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  • Cloud & Infrastructure

    €45000 - €50000 per annum
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    Skills Alliance recrute pour le compte de son client une biotech specialisee dans l Equipment des laboratoires un It Administrateur Systemes et reseaux

    Ceci est un contrat de 6 mois avec une possibilite de Cdi par la suite

    En tant qu administrateur vous prenez en charge les activites liees au fonctionnement et a la maintenance du reseau local de la societe de linfrastructure migration Cloud en Azur et participez a la gestion de reseau etendu de l ensemble des entites du groupe

    Vous etes responsable egalement de l installation et la maintenance du materiel informatique des appareils mobiles et des logiciels pour permettre aux utilisateurs d acceder au reseau

    Missions

    Assurer l assistance technique de premier niveau pour les questions liees aux PC materiel logiciels telecommunications et imprimantes

    Gerer Windows active directory

    Installer configurer et maintenir les serveurs et postes de travail du reseau local

    Tester et evaluer le materiel et les logiciels

    Si vous etes titulaire d un bac plus 5 en informatique et que vous disposez deja d une experience dans un environnement Windows Microsoft server switches routers firewalls TCP IP DNS Microsoft Active Directory VMWare VSphere Office 365 One Drive SharePoint Microsoft Azure ideellement 4 ans je serai ravie de recevoir votre candidature
    L utilisation de l anglais est obligatoire pour ce poste ecrit et oral

    Localisation

    Poste Base a Moirans enMontagne avec des deplacements reguliers au sein de la societe mere basee a Villiers le Bel

  • I am actively recruiting on behalf of a dynamic pharmaceutical company who are launching a COVID-19 Study at with intention to start by the end of Feb.

    The role will be EDC focused and will play a vital role in the supporting the clinical team as they run the remote trial. You will not be in direct contact with the patients and the calls are done remotely, they would like individuals to be open to traveling to sites (Located around the city) should COVID-19 permit at a later date but are set up to work remotely.

    800 patient study with a projected 200 patient calls a month across the team, with 3 individuals looking to be on-boarded in this time I would like talk through the role in more depth and introduce the company.

    They are paying a competitive market rate, if interested please do apply and we can book a call to disscuss this futher.

    This role does not offer sponsorship

  • Company Overview:
    The Clinical Operations team is responsible for the execution of all Phase 1-4 clinical trials, across all therapeutic areas, around the world. In partnership with Clinical Research, Medical Affairs and other Development Operations functions, Clinical Operations ensures that all clinical trial activities are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely delivery of high quality clinical data to support global registration and commercialization of products. For the team based in our International Headquarters in West London, we are looking for a Clinical Trial Manager Associate to work within the Oncology therapy area.

    Essential Duties and Job Functions:
    • Provides administrative assistance in site selection, study implementation and ongoing coordination of study sites, either directly or via CROs.
    • Assist global trial managers with set-up of central labs and study vendors as required, including liaising with study management CRO to ensure site training and timely initiation.
    • Performs accompanied visits (PSSVs, SIVs, RMVs) with CRO CRAs to ensure correct study procedures according to SOPs and protocol procedures, and review of routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs, and Monitoring Plan, as required.
    • Under supervision may assist in review of protocols, informed consents, and case report forms, monitoring plans, abstracts, presentations, manuscripts and clinical study reports. May assist in compilation of investigator brochures under close supervision.
    • Review of trip reports generated by CRO CRAs
    • Communicates and collaborates with other functional groups including but not limited to Clinical Research, Regulatory Affairs, CCF, Materials and Logistics (M&L), and Drug Safety and Public Health (DSPH) to ensure efficient management of study activities.
    • Assists with the preparation and organization of international investigator meetings. Assists in preparation of safety, interim and final study reports, including resolving data discrepancies.
    • Performs administrative duties in a timely manner as assigned.
    • Travel is required up to 20-30%. (Role is currently remote due to COVID-19)

    Experience, knowledge and skills:
    • Typically requires a BS or BA in a relevant scientific discipline
    • Minimum 2 years relevant clinical trial experience in the pharmaceutical or health care industry or equivalent.
    • CRA experience preferred.
    • Oncology experience preferred but not essential.
    • Excellent verbal, written, interpersonal and presentation skills are required.
    • Must be familiar with routine medical/scientific terminology.
    • Must be familiar with Word, PowerPoint, and Excel.
    • Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable.
    • Must be able to participate in departmental or interdepartmental strategic initiative under general supervision.

    (All applicants must be happy to work through an Umbrella/PAYE as the contract will be inside IR35)

  • Company overview
    Commercial-stage oncology company developing a profoundly different cancer treatment therapy called tumor treating fields (TTFields) for patients with solid tumors. TTFields therapy is a non-invasive, novel, antimitotic treatment modality which utilizes proprietary technology attempting to slow or reverse tumor progression by inducing tumor cell death. Their commercialized product is approved for the treatment of adult patients with glioblastoma (GBM) in the USA, Europe and Israel. In addition this company has ongoing or completed clinical trials and is further expanding its efforts into several other solid tumor indications – non-small cell lung cancer, pancreatic cancer, ovarian cancer and other types of solid cancers.

    As the result of the launch of multiple phase II and III clinical trials we are looking for professionals who would be excited to join a fast-growing, international Clinical Operations team at our Swiss HQ.

    Senior Clinical Trial Manager
    You will be responsible for providing strategic leadership and oversight of clinical trials conducted in Europe (and other regions as needed) to ensure completion on time, within budget and of high quality in compliance with all applicable regulations, guidelines and Standard Operating Procedures. You must have a very good understanding of the project status, be able to proactively identify risks and address them appropriately (including escalation to senior management).

    Responsibilities
    The CTM responsibilities include, but are not limited to the following:
    Drive execution of the assigned clinical trial(s) on a regional level according to agreed timelines, scope and budget which includes:

    • site identification and selection
    • coordination of submissions to Competent Authorities
    • oversight of the enrollment activities on a global, country and site level
    • ensuring timely data collection, cleaning and lock
    • oversight of the clinical monitoring activities
    • oversight of CROs and other vendors

    Focus on quality

    • ensure that clinical trials are conducted in accordance with applicable regulations, ICH GCP, FDA CFR and internal Standard Operating Procedures
    • lead the preparation and follow-up after site, vendor or sponsor audits and inspections
    • be able to work with moderate supervision
    • develop and negotiate site budgets
    • prepare study reports and ensure required tools and tracking databases are kept up to date as required
    • ensure activities comply with the applicable Quality System requirements.
    • other responsibilities as assigned

    Qualifications

    • Bachelor’s degree in Nursing, Medicine or other Life Sciences, or RN degree from an accredited school
    • Minimum of 10 years’ experience working in different positions in the field of clinical trials, including CRA-level experience (both CRO and industry experience are acceptable).
    • Accredited GCP course desirable

    Knowledge/Skills

    • Fluency in English (verbal and written) and excellent communication skills
    • Strong critical thinking and problem solving skills
    • Ability to work well in a team environment
    • Strong critical thinking and problem solving skills
    • Ability to efficiently organize and prioritize work within a multifaceted framework and set deadlines
    • Excellent organizational and record-keeping skills
    • Ability to maintain excellent working relationships with a broad range of trial staff
    • Flexibility in work hours and readiness to travel abroad on a routine basis
    • Advanced computer literacy

    Happy to have remote applicants across the EMEA, with a preferance of being Swiss based, This assignment will but up to 1 FTE looking for applicants ASAP.