Regulatory and Start Up Line Manager

vor 1 Woche


Wien, Wien, Österreich Novasyte Vollzeit
Job Overview

Manages a single department or work unit responsible for site activation. Sets goals and objectives for team members for achievement of short-term operational or tactical results. _Must have former people management experience._

Essential Functions

Manages staff's delivery of site activation activities in accordance with organization's policies and applicable regulations.

Responsibilities include planning, assigning, and directing work, assessing performance, and guiding professional development, rewarding and disciplining employee, and addressing employee relations issues and resolving problems.

Ensure that staff has the proper materials, systems access and training to complete job responsibilities. Provide oversight for the execution of the training plan, SOP review and training experiences, as applicable.


Participate, as required, in the allocation of resources to clinical research projects by assigning staff based on their experience and training.

Manage the quality of assigned staff's work through regular review and evaluation of work product.


Identifies quality risks and issues and create appropriate corrective action plans to prevent or correct deficiencies in performance of staff.


Ensures that staff are meeting defined workload and quality metrics through regular review and reporting of findings as outlined by clinical operations management.

Responsible for leading moderate improvements of processes, systems or products to enhance performance of the job area.

Problems faced are difficult and may require understanding of broader set of issues.

Understands and demonstrates management approaches such as work scheduling, prioritizing, coaching and process execution.

Qualifications:

  • Bachelor's Degree Scientific discipline or health care preferred. Pref
  • Typically requires a minimum of 3 7 years of prior relevant experience. Specific requirements may be further defined by function.


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

  • 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...


  • 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...


  • 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...


  • Wien, Wien, Österreich Fortrea Vollzeit

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...


  • Wien, Wien, Österreich Pharmiweb Vollzeit

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...


  • 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...


  • Wien, Wien, Österreich AstraZeneca Vollzeit

    **Study Start-up Manager (M/F/d) - Schwerpunkt Studienverträge****Standort: Wien/Remote**AstraZeneca ist eines der weltweit führenden biopharmazeutischen Unternehmen, welches sich auf die Entdeckung, Entwicklung undVermarktung verschreibungspflichtiger Arzneimittelkonzentriert. Weltweit profitieren Millionen Patient:innen von unseren innovativen...


  • Wien, Wien, Österreich Talentor Sweden AB Vollzeit

    Unser Klient ist ein eigentümergeführtes, pharmazeutisches Unternehmen, das weltweit verschreibungspflichtige Originalpräparate für Fachärzt*innen anbietet, weiterentwickelt und über strategische Zukäufe stetig wächst. Über seine Zentrale in Wien wird sein etabliertes Netzwerk zur Herstellung und zum Vertrieb seiner Produkte gesteuert. Das...


  • Wien, Wien, Österreich Norgine Vollzeit

    MAIN PURPOSE:The Regulatory Affairs Manager is responsible for the lifecycle management of key Norgine Product post EU approval, ensuring smooth integration of new products following launch and all associated on-going regulatory maintenance activities, this includes:Regulatory Impact Assessment of proposed changes and robust strategies for implementation...


  • Wien, Wien, Österreich Takeda Pharmaceutical Vollzeit

    About the role:At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.Join Takeda as...


  • Wien, Wien, Österreich AOP Orphan Pharmaceuticals GmbH Vollzeit

    AOP Health is the European pioneer for integrated therapies for rare diseases and in critical care.To enhance our team in Vienna we are looking for a:_Regulatory Affairs Manager (f/m/d):Professional Skills: University degree in Natural Science At least 2year Regulatory Affairs experience in the pharmaceutical industry in an international environment Indepth...


  • Wien, Wien, Österreich Karriere - Jobportal Vollzeit

    Mit einer Community von rund 900 Forscherinnen, Unternehmerinnen, Start-Uppern und Studierenden inmitten der Südtiroler Alpen begleitet unser Kunde unternehmerische Ideen in die Zukunft.Du willst Entwicklung aktiv mitgestalten und Netzwerke knüpfen? Dann bewirb dich und werde Associate Start-Up Incubator (m/w/d).Aufgaben- Betreuung von bereits inkubierten...


  • Wien, Wien, Österreich Thermo Fisher Scientific Vollzeit

    PPD, now Thermo Fisher's clinical research business, is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services.We are vital links between an idea for a new medicine and the people who need it.We are the people of PPD, part of Thermo Fisher Scientific — thousands of...


  • Wien, Wien, Österreich Viatris Vollzeit

    7083 Mylan Österreich GmbHAt VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.Viatris empowers people worldwide to live healthier at every stage of life.We do so via:Access - Providing high quality trusted medicines regardless of...

  • Start-up Entrepreneur

    vor 1 Woche


    Wien, Wien, Österreich Möbel Ludwig Vollzeit

    Möbel Ludwig ist eine Marke der K. Ludwig Gesellschaft m.b.H., einem österreichischen Familienunternehmen, das im In- und Ausland auf verschiedenen Märkten aktiv ist. Zur Umsetzung eines neuen Vertriebskonzeptes im Online Handel suchen wir einen durchsetzungsstarken und leistungsorientierten**Start-Up Entrepreneur (m/w/d)**:**Ihre Aufgaben**:- Entwicklung...


  • Wien, Wien, Österreich Thermo Fisher Scientific Vollzeit

    PPD, now Thermo Fisher's clinical research business, is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services.At PPD, we are passionate, deliberate, and driven by our purpose- to improve healthAt PPD we hire the best, develop ourselves and each other, and recognize...


  • 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...

  • Start-up Entrepreneur

    vor 1 Woche


    Wien, Wien, Österreich K. Ludwig Ges.m.b.H. Vollzeit

    Möbel Ludwig ist eine Marke der K. Ludwig Gesellschaft m.b.H., einem österreichischen Familienunternehmen, das im In- und Ausland auf verschiedenen Märkten aktiv ist. Zur Umsetzung eines neuen Vertriebskonzeptes im Online Handel suchen wir einen durchsetzungsstarken und leistungsorientiertenStart-Up Entrepreneur (m/w/d)Das erwarten wir von...


  • Wien, Wien, Österreich Viva Wallet Vollzeit

    We are looking for an experienced, high-skilled Regulatory Compliance Manager, passionate about FinTechs, Digital Payments and Innovations, to join our established and fast-growing business within the Southern European Region.RegionThe position will be full time office based within a Viva Wallet office location within the region, comprising: Germany...


  • Wien, Wien, Österreich AstraZeneca Vollzeit

    AstraZeneca ist eines der weltweit führenden biopharmazeutischen Unternehmen, welches sich auf die Entdeckung, Entwicklung und Vermarktung verschreibungspflichtiger Arzneimittel konzentriert. Hauptsächlich haben wir uns auf folgende Therapiebereiche fokussiert: Herzkreislauf, Niere und Stoffwechsel, Onkologie, Atemwege, Entzündungen und...