Job Description

Why Join Us?
At Excelya, we are committed to excellence in healthcare, and we invite you to be part of our dedicated team where your expertise can make a significant impact.
As a young, ambitious health company with over 900 talented professionals, we strive to be Europe's leading mid-size CRO, delivering the best employee experience. Our integrated service model enables you to engage in diverse projects, working alongside industry experts to enhance scientific knowledge and improve the patient journey.
About the Job
We are seeking a Technical Data Manager, who will be 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.
• 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.
• Completes Excelya administrative tasks as required e.g., timesheets, CV and training updates. Compliance to the customer trainings is also mandatory.
• May undertake other tasks as they may be assigned from the supervisor that will concern Excelya and the customer.
• Deeply acknowledges and strictly follows Excelya and Client's SOPs, guidelines and appropriate local and international legislation.
• Works under the supervision of more senior staff (Manager or Senior TDM).

Requirements
About You
We are looking for candidates who embody our values of Audacity, Care, and Energy:

• Bachelor's degree qualification in a Scientific field is preferred.
• At least 2-3 years of experience as a Technical Data Manager or equivalent combination of education, training, and experience.
• Knowledge and understanding of ICH GCP and other relevant ICH, EU or FDA guidelines to maintain regulatory compliance.
• Understanding of recommended CDM best practices and associated documentation.
• 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).
• Good Understanding of Oracle Clinical One is a Plus.
• Proficient in computer technology used in an office environment (Word, Excel, PowerPoint, MS Project, etc).
• Understanding of Java Script and programming best practices.
• Fluent in local language and English (written and spoken).

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.
Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.

Skills Required