{"id":965484,"url":"https://alion.io/job/ipsen-clinical-project-manager","title":"Clinical Project Manager","company":{"id":5773,"name":"Ipsen","domain":"ipsen.com","url":"https://alion.io/company/ipsen","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":86,"open_postings":24,"ghost_share":0,"stale_share":0.542,"repost_share":0,"time_to_fill_p50_days":52,"computed_at":"2026-11-07T05:47:08Z"}},"role":"Management","role_family":"Management","seniority":"middle","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Cambridge, United States","London, United Kingdom"],"countries":["US","GB"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":144000,"max":200000,"currency":"USD","period":"year","gross":null,"usd_annual":200000},"salary_estimate":null,"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GCP","optional":false}],"status":"live","first_seen_at":"2026-09-16T13:59:21Z","employer_posted_date":"2026-09-16","last_verified_at":"2026-11-07T20:16:43Z","board_verified":true,"closed_at":null,"days_open":52,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":52},"description":"Title:\nClinical Project ManagerCompany:\nIpsen Biopharmaceuticals Inc.About Ipsen:\nIpsen 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.\nOur 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!\nFor more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram.\nJob Description:\n\nLead, Manage and Drive the cross-functional Clinical Study Team and Contract Research Organization (CRO) in collaboration with the CDPDs and Ipsen team members responsible of the study\nResponsibilities include, but are not limited to the following:\nEnsure study team management and communication:\nOversee and drive cross-functional leadership and expertise to ensure effective contribution, execution, and delivery of study activities as per quality, plan/timelines, and budget.\nFoster 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 SPs.\nEstablish and maintain excellent professional relationships with Services Providers, clinical study team through regular communication, between company, investigators, and experts in conjunction with Medical Dev. Director (MDD) and other relevant Ipsen team members.\nLead clinical project processes:\nLead cross-functional clinical study teams focused on conduct of assigned projects.\nInteract with CDPD to define strategic operational direction.\nReview status reports provided by Service Provider/CRO and highlight issues to facilitate decision making.\nManage and lead all operational aspects for implementation and conduct of global clinical trial activities from study start-up to CSR, in respect of GCPs and relevant SOPs.\nKey accountabilities and activities:\nDevelop, manage, and execute assigned projects by:\nSet-up study team before Services Provider are on board and lead and manage regular internal Study Team meetings during the course of the study.\nContribute to study protocol development including study concept where applicable.\nDevelop and control planning and study timelines in collaboration with all other Ipsen supportive functions/SPs.\nProvide expertise to clinical outsourcing specifications and purchasing to facilitate RFP documents and selection of Services Provider\nParticipate in the selection of Services Providers and other external vendors in collaboration with purchasing department, study team, finance controller and Corporate Legal Affairs\nAccountable 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.\nEnsure appropriate oversight of Services Providers) and other external vendors activities and develop the oversight manual in accordance with the services providers Technical Specifications document.\nReview 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….)\nSupervise 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.\nProvide support and oversee the activities of the Clinical Trial Associate (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,…) and alert if required; drive billing and forecast\nAs applicable, provide support and oversee the activities of the Clinical Monitoring Lead (CML) to ensure the coordination of the clinical, monitoring and site management activities are in accordance with study objectives and quality standards.\nWork with the SP, 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.\nEnsure 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\nParticipate in meetings lead by SP (e.g. Inv. & CRA meeting, Study team meeting, Clinical Data Review …), Review meeting minutes and ensure with SP Project Manager that issues are proactively identified, communicated and resolved in a timely manner.\nEnsure 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.\nTravel as needed to observe and discuss projects, build positive working relationships, and maintain enthusiasm regarding projects.\nFor activities, not outsourced (e.g., Management of IMP…) ensure regular forecast update and bulk shipment.\nWork with line functions and Quality Assurance (GRDQ) to identify potential quality issues. Coordinate post quality audit hosted by Sponsor and ensure CAPA implementation by SP.\nAssist Quality Assurance (GDDQ) within inspections preparation as applicable.\nParticipate in the preparation, review of clinical study reports, and ensure that CSR Appendices are completed and validated by the relevant functions within the agreed timelines.\nLiaise with the relevant Ipsen or Service Providers teams to ensure the posting of the clinical study and the results on the required registries and as per local regulations.\nTo perform any other activity as may reasonably be required by the DCDP and/or TA clinical operation head from time to time.\nClinical Activities (out of studies):\nContribute/participate on SOP update and review training material created by Process Training Management\nContribute to the efficient operation of the TA Group and to transversal project cross- TAs and other departments within Ipsen (e.g., systems implementation, change management initiatives, continuous improvement initiatives …)\nEHS Responsibilities:\nComply with applicable EHS regulations and procedures.\nParticipate in the site's EHS performance by reporting risks, malfunctions, or improvements.\nParticipate in mandatory EHS training\nEducation / Certifications:\nBachelor’s degree in life science or medical graduate preferred, or relevant qualifications.\nExperience:\nRelevant experience of pharmaceutical drug development:\nMinimum of 3 years working in clinical research with management of clinical activities for the set up and running of international registrational studies, for at least 2 years.\nExperience in managing and developing relationships with Contract Research Organizations (CROs/SPs)\nExperience in working with multidisciplinary groups (internal & external), flexibility, adaptability, and ability skills to work within a matrix environment.\n Fluent English\nAbility to work in a strong regulated environment within a quality management system (QMS)\nAdvanced knowledge of software application (ex: Word, Excel, PowerPoint, Adobe Reader …)\nAbility to organize and prioritize.\nAble to produce work in teams and within a multi-disciplinary environment.\nBasic Financial Knowledge- must be able to work with financial tracking tools.\nKnowledge of Pharmaceutical Industry R&D\nGood understanding of the drug development process and knowledge of the pharmaceutical industry environment\nGood knowledge of the Good Clinical Practices (GCP) or other clinical study regulations\nIntimate knowledge of regulatory requirement (ICH E6, GCP, EU Directive)\nExcellent leadership skills and capability to work within a team as leader and team player.\nExcellent organizational and management skills\nStrong verbal and written communication skills (English)\nCompensation\nThe annual base salary range for this position is $144,000 - $200,000.\nThe pay range displayed above is the range of base pay compensation within which Ipsen expects to pay for this role at the time of this posting. Individual compensation within this range depends on a variety of factors, including, but not limited to, prior education and experience, job-related knowledge and demonstrated skills.\nThis job is eligible to participate in our incentive compensation program as well as our long-term incentives program.\nAt Ipsen we are proud to offer a comprehensive employee benefits package, including 401(k) with company contributions, group medical, dental and vision coverage, life and disability insurance, short- and long-term disability insurance, as well as flexible spending accounts. Ipsen also provides parental leave, paid time off, a discretionary winter shutdown, well-being allowance, commuter benefits, and much more.\nWe 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. Ipsen is an equal opportunity employer that strictly prohibits unlawful discrimination. 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