Technical Data manager

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.  

• →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.

• 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