Project Data Manager

Contenu de l'offre Project Data Manager chez Excelya

Project 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.

The Project Data Manager is responsible for the project management of all the data management services for the assigned projects. Ensures the contracted Data Management activities for projects are carried out by the Client’s SOPs and expectations

Key activities :

Deeply acknowledges and strictly follows applicable Excelya and Client’s SOPs.
Acts as Functional Lead for Data Management including primary DM contact for Sponsors and for internal liaison between Data Management and Project Management, Clinical Monitoring, and other functional groups.
Coordinate the work of the assigned Data Management team.
Ensures launch, delivery and completion of all Data Management activities and milestones according to contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulations.
Monitors and communicates project progress to the Sponsor and project team including use of project status reports and tracking tools/metrics to enable in stream data collection and query management.
Plan, manages, and requests resources for assigned projects.
Develop and maintain project plans, specifications, and documentation in line with SOP requirements.
Maintains documentation on an ongoing basis and ensures that all TMF filing is complete and up to date.
Participates in, and presents at internal, Sponsor, third-party, and investigator meetings.
Provides project specific training to internal and external audiences as required.

Profile :

Bachelor’s degree qualification in a Scientific discipline is preferred
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)
Ability to travel as necessary (up to 25%)










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