Senior Clinical Monitoring Lead

Il y a 2 mois

Les Ulis, France Ipsen Innovation (SAS) Temps plein

The Senior Clinical Monitoring lead is fully accountable for all clinical monitoring activities, overseeing the CRO clinical /site management activities and co-monitoring the assigned international Phase I to III clinical studies in accordance with GCP guidelines and regulations.
- He/she builds strong relationships with investigators and proactively acts as a site engagement lead and an Ipsen Ambassador.
- The Senior CML coordinates the achievement of assigned clinical study deliverables within a matrix organization in close collaboration with the Clinical Project Manager.
- The Senior CML, as requested, will act as CML lead for complex studies that involve several CMLs providing oversight in alignment with the Clinical Project Manager and Clinical Program Director.
- Sr. CML will mentor, coach other CMLs in the CDO organization and also work on transversal initiatives and process improvement.

**clinical study set up activities coordination & oversight responsibilities**:

- Ensure efficient and thorough study feasibility, either directly if internally managed, or by overseeing the Clinical team of the CROs and working closely with other relevant team members involved in the study feasibility (MDD, Reg, digital etc ): ensure feasibility assessment is appropriately managed and reports are exhaustive. Prepare or Review site feasibility reports as per oversight plan, as applicable, to ensure appropriate strategy is in place for the country/site selection for the success of the study in collaboration with the CPM/Clinical Program Director and ensure validation of the study feasibility report by the TA CDO head
- Ensure efficient and thorough study start-up, either directly if internally managed, or by overseeing the Clinical team of the CROs and working closely cross-functionally with other relevant team members involved in the study set up (DM, Reg, CMC etc ): Verify timely collection of essential study documents, such as regulatory and ethics committee documents for submission, oversee site Clinical Trial Agreements preparation and control that all set up activities are pro-actively managed and performed prior to each site initiation, as per the oversight plan.
- Ensure timely site contract negotiation and compliance of the site budget per agreed fair market value (FMV) at country level, including site overheads and patients stipends and compensation
- Contribute to establish the participant recruitment strategy to ensure materials are developed and submitted to IRBs/ECs (local/central advertising), contract with site include correct languages and adequate fees (referral network, participation to sponsor & sites calls)
- Support and ensure that all specific Ipsen/CRO EDC and/or eCOA system tasks under the clinical responsibility are completed and achieved according to the defined timelines without jeopardising the start of a trial (Participate in the development of the eCRFs, eCOA, randomization and supplies workflow set up and participate in the UAT activities for all systems involved, as applicable)
- Responsible for reviewing the CRA training material and site facing materials (eg.,Protocol training, study manuals, vendor manuals etc) and coordinating the review of such documents to the other study team members as applicable (DM, CMC, MDD etc ). Validate the final clinical study documents (such as patient facing documents, study manual, monitoring plan) prepared by the Clinical CRO, as per the oversight plan.
- Ensure CRO CRAs are appropriately trained to study protocol and support the Clinical CRO in the training of the CRAs on all study specific operational activities and participate in the organisation and preparation of the monitor and investigator meetings in collaboration with the other study team members (Corporate and/or affiliates, CROs as appropriate)
- Assist the CPM/ study team in the evaluation of detailed timelines and establishment of clinical studies milestones for assigned projects, ensuring that they are performed to the most rigorous standards of quality and timely delivery.
- Participate in the RFP process to review the assumptions going into monitoring activities. Collaboration with the CPM in the RFP process and participation to BID defense meeting
- Participate to the preparation of the internal Oversight Plan and review/comment associated documents managed by the CRO that are necessary to oversee the clinical activity implementation, monitoring and reporting in a professional, high quality and timely manner (such as monitoring oversight plan, data cleaning plan and clinical monitoring metrics ).
- Customize site Key Risk/Performance Indicator template and follow these KRIs/KPIs at frequency agreed in the oversight plan
- Ensure site initiation visits are occurring as planned.
- If applicable to set up regular meeting with MSL (Medical Science Liaison) at LMA (Local Medical Affairs) who can support Clinical Operations during start-up phase to discuss any potential sites we should c

  • Clinical Monitoring Lead

    Il y a 6 mois

    Les Ulis, France Ipsen Innovation (SAS) Temps plein

    **Purpose of the position** - Take responsibility for coordinating the clinical monitoring activities, overseeing the CRO clinical /site management activities and co-monitoring the assigned international Ph2/3 clinical studies in accordance with regulatory requirements, Good Clinical Practice (GCP) guidelines and SOPs to the most rigorous standards of...

