Study Start Up Specialist

2 settimane fa

Bologna, Emilia-Romagna, Italia Pharmiweb A tempo pieno
Job Summary

We are seeking a highly organized and detail-oriented Study Start Up Specialist to join our team. As a key member of our Clinical Operations department, you will be responsible for contributing to the identification, feasibility, and selection of study sites, as well as preparing and tracking regulatory and site-level critical documents.

Key Responsibilities:
  • Collaborate with the Local Study Team to identify and select study sites, ensuring compliance with ICON SOPs, Sponsor SOPs, and applicable country regulations.
  • Prepare, review, and approve regulatory and site-level critical documents, including study protocols, informed consent forms, and insurance certificates.
  • Develop and implement a local submission strategy for regulatory authorities and ethics committees, ensuring timely and accurate submissions.
  • Serve as the primary point of contact for the global RPM/RPA and Local Study Team for new CTA/SA/Notification/General communication with local RA and ECs.
  • Review and prepare all applicable documentation for submission to local RA and ECs, including local language cover letters, labels, and informed consent forms.
  • Negotiate financial agreements with institutions and maintain data tracking for RA and EC study oversight.
  • Contribute to the improvement of study start-up processes and procedures.
Requirements:
  • University degree in biological science or healthcare-related field, or equivalent.
  • Good knowledge of spoken and written English.
  • Good ability to learn and adapt to work with IT systems.
  • Good knowledge of GCP.
  • Good time management and organization skills, with the ability to prioritize and multitask.
  • Good oral and written communication skills.
  • Goal-oriented attitude.
  • Diplomatic and interpersonal skills.
  • Good attention to detail.
  • Ability to work independently and as part of a team.
  • Previous experience in a similar role, preferably with CTIS.
What We Offer:

We offer a competitive salary, a range of benefits, and opportunities for professional growth and development. Our benefits include various annual leave entitlements, health insurance, retirement planning, and a global employee assistance program. We are an equal opportunity employer and are committed to providing a workplace free of discrimination and harassment.

  • Specialista Acquisizioni per Start Up

    6 giorni fa

    Bologna, Emilia-Romagna, Italia Adecco Italia Spa A tempo pieno

    Descrizione del LavoroAdecco Italia Spa ricerca un/una Procurement Bidding Start Up Specialist per conto di NBI Spa, impresa specializzata in Ingegneria impiantistica industriale e civile, Costruzioni integrate, Manutenzione impianti, Efficientamento energetico.Compiti PrincipaliIdentificazione dei fornitori e degli appaltatori da coinvolgere nelle analisi...

  • Specialista Acquisizioni e Start Up

    6 giorni fa

    Bologna, Emilia-Romagna, Italia Adecco Italia S.P.A. A tempo pieno

    Adecco Italia Spa ricerca per conto di NBI Spa, impresa specializzata in Ingegneria impiantistica industriale e civile, Costruzioni integrate, Manutenzione impianti, Efficientamento energetico, un/unaSpecialista Acquisizioni e Start UpLa risorsa avrà il compito di gestire le seguenti attività:Identificazione, sotto la supervisione del responsabile Bidding...

  • R&D Engineer

    4 giorni fa

    Bologna, Emilia-Romagna, Italia COESIA A tempo pieno

    Main Responsibilities / ActivitiesAt Coesia, we're driving innovation in mechanical R&D. As a Mechanical R&D Specialist, you'll be responsible for designing and developing innovative packaging solutions. Your tasks will include feasibility studies, design of packaging processes, and development of real-time controls for processes and products vision...

  • Make-up Artist Specialist

    11 ore fa

    Bologna, Emilia-Romagna, Italia MAC A tempo pieno

    Job Title: Make-up Artist SpecialistAt MAC, we are seeking a talented Make-up Artist Specialist to join our team in Bologna. As a Make-up Artist Specialist, you will be responsible for providing exceptional customer service and selling our prestige beauty products.Key Responsibilities:Provide inspirational, authentic and personalized customer serviceWork...

  • Specialista nel Commissioning di Impianti

    2 mesi fa

    Bologna, Emilia-Romagna, Italia Adecco Italia A tempo pieno

    Adecco Italia Spa è alla ricerca di un/una Specialista nel Commissioning e Start Up per un'importante azienda operante nel settore dell'ingegneria impiantistica. La figura selezionata sarà inserita all'interno della Direzione Centrale Impianti e avrà la responsabilità di gestire le attività di avviamento e collaudo degli impianti meccanici ed...

  • Insegnante di skincare e make up

    3 giorni fa

    Bologna, Emilia-Romagna, Italia Adecco Italia A tempo pieno

    Occupazione: Beauty ConsultantDescrizione del lavoro:Stai cercando un'opportunità per crescere in un contesto dinamico e in espansione nel settore della skincare e del make up?Siamo alla ricerca di una persona con passione per il mondo della skincare e del make up che abbia esperienza di almeno 1 anno come Sell Out Specialist nel canale farmacia e/o presso...

  • Beauty Specialist

    3 giorni fa

    Bologna, Emilia-Romagna, Italia Adecco Italia S.P.A. A tempo pieno

    Adecco Outsourcing cerca un Beauty Specialist per un ruolo di promozione di prodotti dermocosmetici. Attività previste:• Pianificazione strategica degli appuntamenti presso i punti vendita• Visite presso le farmacie assegnate• Compilazione di report + feedback qualitativiRequisiti:• Passione per il mondo skincare e make-up• Esperienza di almeno 1...

