Title:
Stagiaire Clinical Operations
Company:
Ipsen Pharma (SAS)
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 https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram.
Job Description:
SUMMARY / PURPOSE OF THE POSITION
The Clinical Project Manager (CPM) is a Project Leader with the 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 then this is undertaking the activities personally and coordinating the deliverables of the internal CFT.
Associate Clinical Project Manager
Provides support to the CPM/SCPM and responsible for activities/task packages delegated to you for projects assigned and/or take accountable for own projects (smaller and/or less complex projects).
Senior Clinical Project Manager
Provide oversight of ACPM/CPM activities for assigned projects, provide mentorship and support to more junior CPMs, where assigned act as lead for full asset/portfolio of projects and provision of strategic Clinical Research Leadership input.
MAIN RESPONSIBILITIES / JOB EXPECTATIONS
Clinical Research Leadership
Senior Clinical Project Manager
- To work with internal stakeholders and Cross Functional Team to ensure excellence in execution of all evidence generation activities.
- To provide internal consultancy and thought leadership with regards to the conduct of clinical research.
- To design study synopses and develop research protocols aligned with integrated evidence generation plans (IEGP) that will support the study through Ipsen approval pathways.
- To 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 the preparation and development of the study protocol.
- Own preparation of the project budget including financial and clinical supply forecasting.
- Develop the 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 in collaboration with the CFT, Global Procurement and Corporate Legal Affairs.
- Co-ordinate completion of the study Integrated Oversight Plan (IOP) prior to initiation of the study defining and agreeing KPIs/QTLs/Performance indicators with SPs and the Cross Functional Team.
- Oversee SP performance and creation of documents required for the execution of the study.
- 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 co-ordination of investigator’s meetings)
- Complete posting of the study on external registries (clinicaltrials.gov etc) in compliance with Ipsen transparency requirements and regulatory commitments.
- Ensure (or Oversight of) that all necessary 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 the progress of the study and SP’s 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 as appropriate.
- If applicable liaise with Regional Clinical Operations team to execute any co-monitoring activities defined for SP oversight and/or set up regular meeting with MSLs (Medical Science Liaison) at LMA (Local Medical Affairs) who may be able to support Clinical Operations at various steps (site qualification, site recruitment).
- Proactively escalate deviations and non-compliances affecting the rights, wellbeing and safety of patients, adherence to the protocol or the ethical conduct of the study.
- Via leadership of the study team, provide end to end oversight of the data, to ensure delivery to defined protocol, timelines and quality, timely execution of data deliverables and subsequent delivery of excellence in execution.
- Recommend, review and oversee amendments to study protocol ensuring implementation at investigator sites following receipt of the 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 regular newsletters, ad hoc investigator meetings and motivational calls.
- Ensure that the CTMS is updated and that data in SMD is submission ready.
- Accountable for eTMF inspection readiness.
Study Completion
- Coordinate the preparation, the review and the submission of the CSR with Medical Writing.
- Ensure the finalization and archiving of the eTMF.
- Ensure that the study results are posted to the required registries.
- All necessary regulatory reporting requirements of the study results and end of study summaries are completed.
KNOWLEDGE, ABILITIES & EXPERIENCE
Senior CPM
- Significant and relevant experience of pharmaceutical drug development (Ph2, Ph3) including project management of national and international programs OR significant and relevant experience in RWE/HEOR, NIS studies, including project management of national and international programs.
Clinical Project Manager
- Relevant experience of pharmaceutical drug development (Ph2, Ph3) including project management of national and international programs OR significant and relevant experience in RWE/HEOR, NIS studies, including project management of national and international programs.
Associate Clinical Project Manager
- Background in pharmaceutical drug development (Ph2, Ph3) including project management of national and international programs OR significant and relevant experience in RWE/HEOR, NIS studies, including project management of national and international programs.
Additional Knowledge, Abilities & Experience
- Experience and know-how in Oncology or in Rare Diseases or in Neurosciences.
- Proven track record of delivery of projects to time, budget and quality.
- Extensive track-record of interactions with country Medical Affairs Staff is a 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 life science degree or Master’s degree or equivalent.
- Excellent oral and written English.
- Computer literacy.
- Ability to travel as required with the needs of the role, up to approximately 25% of the time.
Nous nous engageons à créer un lieu de travail où chacun se sent écouté, valorisé et soutenu, où nous incarnons « The Real Us*». La valeur que nous accordons aux différentes perspectives et expériences motive notre engagement en faveur de l'inclusion et de l'égalité des chances. Lorsque nous intégrons des modes de pensée diversifiés, nous prenons des décisions plus réfléchies et découvrons des solutions plus innovantes. Ensemble, nous nous efforçons de mieux comprendre les communautés que nous servons. Cela signifie que nous voulons également vous aider à donner le meilleur de vous-même lorsque vous postulez à un poste chez nous. Si vous avez besoin d'aménagements ou d'aide pendant le processus de candidature, veuillez en informer l'équipe de recrutement. Ces informations seront traitées avec soin et n'auront aucune incidence sur le résultat de votre candidature. *Soyons nous-même