  • Clinical Monitoring Lead

    Il y a 5 mois

    Les Ulis, France Ipsen Innovation (SAS) Temps plein

    Please send your CV in English ! **Purpose of the position** - Take responsibility for coordinating the clinical monitoring activities, overseeing the CRO clinical /site management activities and co-monitoring the assigned international Ph2/3 clinical studies in accordance with regulatory requirements, Good Clinical Practice (GCP) guidelines and SOPs to the...

  • Global Clinical Monitoring Lead F/m

    il y a 4 semaines

    Les Ulis, France Ipsen Innovation (SAS) Temps plein

    **Main responsabilities** Ensure clinical activities coordination & oversight: - Ensure efficient and thorough study start-up by overseeing the Clinical team of the CROs and working closely with other relevant team members involved in the study set up (DM, Reg, CMC etc ): to verify timely collection of essential study documents, such as regulatory and...

  • Clinical Scientist

    Il y a 5 mois

    Les Ulis, France Ipsen Innovation (SAS) Temps plein

    **Summary / purpose of the position** Providing leadership and management within Neuroscience Therapeutic Area Clinical Development to provide scientific and clinical development support for products (assets) within assigned therapy area. Support development and execution of medical & clinical strategy for assigned Ipsen assets(s). Conduct scientific...

  • Clinical Scientist

    Il y a 2 mois

    Les Ulis, France Ipsen Bioscience, Inc. Temps plein

    **Responsibilities**: - Review, analyze, and interpret emerging clinical trial data (including biomarkers, clinical pharmacology, and safety data) and lead preparation for key study meetings (e.g. investigator meetings, monitoring committees, advisory boards) - Partner with the study lead on oversight of clinical trial activities, including safety reviews...

  • Director, Clinical Development Programs

    il y a 1 mois

    Les Ulis, France Ipsen Biopharm Ltd Temps plein

    **Position** Job Title**:Director Clinical Development Programs (CPD)** Division / Function: CDO Manager (Job Title): VP, Clinical Development Operations Neurosciences Location: UK (London) or France (Paris) or USA (Cambridge) **Summary / purpose of the position** - The Clinical Program Director holds full accountability for the global aesthetics...

  • Clinical Biomarker Principal Scientist F/m

    Il y a 3 mois

    Les Ulis, France Ipsen Innovation (SAS) Temps plein

    The clinical Biomarkers principal scientist will be responsible for defining the biomarker strategy, from biomarker identification, through clinical implementation, and up to companion diagnostics development, for multiple programs covering all three therapeutic areas, where needed. He/She will also be responsible for monitoring biomarkers in clinical...

  • Scientist Clinical Biomarkers

    Il y a 5 mois

    Les Ulis, France IPSEN Temps plein

    **Title**: Scientist Clinical Biomarkers H/F **Company**: Ipsen Innovation (SAS) The clinical Biomarkers scientist will be responsible for successfully driving biomarkers activities, for multiple programs covering all three therapeutic areas (Oncology, Neuroscience, Rare Diseases), where needed. He/She will contribute to define biomarker plans for each...

  • Senior Scientist Clinical Biomarkers

    Il y a 3 mois

    Les Ulis, France Ipsen Innovation (SAS) Temps plein

    **Primary responsibilities**: - Contributes to the development of clinical biomarker strategies and establishes biomarker plans for target engagement, pharmacodynamics, mechanism of action, and patient selection that are suitable for informed decision-making - Monitors clinical implementation and validation of biomarkers - Selects the most relevant...

  • Clinical Trial Associate

    Il y a 5 mois

    Les Ulis, France Ipsen Innovation (SAS) Temps plein

    **Purpose of the position** - Assists and provides support to the members of the clinical operations study team in administrative activities in order to facilitate the overall management of Company sponsored studies - Executes tasks as assigned by the CPM related to the conduct of clinical studies, study budget forecasting and tracking - Responsible for...

  • Clinical Trial Associate

    Il y a 5 mois

    Les Ulis, France Ipsen Innovation (SAS) Temps plein

    Please send your CV in English ! **Purpose of the position** - Assists and provides support to the members of the clinical operations study team in administrative activities in order to facilitate the overall management of Company sponsored studies - Executes tasks as assigned by the CPM related to the conduct of clinical studies, study budget forecasting...

