Project Data Manager H/F Excelya
Paris - 75 CDI- Bac +3, Bac +4
- Bac +5
- Industrie Pharmaceutique • Biotechn. • Chimie
Les missions du poste
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 an Project Data Manager to strengthen our commitment to delivering high-quality products. In this pivotal role, you will lead quality assurance processes, ensure regulatory compliance, and drive continuous improvement initiatives.
Main Activities :
- Deeply acknowledges and strictly follows Client's and Excelya SOPs, guidelines and appropriate local and international legislation.
- 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.
- Responsible for financial management of assigned projects, including revenue recognition, changes in scope, including liaison with Finance and Contracts groups as needed.
- 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.
Le profil recherché
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.
About You
We are looking for candidates who embody our values of Audacity, Care, and Energy :
- Bachelor's degree qualification in a Scientific discipline is preferred
- Five or more years as a Data Manager and 4 years acting as a Lead 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 regula-tory compliance · Understanding of recommended CDM best practices and associated documentation
- Fluent in local language and English (written and spo-ken)
- Ability to travel as necessary (up to 25%)
Bienvenue chez Excelya
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 our values Energy, Care and Audacity.
Founded in 2014 and headquartered in Paris, France, 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.
We take a one-team approach to work : our shared success is the result of collaboration at every stage of a project, from regulatory affairs and clinical operations to quality assurance and strategic development.
Excelya is committed to helping our clients deliver life-changing therapies collaboratively, so we can transform tomorrow together.
Hellowork a estimé le salaire pour ce métier à Paris
Le recruteur n'a pas communiqué le salaire de cette offre mais Hellowork vous propose une estimation (fourchette variable selon l'expérience).
Estimation basée sur les données INSEE et les offres d’emploi similaires.
Estimation basse
43 800 € / an 3 650 € / mois 24,07 € / heureSalaire brut estimé
53 200 € / an 4 433 € / mois 29,23 € / heureEstimation haute
67 500 € / an 5 625 € / mois 37,09 € / heureCette information vous semble-t-elle utile ?
Merci pour votre retour !
- Paris - 75
- CDI
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