Project Manager, EpidemiologyRWE Team 1 year FTC CDD 1 an

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 companys success. Join us on our journey towards sustainable growth creating real impact on patients and society!

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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 crossfunctional 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 Ipsens interventional and realworld evidence studies managed by the Epi RWE and Evidence Strategy team.

Key Responsibilities:

Study Documentation & eTMF Maintenance

• Maintain update and qualitycheck 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 crossfunctional 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 safetyrelated 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 ICHGCP 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 studyrelated 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:

• Bachelors 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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