  • Specialista E-Commerce Junior

    3 giorni fa

    Bologna, Emilia-Romagna, Italia Techyon S.R.L. A tempo pieno

    Techyon S.R.L. è leader nella ricerca e selezione di professionisti senior e manager nel segmento Information Technology. I nostri Recruitment Engineer selezionano i migliori profili IT per prestigiose società di consulenza informatica, banche, aziende di servizi, gruppi manifatturieri, start-up di eccellenza e digital DNA company.La nostra azienda cerca...

  • Digital Sales Specialist

    2 mesi fa

    Bologna, Emilia-Romagna, Italia Wolters Kluwer Italia A tempo pieno

    Descrizione del RuoloWolters Kluwer Italia è una società leader nel settore delle soluzioni digitali e dei servizi per i professionisti del mercato legale, fiscale, finanziario e sanitario.Noi siamo alla ricerca di un Digital Sales Specialist che possa aiutarci a supportare i nostri clienti nella gestione del complesso numero di dati e regolamentazioni che...

  • Product Development Specialist

    2 settimane fa

    Bologna, Emilia-Romagna, Italia Rijk Zwaan Italia S.R.L. A tempo pieno

    Product Development Specialist OpportunityRijk Zwaan Italia S.R.L. is seeking a skilled Product Development Specialist to join our dynamic commercial team in the South of Italy. As a key member of our team, you will be responsible for promoting our full range of vegetable varieties in the Italian market, specifically in Campania, Puglia, Molise, Basilicata,...

  • Mechanical R&D Specialist

    3 settimane fa

    Bologna, Emilia-Romagna, Italia COESIA A tempo pieno

    Join Our Team of InnovatorsWe are seeking a highly skilled Mechanical R&D Specialist to join our Coesia Engineering Center team. As a key member of our team, you will be responsible for designing and developing innovative packaging processes for food and non-food products.Main ResponsibilitiesConduct feasibility studies and design packaging processes for...

  • Specialista per la gestione delle forniture e la gestione dei progetti

    2 settimane fa

    Bologna, Emilia-Romagna, Italia Adecco Italia A tempo pieno

    Descrizione del ruoloAdecco Italia Spa ricerca un/una Procurement Bidding & Start Up Specialist per conto di NBI Spa, una società specializzata in ingegneria impiantistica industriale e civile, costruzioni integrate, manutenzione impianti, efficientamento energetico.Compiti e responsabilitàIdentificare i fornitori e gli appaltatori da coinvolgere nelle...

  • Mechanical R&D Specialist

    4 settimane fa

    Bologna, Emilia-Romagna, Italia COESIA A tempo pieno

    Main ResponsibilitiesWe are seeking a highly skilled and innovative professional to join our Coesia Engineering Center team as a Group R&D Specialist – Mechanical. As a key member of our team, you will be responsible for designing and developing innovative packaging processes and automated machinery solutions.Key Responsibilities:Conduct feasibility...

  • Mechanical R&D Specialist

    3 settimane fa

    Bologna, Emilia-Romagna, Italia COESIA A tempo pieno

    Main ResponsibilitiesWe are seeking a highly skilled and innovative professional to join our Coesia Engineering Center team as a Group R&D Specialist – Mechanical. As a key member of our team, you will be responsible for designing and developing innovative packaging processes and automated machinery solutions.Key Responsibilities:Conduct feasibility...

  • Mechanical R&D Specialist

    2 settimane fa

    Bologna, Emilia-Romagna, Italia COESIA A tempo pieno

    Main ResponsibilitiesWe are seeking a highly skilled and innovative professional to join our Coesia Engineering Center team as a Group R&D Specialist – Mechanical. The ideal candidate will have a strong background in mechanical engineering, with expertise in designing and developing automated machinery and packaging processes.The successful candidate will...

  • Mechanical R&D Specialist

    4 settimane fa

    Bologna, Emilia-Romagna, Italia COESIA A tempo pieno

    About the RoleWe are seeking a highly skilled and innovative Mechanical R&D Specialist to join our Coesia Engineering Center team. As a key member of our team, you will be responsible for designing and developing innovative packaging processes and automated machinery solutions.Main ResponsibilitiesConduct feasibility studies and design packaging processes...

  • Principal Electrical Engineering Specialist

    4 giorni fa

    Bologna, Emilia-Romagna, Italia Https:Www.Energyjobline.ComSitemap A tempo pieno

    Job OverviewWe are seeking a skilled Principal Electrical Engineering Specialist to join our team at Vertiv. With a strong focus on empowering the people who power the future, we design, manufacture, and service the products and solutions that keep the world connected.About the RoleThis position is ideal for a recent engineering graduate or final year...

  • Permitting Specialist

    3 settimane fa

    Bologna, Emilia-Romagna, Italia Opdenergy A tempo pieno

    Job Title: Permitting SpecialistOpdenergy is a leading player in the energy sector, prioritizing being an Independent Power Producer (IPP) with over 15 years of experience and international presence, operating in 9 countries and more than 200 employees.We are seeking a Permitting Specialist to join our team, whose key responsibilities will include:Key...

  • Innovative Mechanical R&D Specialist

    1 settimana fa

    Bologna, Emilia-Romagna, Italia COESIA A tempo pieno

    Main Responsibilities / ActivitiesWe are seeking a highly skilled Mechanical R&D Specialist to join our team at the Coesia Engineering Center. As a key member of our research and development team, you will be responsible for designing and developing innovative packaging processes for food and non-food products.Key responsibilities include:Designing and...

  • Contract Negotiator

    3 settimane fa

    Bologna, Emilia-Romagna, Italia Pharmiweb A tempo pieno

    Job Title: Contract AnalystWe are seeking a highly skilled Contract Analyst to join our team at ICON plc, a world-leading healthcare intelligence and clinical research organisation.About the Role:As a Contract Analyst, you will play a crucial role in driving the costings and contracts negotiations for our clinical studies from start-up through execution and...