Lead Clinical Data Manager

Contenu de l'offre Lead Clinical Data Manager chez Excelya

Lead Clinical Data Manager

Created in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care.

We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 900 Excelyates. Our unique one-stop provider service model – leveraging full-service, functional service provider and consulting – allows our Excelyates to evolve through a diverse array of projects. In collaboration with preeminent experts, Excelya advances scientific, managerial and human knowledge to improve the patient journey.

For our team members, excelling with care means benefitting from a stimulating professional environment that encourages personal, intellectual, and operational participation so that together we can be the best in our field. We commit to giving each Excelyate the means to express their natural talents, develop their full potential and invest their unique selves in our unique project.

Key activities :

Deeply acknowledges and strictly follows applicable Excelya and Client’s SOPs.
Responsible for data cleaning, data review, discrepancy management and data reconciliation activities on the studies assigned to him/her.
Work closely with the Lead Data Manager responsible for the study.
Generate study metrics and status reports within and across several studies.
Participate to study documentation archiving.
Participate in EDC database build and testing through go live.
Complete Excelya administrative tasks as required e.g., timesheets, CV and training updates.
May undertake other tasks as they may be assigned from the supervisor that will concern any of the Excelya Group companies.

Profile :

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 eCase Report Form design.
Understanding of clinical trials and study lifecycle (start-up, maintenance & closeout)
Proficient in computer technology used in an office environment (Word, Excel, PowerPoint, MS Project, etc).
Ability to maintains high level of professionalism, ethics and compliance at all times.
Effective verbal and written communication skills
Fluent in local language and English (written and spoken)










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