Senior Clinical Project Manager (Remote-Based)

Cookie Notice Title: Senior Clinical Project Manager (Remote-Based) Company: Ipsen Biopharmaceuticals Inc. 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 and follow our latest news on and . Job Description: WHAT - Summary & Purpose of the Position The Senior Clinical Project Manager is responsible for the execution and oversight of global clinical trials outsourced to CROs, ensuring alignment with timelines, quality standards, budgets, and study goals. This role collaborates closely with Clinical Development Program Directors (CDPDs), Medical Development Directors (MDDs), and other Ipsen team members to drive study activities and report progress. The manager endorses CRO-developed project plans, ensuring they meet Ipsen's requirements for team responsibilities, risk mitigation, escalation processes, communication strategies, and performance and quality tracking. They also ensure that studies comply with Good Clinical Practice (GCP), local regulations, and internal SOPs.In addition to managing study budgets and maintaining accurate data across tracking systems, the Senior Clinical Project Manager leads, manages, and drives the cross-functional Clinical Study Team and external partners, including CROs and service providers. The role fosters effective collaboration with all stakeholders to ensure high-quality execution. Furthermore, the manager contributes to innovation by identifying opportunities for process or technology improvements and actively participating in continuous improvement initiatives. Ensure study team management and communication: + Oversee and drive cross-functional leadership and expertise to ensure effective contribution, execution and delivery of study activities as per quality, plan/timelines and budget for one study or more within a clinical program + As directed by Line manager, manage, coach and develop some Clinical Operation team members assigned to the study or program + Foster a team approach to all activities associated with the implementation, conduct and closing of clinical studies including Ipsen clinical study team members (TA, Biometry, Pharmacovigilance, Finance controlling, Global Regulatory Affairs, CMC Supply chain ) and CROs + Establish and maintain excellent professional relationships with Services Providers / CROs, clinical study team through regular communication, between company, investigators and experts in conjunction with + Medical Dev. Director (MDD) and other relevant Ipsen team members Lead clinical project processes: + Support the CDPD and collaborate closely to define study or program strategic direction and might represent the CDPD to project or asset team meetings, as needed + Lead cross-functional clinical study teams focused on conduct of assigned projects + Review and analyse status reports provided by Service Provider/CRO and highlight issues to facilitate decision making and escalate as required + Manage and lead all operational aspects for implementation and conduct of global clinical trial activities from study feasibility to CSR, in respect of GCPs, Regulatory requirements and relevant SOPs Key accountabilities and activities: + Set-up study team before Services Provider / CRO are on board and lead and manage regular internal Study Team meetings during the course of the study. + Contribute to study protocol development including study concept where applicable + Develop and control planning and study timelines in collaboration with all other Ipsen supportive functions/CRO + Provide expertise to clinical outsourcing specifications and purchasing to facilitate RFP documents and selection of Services Provider/CRO + Participate in the selection of Services Providers /CROs and other external vendors in collaboration with purchasing department, study team and Corporate Legal Affairs + Accountable for the development, management and tracking of trial budget working closely with the finances and service provider representative - financial management of the clinical trial including budget planning and preparation of quarterly reports + Ensure appropriate oversight of Services Providers /CRO(s) and other external vendors activities and develop the oversight manual in accordance with the services providers Technical Specifications document + Review final draft and approve major study documents as described in the Services Providers /CROs Technical Specification documents (e.g. oversight manual, communication plan, project plan, instruction manuals .) + Supervise country feasibility and site selection processes in collaboration with CDPD, MDD, GMA, CRO and Ipsen Affiliates (if needed) to identify and gain approval for high quality investigators and study sites + Provide support and oversee the activities of the Clinical Trial Assistant (CTA) assigned to the study for: insurance certificate, contracts signature process, set-up and management of the Trial Master File (eTMF), transparency and local reporting as per legal and Ipsen requirements, update of reporting tools (study trackers, Hermes, etc.) and alert if required; drive billing and forecast + As applicable, provide support and oversee the activities of the Clinical Monitoring Lead (CL) to ensure the coordination of the clinical, monitoring and site management activities are in accordance with study objectives and quality standards. + Work with the CRO, Patient Affairs office, and digital team as appropriate to develop and approve a recruitment strategy and communication tools (e.g. Newsletter ) to increase study awareness, patient recruitment and retention in the study + Ensure through study team management that the necessary regulatory, safety and data evaluation requirements are met to allow the conduct of clinical related activities in conjunction with the Regulatory, Pharmacovigilance (GPS), Data Management and Statistics Departments + Participate in meetings lead by CRO (e.g. Inv. & CRA meeting, Study team meeting, Clinical Data Review ), Review meeting minutes and ensure with CRO Project Manager that issues are proactively identified, communicated and resolved in a timely manner + Ensure timely and accurate completion of project milestones, study progress tools (planning reporting, study dashboard ) and escalate appropriately in case of deviation to the planning and of any issue regarding the quality of the data + Travel as needed to observe and discuss projects, build positive working relationships and maintain enthusiasm regarding projects + For activities, not outsourced (e.g. Management of IMP ) ensure regular forecast update and bulk shipment + Work with line functions and Quality Assurance (GRDQ) to identify potential quality issues. Coordinate post quality audit hosted by Sponsor and ensure CAPA implementation by CRO + Assist Quality Assurance (GDDQ) within inspections preparation as applicable + Participate in the preparation and review of clinical study reports and ensure that CSR Appendices are completed and validated by the relevant functions within the agreed timelines. + Liaise with the relevant Ipsen