Clinical and Human Factors Specialist

il y a 1 semaine


Le PontdeClaix, Auvergne-Rhône-Alpes, France BD Temps plein

Job Description Summary:

The Clinical & Human Factor Specialist (CHFS) is an integral position within the BDM-PS Clinical & Human Factor Development group within the Medical and Scientific Affairs Department of BD Pharmaceutical Systems.

The CHFS has responsibility for generation of evidence supporting claims of BDM-PS products.

He/she is responsible for developing, supervising, executing, and reporting of studies (clinical trials and Human factors studies in compliance with BD policies and procedures, to contribute to Medical Devices development.


He/she participate in core teams to represent Medical and Scientific Affairs in development phases when a study is in preparation.

The CHFS responsibilities for managing studies for the allocated products under development includes the following:

  • Writing and updating the Clinical Development Plan (CDP)
  • Contributing to task analysis, use FMEA, IFU building and validation
  • Contributing to developing evaluation of BD products (methods and capabilities) to assess endusers acceptance, preference and willingness to adopt the medical device
  • Building study design based on validated CDP
  • Establishing an appropriate budget and timeline for the study with input from the corresponding project core team
  • Working with his/her line manager to ensure support from C&HF expert team members to get support for various element of the study, and with other piers e.g. Statistician to design the study
  • Ensuring appropriate selection, tender management, evaluation of proposals, and once the supplier chosen, training of study supplier; acquire signed supplier documents (contract) within study timelines, up to the approval of final payments
  • Establishing investigational products specifications for HF studies in collaboration with R&D and the Laboratory (externally or internally) and supervising the preparation of the corresponding products on time and in compliance with defined budget
  • Writing/reviewing study documents, as needed such as protocol, CRF, consent form, session guide, database, clinical study report
  • Assure IRB approval if needed and applicable
  • Maintaining study documentation into the central study file
  • Supervising the interface with data management and statistics in developing case report forms, managing data cleanup, and analyzing study data
  • Completing final study report and closing of study file, contributing to publication writing

Primary Work Location:
FRA Le Pont-de-Claix Cedex
  • Worldwide validation engineer

    il y a 4 semaines


    Le Pont-de-Claix, Auvergne-Rhône-Alpes, France BD (Becton, Dickinson and Company) Temps plein

    Job Description SummaryBD Medical - Pharmaceutical Systems is a global leader in supplying the pharmaceutical industry with innovative, high-quality, clinically-proven and customized pre-fillable parenteral drug delivery systems. Our offering includes an extensive portfolio of pre-fillable syringes, self-injection systems, safety and shielding solutions. Our...

  • Business Integrator

    il y a 23 heures


    Le Pont-de-Claix, Auvergne-Rhône-Alpes, France BD (Becton, Dickinson and Company) Temps plein

    Job Description SummaryAs part of the ISC strategic team in Pharmaceutical System, for his material category:• Provides Supply assurance and mid to long term capacity management• Defines Mid to long term sourcing strategy (make vs buy, flows to plant)• Defines Product line extension plansJob DescriptionWe are the makers of possibleBD is one of the...


  • Le Pont-de-Claix, Auvergne-Rhône-Alpes, France Becton Dickinson Temps plein

    Why Join Us?A career at BD means learning and working alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time.To find purpose in the possibilities, we need...

  • Key Account Director

    il y a 1 semaine


    Le Pont-de-Claix, Auvergne-Rhône-Alpes, France BD Philippines Temps plein

    JOB IDR-475614DATE POSTED09/20/2023Job Description Summary: === WE ARE THE MAKERS OF POSSIBLE ===BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of...

  • Facilities Specialist

    il y a 1 semaine


    La Tour-de-Salvagny, Auvergne-Rhône-Alpes, France Maxeon Temps plein

    Powering Positive ChangeIn a world of constant change, the only way to make a meaningful impact is to stay ahead of the curve. That's why at Maxeon Solar Technologies we've been pushing the boundaries of solar innovation every day for 35 years - from the very edge of outer space to countless rooftops below.Our highly advanced solar products are powering the...

  • Technico Commercial H/F

    il y a 4 semaines


    Salon-de-Provence, Provence-Alpes-Côte d'Azur, France THE BEST OF HUMAN Temps plein

    Quelles sont les missions ?Missions :- Construction et développement de la partie commerciale de la société.- Démarchage et acquisition de nouveaux clients dans le domaine du BTP.- Promotion des avantages uniques de nos produits préfabriqués.- Organiser des visites à l'usine pour démontrer la valeur ajoutée des produits.Quel est le profil idéal...

