Stage Clinical Operations

Join to apply for the Stage Clinical Operations role at Ipsen Job Title: Associate Clinical Project Manager, Clinical Project Manager, Senior Clinical Project Manager Division / Function: Global Medical Clinical Operations Manager (Name, Job Title): Therapeutic Area Head – GM Clinical Operations Location: Hub Summary / Purpose of the Position The Clinical Project Manager (CPM) is a Project Leader with end‑to‑end accountability for the successful execution of global Evidence Generation activities including but not limited to interventional and non‑interventional Company Sponsored Studies (CSS), Research with Secondary Use Data (SUD), and other assigned medical affairs projects falling within the remit of GM Clinical Operations. The CPM has responsibility for planning, initiation, conduct and reporting for all assigned evidence generation projects ensuring completion to budget and within timelines according to the relevant GXP regulations, external guidelines, SOPs and quality standards. Where activities are outsourced this means oversight of the Service Provider (SP) and co‑ordination of internal cross‑functional team (CFT). If in‑house, the CPM personally undertakes the activities and coordinates the deliverables of the internal CFT. Associate Clinical Project Manager – Provides support to the CPM/SCPM and is responsible for activities/task packages delegated to the individual for projects assigned and/or takes accountability for own smaller or less complex projects. Senior Clinical Project Manager – Provides oversight of ACPM/CPM activities for assigned projects, mentors and supports more junior CPMs, acts as lead for full asset/portfolio of projects, and provides strategic Clinical Research Leadership input. Main Responsibilities / Job Expectations Clinical Research Leadership (Senior Clinical Project Manager) Work with internal stakeholders and Cross Functional Team to ensure excellence in execution of all evidence generation activities. Provide internal consultancy and thought leadership with regard to the conduct of clinical research. Design study synopses and develop research protocols aligned with integrated evidence generation plans (IEGP) that support the study through Ipsen approval pathways. Consult with key opinion leaders and external stakeholders to develop studies relevant to patients and the clinical community. Preparation of the study Set‑up and lead the study Cross Functional Team (CFT) overseeing study design and kick‑off activities. Initiate high‑level feasibility and continuously monitor how changes to the study design affect feasibility during protocol development. Own preparation of the project budget including financial and clinical supply forecasting. Develop study timelines planning for critical events and milestones as agreed by the Cross Functional Team. Drive excellence in execution and adherence to the project plan through application of project management best practices. Liaise with Global Patients Affairs to embed patient centricity into study conduct and the design of Ipsen evidence generation activities. Maintain awareness of digital opportunities through collaborative work with the DIGS and data strategy teams. Establish close working relationships with Lead Medical Experts, Global Regulatory Affairs and Global Pharmacovigilance to support the submission and approval of PASS/PAES protocols to regulatory bodies such as EMA’s PRAC, the FDA, regional and local regulatory authorities. Initiation of the study Lead the SP selection process (RFP creation, bid defense, contracting) and collaborate with the CFT, Global Procurement and Corporate Legal Affairs. Coordinate completion of the study Integrated Oversight Plan (IOP) prior to initiation, defining and agreeing KPIs/QTLs/Performance indicators with SPs and the Cross Functional Team. Oversee SP performance and creation of documents required for study execution. Identify and select investigator sites in collaboration with the Medical Asset Lead, SP and Ipsen Affiliates. Coordinate the set‑up of the eTMF (Trial Master File) in collaboration with the CTA assigned to the study. Ensure that the study CFT and investigator sites are appropriately trained (e.g., oversight of or creation and approval of investigator training materials, completion and coordination of investigator meetings). Complete posting of the study on external registries (clinicaltrials.gov, etc.) in compliance with Ipsen transparency requirements and regulatory commitments. Ensure regulatory, ethical, IRB and governance approvals are in place prior to commencement of recruitment at an investigator site. Study Conduct Coordinate the CFT (internal and SPs) overseeing study progress and SP performance to ensure timely on‑budget delivery. Monitor execution and delivery of KPIs/QTLs/Performance indicators as agreed in the IOP. If applicable for projects assigned, review site visit reports per the IOP, ensuring timely and appropriate follow‑up of issues raised by monitors, cross‑functional team members, affiliates and/or CROs. Liaise with Regional Clinical Operations team to execute any co‑monitoring activities defined for SP oversight and/or set up regular meetings with MSLs (Medical Science Liaison) at LMA who may support Clinical Operations at various steps (site qualification, site recruitment). Proactively elevate deviations and non‑compliances affecting patient rights, wellbeing and safety, adherence to the protocol or ethical conduct of the study. Lead the study team to provide end‑to‑end oversight of data, ensuring delivery to defined protocol, timelines, quality, and timely execution of data deliverables and overall excellence. Recommend, review and oversee amendments to study protocol ensuring implementation at investigator sites following necessary approvals. Provide and present regular reports on study progress including site performance, data quality and resource needs. Undertake activities to inform and motivate investigators and the study team through appropriate engagement activities (e.g., distribution of newsletters, investigator meetings, motivational calls). Ensure the CTMS is updated and data in SMD is submission ready. Accountable for eTMF inspection readiness. Study Completion Coordinate preparation, review and submission of the CSR with Medical Writing. Ensure the finalization and archiving of the eTMF. Ensure study results are posted to required registries. Complete all necessary regulatory reporting requirements of the study results and end‑of‑study summaries. Knowledge, Abilities & Experience Senior CPM: Significant and relevant experience of pharmaceutical drug development (Phase 2, Phase 3), including project management of national and international programs, or significant experience in RWE/HEOR, NIS studies. Clinical Project Manager: Relevant experience in drug development (Phase 2, Phase 3) or RWE/HEOR, NIS studies, with national and international program management. Associate Clinical Project Manager: Background in drug development (Phase 2, Phase 3) or RWE/HEOR, NIS studies, with national and international program management. Experience and know‑how in Oncology, Rare Diseases or Neurosciences. Proven track record of delivery of projects on time, budget and quality. Extensive track‑record of interactions with country Medical Affairs Staff (significant plus). Intimate knowledge of Good Clinical Practice (GCP) for CPMs managing interventional CSS and non‑GCP data regeneration regulations for CPMs managing NIS and research with SUD. Senior CPM: Recent, significant and successful experience in mentoring people. Experience of working with multidisciplinary groups and ability to work within a team environment. Experience of managing and developing relationships with Service Providers. Excellent organisational and management skills. Excellent verbal and written communication skills. Bachelor’s or Master’s degree in life sciences or equivalent. Excellent oral and written English. Computer literacy. Ability to travel as required, up to approximately 25 % of the time. Seniority level Not Applicable Employment type Full‑time Job function Research, Analyst, and Information Technology Industries Pharmaceutical Manufacturing #J-18808-Ljbffr