Senior Clinical Project Manager

Title: Senior Clinical Project Manager Company: Ipsen Bioscience, Inc. Job Description: Sr. Clinical Project Manager Purpose of the position Sr. 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 medical/clinical 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 team He/she is responsible for the external and internal stakeholder management in outsourcing/CRO model and an asset centric internal environment He/she 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 external/CRO 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 Ipsen/CRO SOPs Sr. CPM could manage a complex Ph2/3 program or multiple studies at various stages of conduct (e.g.,Global Ph1 & Ph2/Ph3 study at the same time or a very complex Ph2/3 global study) Main responsibilities and tasks Contribute to study protocol development including study concept, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate, where applicable Works closely with the CPD/Sr. CPD and cross-functional team members to develop and outline study plans, timelines and costs Provide expertise to clinical outsourcing specifications and purchasing to facilitate RFP documents and selection of Services Provider Lead 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 CPD/Sr. 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 asset/clinical strategy Accountable 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 closely Monitors resource utilization over the study life cycle Ensure 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 members Leads country feasibility and site selection processes in collaboration with Sr CPD/CPD, Medics and CRO. Seeks input where necessary from Ipsen Affiliates, to identify high quality investigators and study sites Ensures timely availability of high-quality study documents to allow study submission to regulatory authorities and ECs/IRBs Provides oversight to study start up, site contract/budget negotiations and site activation plans to ensure we stay on track to the projected study start-up timelines Provides support and oversee the activities of the Clinical Trial Associate (CTA) and Clinical Monitoring Lead (CML) assigned to the study per SOPs and job descriptions Works 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 Closely tracks the recruitment on the study and ensures all strategies are implemented to keep recruitment on track Work 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 ICH/GCP 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 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 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 Collaborates 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 sites Ensures 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 systems Participates 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 filed Ensures Trial Master File for study is created, maintained and QC'd on a regular basis as per the study TMF QC plan Ensures all study conduct activities are occurring on-time and per plans Supports 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 results Ensures planning and execution of the Clinical Study Report in collaboration with Medical Writing and relevant CST members 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 SP Assist Quality Assurance 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 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 implemented Prepares team for quality assurance audits and inspections Collaborates with Clinical Study Team members and other colleagues to ensure cross-team, site learnings, and best practices are shared Mentors more junior team members and might take on line management responsibilities as required Establish 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 Clinical activities (out of studies) Contribute/participate on SOP update and review training material created by Process Training Management Contribute 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 projects Interact with CPD to define strategic operational direction Review status reports provided by Service Provider/CRO and highlight issues to facilitate decision making Manage 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 EHS responsibilities: Comply with applicable EHS regulations and procedures. Participate in the site's EHS performance by reporting risks, malfunctions or improvements Participate in mandatory EHS training Experience / Qualifications Experience: 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 yrs Experience in leading global cross-functional clinical study teams Experience in managing and developing relationships with Contract Research Organizations (CROs/SPs) Strong understanding of FDA, EMEA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies Experience in working with multidisciplinary groups (internal & external), flexibility, adaptability and ability skills to work within a matrix environment Experience across multiple therapeutic areas and managing complex Ph1-3 trials Experience in outlining clinical study operational strategies and managing de-centralized studies Qualification: Life science or medical graduate or other relevant qualifications. Language: English: Very good English language knowledge (oral and written) The annual base salary range for this position is $171,900 - $210.100. This job is eligible to participate in our short-term incentives program as well as our long-term incentives program. At 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. The 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. 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 identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

Created: 2025-03-11