Mehr sehen Kollabieren

Regulatory and Start Up Specialist

vor 2 Monaten

Wien, Österreich Novasyte Vollzeit

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.
_Must be a German fluent with German experience._

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 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.
- 3 years clinical research experience, including 1 year experience in a leadership capacity. 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 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

Wir haben weitere aktuelle Stellen in diesem Bereich, die Sie unten finden können

  • Regulatory and Start Up Specialist

    Vor 5 Tagen

    Wien, Wien, Österreich Novasyte Vollzeit

    Job OverviewPerform 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. _Must be a German fluent with German experience._Essential...

  • Job Posting Title Regulatory and Start Up

    vor 2 Wochen

    Wien, Österreich Novasyte Vollzeit

    Regulatory and Start Up Specialist IQVIA RSU Work from any location Must speak German and English Join us on our exciting journey! IQVIA Clinical Functional Services Partnerships (FSP) business is unique. Our teams are dedicated to a single sponsor partner, where the common goal is quality delivery for our customers. We set ourselves apart with...

  • Fsp Regulatory

    Vor 5 Tagen

    Wien, Österreich Novasyte Vollzeit

    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...

  • Regulatory & Study Start-up Specialist (M/w/d)

    vor 2 Monaten

    Wien, Österreich IQVIA Vollzeit

    We currently offer an exciting opportunity as **Regulatory & Start-Up Specialist (m/w/d)** to work in both fields of _ethics and submissions_ and _contracting and budget negotiations_ in our Country Site Activation Department. You can work in our Vienna office, alternatively you can work home-based as well. **While projects vary, your typical...

  • Regulatory & Study Start-up Specialist (M/w/d)

    Vor 5 Tagen

    Wien, Wien, Österreich IQVIA Vollzeit

    We currently offer an exciting opportunity as Regulatory & Start-Up Specialist (m/w/d) to work in both fields of _ethics and submissions_ and _contracting and budget negotiations_ in our Country Site Activation Department. You can work in our Vienna office, alternatively you can work home-based as well.While projects vary, your typical responsibilities might...

  • Site Start Up Specialist

    Vor 5 Tagen

    Wien, Wien, Österreich Thermo Fisher Scientific Vollzeit

    Our team of colleagues in clinical research services are at the forefront of getting cures to market. We bring a high caliber of scientific and clinical expertise to the development of drugs that address the world's most challenging health concerns. Our Clinical Research team, who powers our PPD clinical research portfolio, are part of our leading global...

  • Site Start Up Specialist

    vor 2 Wochen

    Wien, Österreich Thermo Fisher Scientific Vollzeit

    Our team of colleagues in clinical research services are at the forefront of getting cures to market. We bring a high caliber of scientific and clinical expertise to the development of drugs that address the world’s most challenging health concerns. Our Clinical Research team, who powers our PPD® clinical research portfolio, are part of our leading global...

  • Study Start Up Manager

    vor 1 Woche

    Wien, Österreich Novartis Vollzeit

    The SSO Study Start-Up Manager is accountable for study planning, SSU activities and activation deliverables of assigned projects in compliance with Novartis processes, GCP/ICH and regulatory requirements in a standalone country, OPC (operating country) or satellite country. Leads all SSU activities of assigned projects in close collaboration with SSO...

  • Regulatory and legislative Specialist

    Vor 5 Tagen

    Wien, Wien, Österreich Erste Group Bank AG Vollzeit

    Regulatory and legislative Specialist (all genders) - part-time Location: Wien Working hours: Full-time Occupational Area: Sonstige Company: Erste Group Bank AG Erste Group was founded in 1819 as the first Austrian savings bank and today it is one of the largest banking groups in Central and Eastern Europe (CEE). As an attractive employer, Erste...

  • Internship: Start-up and Partner Management at

    vor 2 Monaten

    Wien, Österreich Infineon Technologies Vollzeit

    In your new role you will be responsible for: - Management of the **"Infineon iHub" **event center **at TU Vienna - Organization of **hackathons **, **workshops **and **presentations **with internal and external team members - Contact and follow up with **Austrian start-up organizations **and **start-up companies**: - Contact and follow up with **academic...

