Regulatory and Start Up Specialist 2

2 tygodni temu

Warszawa, Mazovia, Polska IQVIA Argentina Pełny etat

Job Overview

Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. Fluent in both English and Polish.

Essential Functions

  • Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary.
  • Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.
  • Perform start up and site activation activities according to applicable regulations, SOPs and work instructions.
  • Distribute completed documents to sites and internal project team members.
  • Prepare site regulatory documents, reviewing for completeness and accuracy.
  • • Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
  • Review and provide feedback to management on site performance metrics.
  • Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.
  • Inform team members of completion of regulatory and contractual documents for individual sites.
  • Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
  • Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
  • Perform quality control of documents provided by sites.
  • May have direct contact with sponsors on specific initiatives.

Qualifications

  • Bachelor's Degree in life sciences or a related field and 3 years' clinical research or other relevant experience; or equivalent combination of education, training and experience.
  • In-depth knowledge of clinical systems, procedures, and corporate standards.
  • Good negotiating and communication skills with ability to challenge, if applicable.
  • Effective communication, organizational, and interpersonal skills.
  • Ability to work independently and to effectively prioritize tasks.
  • Ability to manage multiple projects.
  • Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
  • Knowledge of applicable regulatory requirements, including local regulations, , SOPs and company's Corporate Standards.
  • Understanding of regulated clinical trial environment and knowledge of drug development process.
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at


#J-18808-Ljbffr

  • Regulatory and Start Up Specialist 2

    2 tygodni temu

    Warszawa, Mazovia, Polska IQVIA Pełny etat

    Job Overview Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. Fluent in both English and Polish. Essential...

  • Study Start Up and Regulatory Affairs Specialist

    2 tygodni temu

    Warszawa, Mazovia, Polska Ergomed Pełny etat

    Job Description We are looking for someone who can speak German Provides Study Start-Up Specialist activities in support of assigned projects including regulatory submissions, informed consent review, site contract/budget negotiation, essential document collection and review in preparation of site initiation and activation. Provides leadership to...

  • Study Start-Up Lead

    2 tygodni temu

    Warszawa, Mazovia, Polska Rho, Inc. Pełny etat

    OverviewJoin us in redefining what it means to work for a CRO. Working at Rho, you'll be joining a team who take healthcare and clinical research personally, with shared experiences that drive a passion to heal, cure and solve some of humanity's biggest challenges.At Rho, we're committed to you just as you're committed to us. You'll have the opportunity to...

  • Marketing Specialist

    2 tygodni temu

    Warszawa, Mazovia, Polska Start Up Pełny etat

    We are all about supercharging tech-based businesses. But make no mistake – software development is just a part of what we do at Startup House. Our mission is to deliver all-around support for companies at all stages of development.Our team is currently looking for a Marketing Specialist, who will help us develop our marketing initiatives. This is a...

  • Freelance Designer

    2 tygodni temu

    Warszawa, Mazovia, Polska Start Up Pełny etat

    Hi thereWe know well the enhancing effects freedom and flexibility have on the work and lifestyle of a freelance designer. A flexible workload, the opportunities to choose projects, location independence... As all this holds much value for the design professional, we have a solution for addressing these needs.Who are we?We're about supercharging tech-based...

  • Back-end Freelancer

    2 tygodni temu

    Warszawa, Mazovia, Polska Start Up Pełny etat

    We are all about supercharging tech-based businesses. But make no mistake – software development is just a part of what we do at Startup House. Our mission is to deliver all-around support for startups and growing companies at all stages of development.We connect talented freelancers with cutting-edge projects, offering a platform for you to showcase your...

  • Front-end Freelancer

    2 tygodni temu

    Warszawa, Mazovia, Polska Start Up Pełny etat

    We are all about supercharging tech-based businesses. But make no mistake – software development is just a part of what we do at Startup House. Our mission is to deliver all-around support for startups and growing companies at all stages of development.We connect talented freelancers with cutting-edge projects, offering a platform for you to showcase your...

  • QA Engineer

    2 tygodni temu

    Warszawa, Mazovia, Polska Start Up Pełny etat

    We are all about supercharging tech-based businesses. But make no mistake – software development is just a part of what we do at Startup House. Our mission is to deliver all-around support for startups at all stages of development.OurQA Teamis growing and looking for fresh blood – we're currently searching for an experiencedQuality Assurance...

  • QA Freelancer

    2 tygodni temu

    Warszawa, Mazovia, Polska Start Up Pełny etat

    We are all about supercharging tech-based businesses. But make no mistake – software development is just a part of what we do at Startup House. Our mission is to deliver all-around support for startups and growing companies at all stages of development.We connect talented freelancers with cutting-edge projects, offering a platform for you to showcase your...

