Senior Clinical Project Manager

Title:Senior Clinical Project ManagerCompany:Ipsen Bioscience, Inc.Job Description:Job title: Sr. Clinical Project ManagerDepartment: Clinical Development Operations, R&DLine Manager: (Senior) Director Clinical Program Director (CPD)Location of the role: UK (London) or France (Les Ulis) or USA (Cambridge)Purpose of the positionSr. Clinical Project Manager(CPM) is accountable for the delivery of assigned clinical study on-time, within budget and quality. The CPM has full ownership within the clinical study team and as such will be leading and partnering with medicalclinical development, medical writing, data management, biostatistics, PV on the protocol and other study activities and ensure alignment with the asset teams and strategy.Provides leadership and guidance to the cross-functional clinical study teamHeshe is responsible for the external and internal stakeholder management in outsourcingCRO model and an asset centric internal environmentHeshe will partner cross-functionally with purchasing and finance to drive RFP process and select appropriate partners for study(ies) in scope and manage and drive cross-functional and externalCRO teams to ensure full roll-out and timely execution of the study project plans according to the outlined strategy, scope and following the ICH GCP guidelines and IpsenCRO SOPsSr. CPM could manage a complex Ph23 program or multiple studies at various stages of conduct (e.g.,Global Ph1 & Ph2Ph3 study at the same time or a very complex Ph23 global study)Main responsibilities and tasksContribute to study protocol development including study concept, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate, where applicableWorks closely with the CPDSr. CPD and cross-functional team members to develop and outline study plans, timelines and costsProvide expertise to clinical outsourcing specifications and purchasing to facilitate RFP documents and selection of Services ProviderLead the selection of Services Providers (SPs) and other external vendors in collaboration with purchasing department, cross-functional study team, finance controller and Legal Affairs. Outline the assumptions document for the RFI RFP template, participate and drive the BID defense meetings and track responses to the questions. Work closely with the CPDSr. CPD and clinical study team to select the final CRO, finalize the SOW and budgets for the study. Ensure that the strategy outlined by the CRO is aligned with the assetclinical strategyAccountable for the development, management and tracking of trial budget working closely with the finance and SP representative. Ensure that the clinical study stays on-track within the budget approved at governance. Tracks the changer orders closelyMonitors resource utilization over the study life cycleEnsure appropriate oversight of Services Providers and other external vendors activities and develop the oversight plan in accordance with Ipsen SOP ,the operational assumptions and scope of work of the SP contract(s) Review final draft and approve all study plans, documents per applicable SOPs (e.g. oversight manual, communication plan, project plan, Vendor manuals, instruction manuals, monitoring plans, Medical monitoring plan, DM plan, TMF plan etc....) Facilitates reviews and maintenance of these critical plans with cross-functional team membersLeads country feasibility and site selection processes in collaboration with Sr CPDCPD, Medics and CRO. Seeks input where necessary from Ipsen Affiliates, to identify high quality investigators and study sitesEnsures timely availability of high-quality study documents to allow study submission to regulatory authorities and ECsIRBsProvides oversight to study start up, site contractbudget negotiations and site activation plans to ensure we stay on track to the projected study start-up timelinesProvides support and oversee the activities of the Clinical Trial Associate (CTA) and Clinical Monitoring Lead (CML) assigned to the study per SOPs and job descriptionsWorks 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 studyClosely tracks the recruitment on the study and ensures all strategies are implemented to keep recruitment on trackWork closely with the Medics, DM, CML and CROs to ensure eligible patients are enrolled into the study and site is conducting all activities in accordance to the ICHGCPEnsure 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 DepartmentsParticipate 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 mannerEnsure 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 dataCollaborates closely with Global Clinical Supplies to forecast study drug and timely delivery of supplies to sites. Has close oversight on the clinical supplies inventory to ensure that enough supplies are maintained in the local country depot and at sitesEnsures study systems and tools are set up timely, correctly and are functioning properly. Ensures study level information is updated on an ongoing basis in all systemsParticipates in UAT for relevant systems for the study (e.g., IVRS, eCRF, ePROs etc)Ensures relevant study specific training is developed and implemented and ensures training records are well documented and filedEnsures Trial Master File for study is created, maintained and QC'd on a regular basis as per the study TMF QC planEnsures all study conduct activities are occurring on-time and per plansSupports and as needed drives overall data cleaning timelines in close collaboration with CROs, CML, Data Management and other stakeholders (e.g., MDDs, Safety collegues etc)Ensures all activities are completed in time for data base lock and final study resultsEnsures planning and execution of the Clinical Study Report in collaboration with Medical Writing and relevant CST membersWork with line functions and Quality Assurance (GRDQ) to identify potential quality issues. Coordinate post quality audit hosted by Sponsor and ensure CAPA implementation by SPAssist Quality Assurance within inspections preparation as applicableParticipate 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 or Service Providers teams to ensure the posting of the clinical study and the results on the required registries and as per local regulations.Ensures senior management and other key stakeholders are informed of risks and challenges and ensures risk mitigation plans are put in place and implementedPrepares team for quality assurance audits and inspectionsCollaborates with Clinical Study Team members and other colleagues to ensure cross-team, site learnings, and best practices are sharedMentors more junior team members and might take on line management responsibilities as requiredEstablish 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 membersClinical activities (out of studies)Contributeparticipate on SOP update and review training material created by Process Training ManagementContribute 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 ...)Ensure study team management and communication Lead cross-functional clinical study teams focused on conduct of assigned projectsInteract with CPD to define strategic operational directionReview status reports provided by Service ProviderCRO and highlight issues to facilitate decision makingManage 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 SOPsEHS responsibilities:Comply with applicable EHS regulations and procedures.Participate in the site's EHS performance by reporting risks, malfunctions or improvementsParticipate in mandatory EHS trainingExperience QualificationsExperience:Relevant experience of pharmaceutical drug development:Minimum of 5-7 years working in clinical research with management of clinical activities for the set up and running of global registrational studies, for at least 3 years. For Sr. CPM role needs to have experience managing global clinical studies for at least 5-7 yrsExperience in leading global cross-functional clinical study teamsExperience in managing and developing relationships with Contract Research Organizations (CROsSPs)Strong understanding of FDA, EMEA and ICH GCP guidelines to ensure the appropriate conduct of clinical studiesExperience in working with multidisciplinary groups (internal & external), flexibility, adaptability and ability skills to work within a matrix environmentExperience across multiple therapeutic areas and managing complex Ph1-3 trialsExperience in outlining clinical study operational strategies and managing de-centralized studiesQualification: Life science or medical graduate or other relevant qualifications.Language: English: Very good English language knowledge (oral and written)IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identityexpression, national originancestry, age, mentalphysical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

Created: 2025-02-22