  • Regulatory Specialist

    vor 3 Wochen

    Wien, Österreich Givaudan Vollzeit

    Join us and celebrate the beauty of human experience. Create for happier, healthier lives, with love for nature. Together, with passion and creativity, we deliver food innovations, craft inspired fragrances and develop beauty and wellbeing solutions. There’s much to learn and many to learn from, with more than 16,000 employees around the world to explore...

  • Regulatory and Legislative Specialist

    Vor 5 Tagen

    Wien, Wien, Österreich Erste Group Bank AG Vollzeit

    Erste Group was founded in 1819 as the first Austrian savings bank and today it is one of the largest banking groups in Central and Eastern Europe (CEE). As an attractive employer, Erste Group offers interesting career opportunities in an international environment.Group Prudential Affairs acts as group-wide competence center and advises all Erste Group...

  • Regulatory Specialist

    Vor 5 Tagen

    Wien, Wien, Österreich Givaudan Vollzeit

    Join us and celebrate the beauty of human experience. Create for happier, healthier lives, with love for nature. Together, with passion and creativity, we deliver food innovations, craft inspired fragrances and develop beauty and wellbeing solutions. There's much to learn and many to learn from, with more than 16,000 employees around the world to explore...

  • Group Regulatory Reporting Specialist

    Vor 5 Tagen

    Wien, Wien, Österreich RBI Vollzeit

    Group Regulatory Reporting Specialist (f/m/x) The Group Risk Data & Regulatory Reporting division serves as a center of competence for regulatory reporting, data privacy, risk data matters, and data governance to enhance the risk business architecture.Are you eager to gain insights from the top? Do you have a passion for regulatory reporting and automation?...

  • Project Manager Study-Start-Up

    Vor 5 Tagen

    Wien, Wien, Österreich AUS Fortrea Austria GmbH Vollzeit

    Fortrea: Leading CRO in Clinical DevelopmentFortrea is a top global Contract Research Organization (CRO) dedicated to scientific excellence and extensive experience in clinical development. Serving pharmaceutical, biotechnology, and medical device clients, Fortrea offers a wide array of solutions across 20+ therapeutic areas. With a vast team of over 19,000...

  • Regulatory and legislative Specialist

    vor 1 Monat

    Wien, Österreich Erste Bank Vollzeit

    Working with us means believing in the future; in the great people who are shaping it together every day and in the wide-ranging career paths it opens up. #believeinyourselfRegulatory and legislative Specialist (all genders) - part-timeLocation:ViennaWorking-Hours:Full-timeOccupation Area:OthersCompany: Erste Group Bank AGErste Group was founded in 1819...

  • Regulatory and legislative Specialist

    vor 1 Monat

    Wien, Österreich Erste Bank Vollzeit

     Working with us means believing in the future; in the great people who are shaping it together every day and in the wide-ranging career paths it opens up. #believeinyourself Regulatory and legislative Specialist (all genders) - part-time Location: Vienna Working-Hours: Full-time Occupation Area: Others Company: Erste Group Bank AG Erste Group...

  • Regulatory and legislative Specialist

    vor 1 Monat

    Wien, Österreich Erste Bank Vollzeit

     Working with us means believing in the future; in the great people who are shaping it together every day and in the wide-ranging career paths it opens up. #believeinyourself Regulatory and legislative Specialist (all genders) - part-time Location: Vienna Working-Hours: Full-time Occupation Area: Others Company: Erste Group Bank AG Erste Group...

  • Regulatory and legislative Specialist

    vor 3 Wochen

    Wien, Österreich Erste Bank Vollzeit € 48.323

     Working with us means believing in the future; in the great people who are shaping it together every day and in the wide-ranging career paths it opens up. #believeinyourself Regulatory and legislative Specialist (all genders) - part-time Location: Vienna Working-Hours: Full-time Occupation Area: Others Company: Erste Group Bank AG Erste Group...

  • Regulatory and legislative Specialist

    vor 3 Wochen

    Wien, Österreich Erste Bank Vollzeit € 48.323

     Working with us means believing in the future; in the great people who are shaping it together every day and in the wide-ranging career paths it opens up. #believeinyourself Regulatory and legislative Specialist (all genders) - part-time Location: Vienna Working-Hours: Full-time Occupation Area: Others Company: Erste Group Bank AG Erste Group...