Global Access Project Manager H/F - 75

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, 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 Clinical Operations. 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.

Main Responsibilities

The Global Managed Access Project Manager is responsible for the coordination, implementation, and oversight

of global Managed Access activities. Responsibilities include, but are not limited to, the following:

Strategy & Program Design

- For any new product or indication (client development, new acquisition, or new licensing agreement), coordinate

the Managed Access strategy with internal stakeholders (global and local medical affairs, supply chain,

distribution, legal, market access, regulatory, pharmacovigilance, ethics, commercial, etc.).

- In line with the endorsed Client Managed Access strategy by product/indication, participate in the design of

Managed Access operational aspects.

Documentation & Compliance

- Develop, by product/indication, all Managed Access documentation (e.g. patient access form, order form,

informed consent form, HCP responsibilities).

- Ensure the electronic Document Management System (eDMS) for global Managed Access is kept up to date by

uploading and completing all required documentation and information, including safety-supporting evidence.

- Conduct regular quality reviews of global Managed Access documentation within the eDMS.

- Ensure all documentation and information are complete prior to closing global Managed Access programs.

Project Management & Governance

- Be responsible for global Managed Access plans, including timelines and budget.

- Monitor progress of global Managed Access programs against established timelines, budget, and deliverables;

escalate issues as needed and provide regular updates to internal stakeholders.

- Provide monthly status and performance updates of global Managed Access activities in the eDMS.

- Manage cross-functional activities across Client departments from program inception to completion.

Vendor & Stakeholder Management

- Be responsible for procurement activities related to global Managed Access vendor selection and contracting.

- Manage day-to-day operational relationships with global Managed Access vendors to ensure successful

execution and adherence to service level agreements.

- Liaise with internal stakeholders to ensure company strategy, targets, and standards are met.

Support, Training & Continuous Improvement

- Provide support to Managed Access initiatives and programs handled by affiliates.

- Support the Managed Access Director during audits and inspections related to Managed Access.

- Participate with the Managed Access Director in the training of Client employees on the Client Product Access

Request process.

- Contribute to the continuous improvement of Managed Access processes and documentation.