ICH, EU, or FDA guidelines
- Experience with clinical trial databases and applications
- Experience with clinical data flow, data review, eCRF design, and edit-check rule design
- Understanding of clinical trials, study lifecycle, clinical data management best practices, and documentation
- Proficiency with office technology including Word, Excel, PowerPoint, and MS Project
- Understanding of JavaScript and programming best practices
- Effective verbal and written communication skills
- Fluency in English
- Bachelor's degree in a scientific field
- Understanding of Oracle Clinical One
What We Do
Excelya is an independent partner that serves Biotech, Pharma, and Medical Device organizations with a comprehensive range of Full-service CRO, FSP, and Resourcing solutions guided by compassion, care, and excellence. Founded in 2014 and headquartered in Paris, France, and operating in 28 countries across Europe, USA and India, Excelya has a global team of 900+ experts who understand the critical needs of clients to provide bespoke and robust trial solutions across a broad spectrum of therapeutic areas, with speciality focus on Oncology & Hematology, Rare Disease & Pediatrics, Infectious Disease, Inflammation & Immunotherapy, Pain Treatment & CNS, and Late Phase & RWE.
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