Regulatory & Start Up Specialist II, MedTech, Poland

7 dni temu

Warszawa, Mazovia, Polska IQVIA Pełny etat 40 000 zł - 80 000 zł rocznie

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.

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

  • B Sc Degree in Life Sciences or related field

  • 3 years' clinical research experience

  • Polish language proficiency is essential for direct communication with the Competent Authority and Ethics Committees. 

  • 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 clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more

  • Regulatory and Start Up Manager, MedTech, Poland

    7 dni temu

    Warszawa, Mazovia, Polska IQVIA Pełny etat 40 000 zł - 80 000 zł rocznie

    Job OverviewDirect and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work, budget and resources.Essential FunctionsOversee the execution of Site Activation (including pre-award/bid defense activities) and/or...

  • Software Engineer Poland

    7 dni temu

    Warszawa, Mazovia, Polska amp Pełny etat 60 000 zł - 120 000 zł rocznie

    Hey, we're amp, and we're leading the fitness evolution.Forget the guesswork, the clutter, and the compromises—amp brings full-body, AI-powered workouts straight to your home. With intelligent resistance, expert-led programs, real-time progress tracking, and a sleek, space-saving design, we make high-performance training part of everyday life.Our...

  • Regulatory Affairs Specialist-POLAND

    1 tydzień temu

    Warszawa, Mazovia, Polska Indero (formerly Innovaderm) Pełny etat 40 000 zł - 80 000 zł rocznie

    Due to ongoing global expansion, Indero is looking to hire a Regulatory Affairs Specialist. In this position, you will be responsible for preparation and submission of part I and/or part II following EU CTR and other applications created within or outside of the company to ensure documentation comply with applicable regulations and guidelines and contractual...

  • Regulatory Affairs Specialist-POLAND

    7 dni temu

    Warszawa, Mazovia, Polska Indero Pełny etat 40 000 zł - 80 000 zł rocznie

    Due to ongoing global expansion, Indero is looking to hire a Regulatory Affairs Specialist. In this position, you will be responsible for preparation and submission of part I and/or part II following EU CTR and other applications created within or outside of the company to ensure documentation comply with applicable regulations and guidelines and contractual...

  • Start-Up, Project Manager

    7 dni temu

    Warszawa, Mazovia, Polska Indero (formerly Innovaderm) Pełny etat 40 000 zł - 80 000 zł rocznie

    The Start-Up Manager is responsible for overseeing and managing the successful and timely activation of clinical trial sites across multiple countries. This role leads all start-up activities, ensures regulatory compliance, and collaborates with cross-functional teams to meet study timelines and client expectations. The ideal candidate will bring strategic...

  • Manager, Study Start Up

    1 tydzień temu

    Warszawa, Mazovia, Polska ICON plc Pełny etat 900 000 zł - 1 500 000 zł rocznie

    Manager, Study Start Up - Poland, Czechia, Ireland, Portugal - homebased - contract management expertise requiredICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical...

  • Study Start Up Senior Manager

    3 dni temu

    Warszawa, Mazovia, Polska Parexel Pełny etat

    External Job DescriptionIf you want to be part of a leading CRO and transform scientific discoveries into new treatments, then Parexel FSP challenges you to live up to your potential by joining us atSite Start Up Senior Manager, home-based and sponsor dedicated, in Poland.In this role you will oversee a portfolio of sponsor´s studies where the sponsor have...

  • Manager, Study Start Up

    1 tydzień temu

    Warszawa, Mazovia, Polska ICON plc Pełny etat 80 000 zł - 140 000 zł rocznie

    Manager, Study Start Up - Poland, Czechia, Ireland, Portugal - homebased - contract management expertise requiredICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical...

  • Compliance Specialist

    16 godzin temu

    Warszawa, Mazovia, Polska Actalent Pełny etat

    Compliance Specialist – MedTechLocation:Warsaw, Poland (Hybrid or On-site)About the Role:We are seeking a detail-oriented and proactive Compliance Specialist to join our growing team in Poland. This role is critical in ensuring our operations meet internal and external compliance standards, particularly in relation to HCC websites and digital platforms...

  • Bids & Tender Specialist (maternity leave cover)

    7 dni temu

    Warszawa, Mazovia, Polska Johnson & Johnson MedTech Pełny etat 22 000 € - 60 000 € rocznie

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to...