  • Technico Commercial H/F

    Il y a 2 mois


    Salon-de-Provence, Provence-Alpes-Côte d'Azur, France THE BEST OF HUMAN Temps plein

    Quelles sont les missions ?Missions :- Construction et développement de la partie commerciale de la société.- Démarchage et acquisition de nouveaux clients dans le domaine du BTP.- Promotion des avantages uniques de nos produits préfabriqués.- Organiser des visites à l'usine pour démontrer la valeur ajoutée des produits.Quel est le profil idéal...

  • Technico Commercial H/F

    il y a 3 jours


    Salon-de-Provence, Provence-Alpes-Côte d'Azur, France THE BEST OF HUMAN Temps plein

    Quelles sont les missions ?Missions :- Construction et développement de la partie commerciale de la société.- Démarchage et acquisition de nouveaux clients dans le domaine du BTP.- Promotion des avantages uniques de nos produits préfabriqués.- Organiser des visites à l'usine pour démontrer la valeur ajoutée des produits.Quel est le profil idéal...


  • Salon-de-Provence, Provence-Alpes-Côte d'Azur, France Biotech Dental Temps plein

    About UsFrench designer and manufacturer of medical devices and digital solutions for dentists and dental prosthetic laboratories, Biotech Dental is always up for new challenges.Our mission? Empowering dental professionals to provide quality care at a fair price.Our values? Humanity, innovation, and Made in France.Our Group is not just a global player in...

  • Acheteur Technique Mp

    il y a 1 semaine


    Les Roches-de-Condrieu, Auvergne-Rhône-Alpes, France Prayon Temps plein

    Un poste d'Acheteur Technique MP & Emballage est à pourvoir à Saint Clair du Rhône.Missions:- Responsable de l'approvisionnement Emballages et Matières AdditivesAchats techniques et prestations de services:- A partir d'une demande émise par les différences services de l'usine, recherche, consulte et sélectionne les fournisseurs répondant aux...

  • employe commercial

    il y a 2 semaines


    Solliès-Pont, Provence-Alpes-Côte d'Azur, France Intermarché Temps plein

    Intermarché is the original brand of the Les Mousquetaires Group. Its unique positioning as Producers & Retailers is its strength. Building on the agri-food sector of the Les Mousquetaires Group, Intermarché offers healthy, affordable products from French and responsible production. Acting to make eating better accessible to everyone is the commitment that...

  • Prodctn/Maint, Field Svc

    il y a 2 semaines


    Le Cannet, Provence-Alpes-Côte d'Azur, France Otis College of Art and Design Temps plein

    Date Posted: Country: France Location: 756 AVE DU CAMPON, LE CANNET - CAMPON, 06117, France Titre du poste Aperçu duposte Vous souhaitez rejoindre une entreprise à dimension internationale, axée sur le talent, qui valorise la sécurité, l'éthique, la qualité, l'innovation et les possibilités d'évolution pour ses employés ? Otis...


  • Le Revest-les-Eaux, Provence-Alpes-Côte d'Azur, France emeis Temps plein

    Job Title: Summer Replacement Nurse (LE REVEST LES EAUX) M/FCompany: EMEISContract Type: Fixed-termWork Hours: Full-timeWork Schedule: DayJob Description: As summer approaches, our teams in nursing homes, SSR clinics, and Psychiatric clinics deserve a break. To take over from June to September with patients and residents, and experience our daily routine,...

  • Prodctn/maint, Field Svc

    il y a 2 semaines


    Le Cannet, Provence-Alpes-Côte d'Azur, France Otis Temps plein

    Date Posted: Country:France**Location**:756 AVE DU CAMPON, LE CANNET - CAMPON, 06117, France- Titre du poste- Technicien_- (ne)_- de maintenance_Aperçu du posteVous souhaitez rejoindre une entreprise à dimension internationale, axée sur le talent, qui valorise la sécurité, l'éthique, la qualité, l'innovation et les possibilités d'évolution pour ses...


  • Le Pont-de-Claix, France BD Temps plein

    **Job Description Summary**: We are looking for a highly skilled and experienced professional to join our team as a Medical Affairs Team Member. In this role, you will be responsible for representing medical affairs in project teams and ensuring the performance and safety of our products. Your expertise in product safety or clinical and human factors will be...


  • Voisins-le-Bretonneux, France Boston Scientific Corporation Temps plein

    **Filed Clinical Specialist Intern**: - Remote Eligible: Hybrid- Onsite Location(s): Voisins le Bretonneux, FR**Purpose and Passion - Comprehensive Benefits - Life-Work Integration - Community - Career Growth** At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level....


  • Paris, Ile-de-France, France Hologic Temps plein

    Clinical Application Specialist - SurgicalLocation: Paris or LyonPosition Overview: We are seeking a dedicated and experienced Clinical Application Specialist to join our dynamic team. The successful candidate will be responsible for providing clinical expertise, support, and training to customers in our surgical product area. You will play a critical role...


