Documentary System Project Manager R&D H/F - 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.About the Job

Join Excelya as a Business Expert: Documentary System Project Manager and take a leading role in the transformation of clinical research documentation processes across our organization. You will spearhead initiatives aimed at enhancing our documentary systems, ensuring compliance with regulatory requirements, and improving operational efficiency.

In this strategic position, you will engage with various stakeholders to gather requirements, analyze current processes, and implement innovative solutions that streamline project activities.

Main Responsibilities:

Are you passionate about digital transformation and regulatory excellence in R&D?

We're looking for a Document Management & Systems Lead to manage and optimize the document management platforms, ensuring high standards of compliance and efficiency.

You'll act as the bridge between science, quality, and technology, leading key projects that shape the future of documentation in pharmaceutical research.

1) Functional administration:

-Functional administration of the databases

-Follow up of issues and improvements

-Management of evolution and releases as Business Expert

-Follow-up of the system validation status

-Redaction of SOP and training materials

-User assistance

-Management of training, and maintenance of e-learnings

-Service provider coordination

2)Improvement of business process: To faster and improve business process by the use of information systems

3)Flagship projects (new information systems):

- Leading operational and steering committee

-Writing URS in collaboration with key users

-Review of Functional Specifications

-Ensuring contact with IT, Legal, QA staff involved in the project

-Ensuring project management follow-up

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'sleading mid-size CROwith thebest employee experience. Ourone-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 caremeans 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 a proactive and detail-oriented Project Manager with a strong background in documentary systems in clinical research or a related field.

- Experience: Knowledge of SharePoint and Documentum (or another eDMS) environments.
- Education: Bachelor's or Master's degree in Science, or a related discipline.
- Languages: Fluency in French and English is essential
- Location: Hybrid is preferred. Remote also could be considered.

Embrace the opportunity to drive positive change at Excelya, where we believe in audacious growth and impactful solutions!