Title:
Project Manager, Epidemology/RWE Team

Company:
Ipsen Pharma (SAS)

About Ipsen:

Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation.

Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company's success. Join us on our journey towards sustainable growth, creating real impact on patients and society!

For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram.

Job Description:

Are you ready to lead and innovate in a dynamic, patient-focused biopharmaceutical company?

Ipsen is a growing global specialty-driven biopharmaceutical company focused on innovation and specialty care. We aim to make a sustainable difference by significantly improving patients' health and quality of life, providing effective therapeutic solutions for unmet medical needs through differentiated and innovative medicines in Oncology, Neurosciences, and Rare Diseases.

Why Ipsen?

• Patient-Focused: The patient is at the heart of everything we do, and improving their outcomes is the deliverable of every strategy.
• Employee Care: We care for our employees, who are the ambassadors making a real difference.
• Bold Leadership: We attract and develop bold, agile, entrepreneurial individuals who take full ownership of their decisions.
• Growth Opportunities: We offer a wealth of fulfilling challenges and growth opportunities in a fast-moving, game-changing organization.

About the Role:

The Project Manager (PM) plays a critical role in supporting the successful planning, execution, and documentation of Ipsen-sponsored studies on behalf of the Epidemiology, RWE & Evidence Strategy team within Global Medical Affairs.

You will:

• Work closely with the Study/Project Leads and cross-functional colleagues acting as the primary point of contact for project tracking, reporting processes, meeting coordination, and follow-up on action items.
• Provide high-quality project coordination and business administrative and documentation support to ensure studies are conducted in accordance with Ipsen processes, regulatory requirements, and quality standards.
• Be responsible for maintaining all study trackers, essential documentation, vendor coordination, ethical submission packages, and compliance activities throughout the study lifecycle.

This role is essential to the operational integrity and inspection readiness of Ipsen's interventional and real-world evidence studies managed by the Epi, RWE and Evidence Strategy team.

Key Responsibilities:

Study Documentation & eTMF Maintenance

• Maintain, update, and quality-check the Trial Master File (TMF/eTMF) in accordance with Ipsen SOPs, quality standards, and GCP.
• Track document status, ensure timely filing, and support ongoing QC and reconciliation activities.

Study and Evidence Generation Operations Support

• Provide administrative support to the Study Leads, including scheduling meetings, preparing agendas and minutes, tracking action items, and supporting cross-functional coordination.
• Support development and maintenance of project trackers (e.g., study milestones, site activation, monitoring, safety reporting).
• Support development and management of integrated evidence generation plans (IEGPs) and/or any associated IEGP tracking tools.

Vendor Coordination

• Assist in the exchange and tracking of documents related to CROs, central labs, technology vendors, and contracted service providers.
• Coordination with external vendors to align on project status, budget, meeting coordination, and actions follow-up, including monitoring project budgets and scope.
• Drive review and execution of contracts when applicable, including coordination with relevant internal stakeholder groups (Procurement, Legal, PV, etc.).

Regulatory & Ethics Support

• Coordinate preparation of submission packages to Ethics Committees and Institutional Review Boards (IRBs) under Study/project Lead oversight, as relevant.
• Ensure compliant handling of safety-related documentation, protocol amendments, and other regulated materials in alignment with Ipsen SOPs and the PM role definition.

Compliance, Quality & Inspection Readiness

• Ensure all PM activities conform to Ipsen SOPs, ICH-GCP, GDPR/HIPAA (if applicable), and corporate quality requirements, as relevant.
• Support study audits, inspections, and readiness activities through robust documentation control.
• Contribute to continuous improvement efforts for operational tools, processes, and templates.
• Comply with all laws, regulations and policies that govern the conduct of Ipsen U.S. staff.

Financial, Administrative & Logistics Support

• Assist with vendor invoice tracking, purchase order requests, budget trackers, and study-related administrative expenditures.
• Support study logistics such as meeting organization and study material requests.
• Coordination, collation and undertaking of transparency reporting consolidation for the team.
• Undertake a range of administrative tasks and other projects and activities as required.
• Serve as a back-up point of contact for the Study/Project Lead.

Qualifications:

• Bachelor's degree in life sciences, healthcare, pharmacy, public health, or related field preferred.
• Experience in clinical research, RWE, medical affairs, or related operations roles preferred (internships included)
• Experience working in pharmaceutical/biotech setting
• Understanding of clinical research principles, GCP, and study operations.
• Familiarity with TMF/eTMF systems and document management requirements.
• Strong organizational and tracking skills; ability to manage multiple tasks and deliverables.
• Proficiency in MS Office (Word, Excel, PowerPoint), SharePoint, and collaboration tools.
• Fluency in English

If you feel that this could be the right next step for you, we would be delighted to engage with your application.

Ipsen is committed to fostering a diverse and inclusive workplace where all employees feel valued and empowered. If you feel that this could be the right next step for you, we would be delighted to engage with your application.

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We are committed to creating a workplace where everyone feels heard, valued, and supported; where we embrace "The Real Us". The value we place on different perspectives and experiences drives our commitment to inclusion and equal opportunities. When we include diverse ways of thinking, we make more thoughtful decisions and discover more innovative solutions. Together we strive to better understand the communities we serve. This means we also want to help you perform at your best when applying for a role with us. If you require any adjustments or support during the application process, please let the recruitment team know. This information will be handled with care and will not affect the outcome of your application.