Clinical Project Manager

Overview

In this role you lead and coordinate a cross-functional clinical study team and external CROs to deliver global trials on time, within quality, and on budget. You’ll partner with MDD, SPs, and Ipsen functions to drive studies from start-up to CSR, shaping trial strategies and operations. You’ll manage outsourcing, budgeting, and regulatory alignment while fostering strong relationships with investigators and vendors. This position offers impact across programs and a hands-on role in trial execution and process improvement. You will play a key part in advancing Ipsen’s mission to bring transformative medicines to patients.

Pay / Benefits

• 401(k) with company contributions
• group medical, dental, and vision
• life and disability insurance
• paid time off
• parenteral leave and family benefits
• well-being allowance and commuter benefits

Responsibilities

• Lead cross-functional clinical study teams and CROs/SPs to ensure timely, quality delivery within budget
• Coordinate study start-up, execution, and close-out activities from protocol development to CSR
• Develop and control study timelines and budgets with Ipsen functions and SPs
• Oversee vendor selection, RFP processes, and contract negotiations in collaboration with Purchasing and Legal
• Monitor study progress, escalate issues, and drive decision-making with CDPD and MDD
• Support patient recruitment strategies and site management with SPs and teams
• Ensure regulatory, safety, and data governance requirements (GCP, SOPs, ICH/GCP) are met
• Prepare and review study documents, oversights and trial master file management (eTMF)
• Maintain quality assurance through CAPA follow-up with SPs and QA teams
• Communicate effectively with investigators, sites, and internal stakeholders
• Travel as needed to sites and meetings to ensure project momentum
• Manage internal study team meetings and coordination with SPs for ongoing visibility and alignment
• Support post-study activities including CSRs and registry postings as required
• Contribute to SOP updates and training materials for Process Training Management
• Assist in budget forecasting and financial reporting for trials

Key requirements

• Minimum 3 years in clinical research with management of international registrational studies (2+ years in management)
• Experience managing relationships with CROs/SPs
• Ability to work in a matrix, multidisciplinary environment
• Fluent English
• Strong understanding of GCP and regulatory requirements (ICH E6, EU Directive)
• Advanced knowledge of Word, Excel, PowerPoint, Adobe Reader
• Strong leadership and organizational skills
• Good verbal/written communication in English
• Basic financial literacy and experience with budget tracking tools

• leadership
• cross-functional collaboration
• communication
• GCP knowledge
• ICH E6 and EU Directive compliance
• budgeting and financial tracking

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