  • Senior Regulatory Affairs Specialist/Manager

    2 tygodni temu

    Warszawa, Mazovia, Polska HAYS POLAND Sp. z o.o. Pełny etat

    Senior Regulatory Affairs Specialist/Manager Warsaw, Masovian Voivodeship Job Responsibilities: 1. Stay up-to-date with evolving regulatory requirements in Europe, particularly for medical devices. 2. Offer expert regulatory advice for strategic decision-making, ensuring effective execution of regulatory strategies. 3. Manage maintenance activities and...

  • Developer

    2 tygodni temu

    Warszawa, Mazovia, Polska Start Up Pełny etat

    We are all about supercharging tech-based businesses. But make no mistake - software development is just a part of what we do at Startup Development House. Our mission is to deliver all-around support for startups at all stages of development.Our Development Team is expanding and looking for fresh blood - we're currently looking for a Developer, who will...

  • Senior Developer

    2 tygodni temu

    Warszawa, Mazovia, Polska Start Up Pełny etat

    We are all about supercharging tech-based businesses. But make no mistake - software development is just a part of what we do at Startup Development House. Our mission is to deliver all-around support for startups at all stages of development.Our Development Team is expanding and looking for fresh blood - we're currently looking for a Developer, who will...

  • Senior Technical Project Manager

    2 tygodni temu

    Warszawa, Mazovia, Polska Start Up Pełny etat

    We are all about supercharging tech-based businesses. But make no mistake – software development is just a part of what we do at Startup House. Our mission is to deliver all-around support for startups at all stages of development. Our Project Management Team is growing and looking for fresh blood – we're currently searching for an experienced...

  • Study Start Up Associate II

    2 tygodni temu

    Warszawa, Mazovia, Polska ICON Pełny etat

    ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.With our patients at the centre of all that we do, we help to accelerate the development...

  • Regulatory Affairs Specialist

    2 tygodni temu

    Warszawa, Mazovia, Polska Smith & Nephew Pełny etat

    Regulatory Affairs Specialist page is loaded Regulatory Affairs Specialist Apply locations POL - Warsaw time type Full time posted on Posted 6 Days Ago job requisition id R74567 Life Unlimited.At Smith+Nephew we design and manufacture technology that takes the limits off living. The Regulatory Affairs Specialist is responsible for representing and...

  • Start-up Manager

    2 tygodni temu

    Warszawa, Mazovia, Polska in4ge Pełny etat

    Start-up Manager Branża: sprzedaż online (survival/ militaria)Tryb pracy: 100% zdalny z dowolnego miejsca na świecieForma współpracy: B2BOpis RoliDla naszego Klienta poszukujemy ambitnego i doświadczonego Start-up Managera, który będzie odpowiedzialny za rozwój nowego biznesu oraz skuteczną realizację strategii sprzedaży online w branży...

  • Manager, Study Start Up

    2 tygodni temu

    Warszawa, Mazovia, Polska ICON Pełny etat

    At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration,...

  • Regulatory Affairs Specialist

    2 tygodni temu

    Warszawa, Mazovia, Polska HAYS POLAND Sp. z o.o. Pełny etat

    Regulatory Affairs Specialist / Associate Manager Warszawa, mazowieckie Regulatory Affairs Specialist / Associate Manager Warszawa Warszawa, Mazowieckie, Polska Regulatory Affairs Specialist / Associate Manager Warszawa Warszawa, Mazowieckie, Polska For our client, a global FMCG company, we are looking for a Regulatory Affairs Specialist / Associate...

  • Start-up Manager @

    2 tygodni temu

    Warszawa, Mazovia, Polska In4ge Sp. Z O.o. Pełny etat

    Dla naszego Klienta poszukujemy ambitnego i doświadczonego Start-up Managera, który będzie odpowiedzialny za rozwój nowego biznesu oraz skuteczną realizację strategii sprzedaży online w branży survival.U Kandydatów na to stanowisko cenimy szczególnie innowacyjność, kreatywność i zaangażowanie w działanie.Branża: sprzedaż online (survival/...

  • Study Start-Up Site Manager with French language

    2 tygodni temu

    Warszawa, Mazovia, Polska IQVIA LLC Pełny etat

    Study Start-Up Site Manager with French language (prior experience needed) page is loaded Study Start-Up Site Manager with French language (prior experience needed) Apply locations Sofia, Bulgaria Belgrade, Serbia Budapest, Hungary Warsaw, Poland Zagreb, Croatia time type Full time posted on Posted 30+ Days Ago job requisition id R Site Manager Study...