  • Paris, Ile-de-France, France Hologic Temps plein

    Clinical Application Specialist - SurgicalLocation: Paris or LyonPosition Overview: We are seeking a dedicated and experienced Clinical Application Specialist to join our dynamic team. The successful candidate will be responsible for providing clinical expertise, support, and training to customers in our surgical product area. You will play a critical role...


  • Paris, Ile-de-France, France Hologic Temps plein

    Clinical Application Specialist - Surgical (12 month Fixed Term Contract)Location: Paris or Lyon Position Overview: We are seeking a dedicated and experienced Clinical Application Specialist to join our dynamic team. The successful candidate will be responsible for providing clinical expertise, support, and training to customers in our surgical product...


  • Le Pont-de-Claix, France BD Temps plein

    **Job Description Summary**: **Be part of something bigger!** BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 72,000 employees and a presence in virtually every country around the world to address some of the most...


  • Pays de la Loire, France Boston Scientific Temps plein

      Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth   At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of...


  • Pays de la Loire, France Boston Scientific Temps plein

      Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth   At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of...

  • Clinical Specialist

    il y a 4 semaines


    Île-de-France, France Angel Aligner Temps plein

    Seeking a Skilled General Dentist or Orthodontist: Join Us as a Clinical Specialist for the Revolutionary Angel Aligner System!Are you a talented General Dentist or Orthodontist with a proven track record seeking a fulfilling role in a cutting-edge aligner world?We are actively seeking a talented Clinical Specialist to provide crucial educational support to...

  • Clinical Specialist

    il y a 4 semaines


    Île-de-France Angel Aligner Temps plein

    Seeking a Skilled General Dentist or Orthodontist: Join Us as a Clinical Specialist for the Revolutionary Angel Aligner System!Are you a talented General Dentist or Orthodontist with a proven track record seeking a fulfilling role in a cutting-edge aligner world?We are actively seeking a talented Clinical Specialist to provide crucial educational support to...

  • Clinical Operation Lead

    Il y a 2 mois


    Île-de-France Excelya Temps plein

    I-ExcelyaCreated in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care.We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates. Our unique one-stop provider service model - leveraging...

  • Clinical Operation Lead

    Il y a 2 mois


    Île-de-France, France Excelya Temps plein

    I-ExcelyaCreated in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care.We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates. Our unique one-stop provider service model - leveraging...


  • Ile de France Edwards Lifesciences Temps plein

    Throughout our history, Edwards has helped transform the way physicians monitor and take preventative measures for cardio patients. Our Critical Care business unit specializes in advanced hemodynamic monitoring solutions, including artificial intelligence algorithms to provide predictive readings to clinicians, helping them get patients home to their...


  • Salon-de-Provence, France CNES - Centre National d'Etudes Spatiales Temps plein

    Doctorat, 36 mois - Temps plein - Aucune expérience exigée - Maitrise, IEP, IUP, Bac+4 - Humanities & Social Sciences **Mission**: The use of automation technology in transportation, space and industrial processes increases steadily. This is because automation provides efficiency while making the work of operators easier. When new automation is introduced...


  • Le Pont-de-Claix, France BD Temps plein

    **Job Description Summary**: We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products...

  • Clinical Psychologist

    il y a 1 mois


    Sauveterre-de-Guyenne, France Upsilon Global Temps plein

    Upsilon Global are seeking a freelance Clinical Psychologist to support a German Medical Consultancy with an ongoing Neuropsychological programme. We are seeking a Clinical Psychologist based in the Bron/Lyon region, with experience administering Neuropsychological assessments.We estimate 2.5-3.0 hours on site per patient assessment, starting in August 2024....

  • Clinical Psychologist

    il y a 4 semaines


    Sauveterre-de-Guyenne, France Upsilon Global Temps plein

    Upsilon Global are seeking a freelance Clinical Psychologist to support a German Medical Consultancy with an ongoing Neuropsychological programme. We are seeking a Clinical Psychologist based in the Bron/Lyon region, with experience administering Neuropsychological assessments.We estimate 2.5-3.0 hours on site per patient assessment, starting in August 2024....


  • Marly-le-Roi, France Thermo Fisher Scientific Temps plein

    At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...


  • Marly-le-Roi, France Thermo Fisher Scientific Temps plein

    At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...


  • Le Plessis-Robinson, France Siemens Healthineers Temps plein

    Together, we can beat cancer. At Varian, a Siemens Healthineers Company, we bring together the world's best talent to realize our vision of a world without fear of cancer. Together, we work passionately to develop and deliver easy-to-use, efficient oncology solutions. We are part of an incredible community of scientists, clinicians, developers,...