  • Non-clinical Drug Safety Senior Project Manager

    Il y a 3 mois

    Les Ulis, France Ipsen Innovation (SAS) Temps plein

    **Missions**: - Optimize nonclinical development plans for products. - Collaborate with project/asset teams to deliver optimized development plans. - Handle non-clinical drug safety aspects in various documents (lB, CIA, IMPD, IND, Briefing documents, Expert reports). - Contribute to non-clinical modules for submissions. - Represent the nonclinical function...

  • Senior Site Manager

    Il y a 6 mois

    Issy-les-Moulineaux, France Johnson & Johnson Temps plein

    Vous voulez contribuer à un projet de grande envergure et avoir un impact sur le monde qui vous entoure ? Intégrer Janssen, la division pharmaceutique du Groupe Johnson & Johnson, leader mondial dans le domaine de la santé (126500 collaborateurs dans le monde, 265 entreprises présentes dans 60 pays), c'est participer au développement de solutions...

  • Senior Manager, Cmc Technical Writing

    Il y a 2 mois

    Les Ulis, France Ipsen Innovation (SAS) Temps plein

    Job Title**:Senior Manager, CMC Technical writing Division / Function: Global Regulatory Affairs (GRA) Manager (Name, Job Title): Director/ Sr Director, CMC Regulatory Location: Balard/ Dublin/ Paddington **Summary / purpose of the position** The Senior manager, CMC-technical writing will have responsibility for the CMC (Chemistry Manufacturing and...

  • Pharmacometrician Director

    Il y a 3 mois

    Les Ulis, France Ipsen Innovation (SAS) Temps plein

    **Define and implement the Pharmacometrics Plan for New Chemical Entities (NCE) and New Biological Entities (NBE) to support registration dossiers** - Develop the PMx strategy and contribute to modeling and simulation activities for non-clinical and clinical development projects. - Identify opportunities for MIDD to enhance project support. - Optimize study...

  • Technical Lead

    il y a 3 semaines

    Les Ulis, Île-de-France EMCA Temps plein

    About the Role:We are seeking a highly skilled Senior Software Developer to join our team as a Technical Lead. The successful candidate will have a strong background in software development and experience in leading teams.Key Responsibilities:Lead the development of complex software systemsCollaborate with cross-functional teams to deliver high-quality...

  • Clinical Team Leader

    Il y a 5 mois

    Issy-les-Moulineaux, France Johnson & Johnson Temps plein

    **Nous recherchons actuellement un.e Clinical Team Leader - Biosense Webster H/F en CDI** **Le poste est à pourvoir dès que possible et est basé soit à Reims, soit à Nancy.** **Les départements concernés sont 51, 10, 54, 57, **des déplacements Region Nord Est et France entière sont à prévoir.** Vous voulez contribuer à un projet de grande...

  • Senior Manager Biostatistics

    Il y a 3 mois

    Les Ulis, France Ipsen Innovation (SAS) Temps plein

    **Summary / purpose of the position** - The Senior Biostatistician for Health Technology Assessments (HTA) is an Ipsen Global Biometry biostatistician supporting the development of HTA, in collaboration with Ipsen Health Economics and Outcomes Research (HEOR) and Global Value and Access teams. - He/She is responsible for the discussion and implementation of...

  • "Technical Lead and Senior Software Engineer"

    il y a 3 semaines

    Les Ulis, Île-de-France AMAPII Temps plein

    We are seeking a skilled Technical Lead and Senior Software Engineer to join our team at {company}. As a key member of our engineering team, you will be responsible for leading the development of our software products and ensuring they meet the highest standards of quality and reliability.Key responsibilities include:Designing and implementing software...

  • Senior Manager, Global Regulatory Affairs

    Il y a 3 mois

    Les Ulis, France Ipsen Innovation (SAS) Temps plein

    Job title**:Senior Manager, Global Regulatory Affairs TA** Department: Research & Development, Global Regulatory Affairs (GRA) Line Manager (name, job title): VP/Sr Dir/Dir, Global Regulatory Affairs, Therapeutic Area Location of the role: France, (Les Ulis or Boulogne-Billancourt) **Summary / purpose of the position** - To be accountable for the...