Clinical Operations Manager

vor 3 Wochen

Wien, Österreich IQVIA Vollzeit

**Job Overview**
Direct 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 Functions**
- Oversee the execution of Site Activation (including pre-award/bid defense activities) and/or Maintenance for assigned projects in accordance with the agreed RSU site activation strategy, adhering to project timelines.
- Develop, implement and maintain the Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy, resolving project related issues where required.
- Ensure collaboration across Regulatory & Site Activation, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan.
- Create and/or review technical and administrative documentation to support business development and enable study initiation and maintenance, as required.
- Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.
- Provide overall guidance and oversight of multi-regional and multi-protocol programs during initial start-up and maintenance phase as an integral member of the study management team.
- Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations.
- Identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the site activation plan.
- Assess and review the regulatory landscape and contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required.
- Execute operational strategy/ expectations for maintenance of clinical study approvals, authorizations and review/ negotiation of contracts and essential documents.
- Work with Quality Management to ensure appropriate quality standards for the duration of site activation (or Maintenance, as applicable).
- Mentor and coach colleagues as required. Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans with project specific information.
- May take a lead role in developing long standing relationships with preferred IQVIA customers.
- Deliver presentations/training to clients, colleagues and professional bodies, as required.
- May be involved in activities related to monthly study budget planning and reviews.

**Qualifications**
**Bachelor's Degree Life sciences or related field Req**
**7 years’ relevant experience in a scientific or clinical environment including demonstrable experience in an international role. Equivalent combination of education, training and experience.**
- Strong negotiation and communication skills with ability to challenge.
- Proven ability to work through others to deliver results to the appropriate quality and timeline metrics on complex projects.
- Thorough understanding of regulated clinical trial environment and in-depth knowledge of drug development process
- Good regulatory and/or technical writing skills
- Good leadership skills, with ability to motivate, coach and mentor.
- Good organizational and planning skills
- Ability to exercise independent judgment taking calculated risks when making decisions.
- Proven ability to establish and maintain effective working relationships with co-workers, managers and sponsors.
- Excellent understanding of study financial management
- Proven ability to work on multiple projects balancing competing priorities.

  • Local Clinical Operations Manager

    vor 1 Woche

    Wien, Österreich Johnson & Johnson Vollzeit

    Über Johnson & Johnson - Janssen Seit über 130 Jahren gehören Diversity, Equity & Inclusion (DEI) zu unserer Unternehmenskultur bei Johnson & Johnson. Sie sind ein Grundprinzip unseres täglichen Handelns. Die Würde und Vielfalt aller Menschen zu respektieren, ist eine Verpflichtung, die wir fest in unserem Credo verankert haben. Wir wissen: Um...

  • Clinical Medical Manager

    vor 4 Wochen

    Wien, Österreich Novo Nordisk Vollzeit

    **The Position** This is a regional role that will oversee 9 countries or affiliates within Europe. (As Clinical Medical Manager you will, facilitate execution of clinical trials related to New Therapy Areas (including Chronic Kidney Disease, Cardiovascular Disease, non-alcoholic steatohepatitis/NASH, inflammation, and Alzheimer’s disease) by providing...

  • Clinical Operations Manager

    vor 4 Wochen

    Wien, Österreich Valneva Vollzeit

    or only-in-class vaccine solutions. We have a strong track record, having advanced multiple vaccines from early R&D to approvals, and currently market three proprietary travel vaccines, including the world’s first and only chikungunya vaccine, as well as certain third-party vaccines. **Responsibilities**: - Responsible for all aspects of one or more...

  • Clinical Scientist

    vor 4 Wochen

    Wien, Österreich Hookipa Pharma Vollzeit

    Date: Sep 4, 2023- Location: Wien, AT New York City, US**About HOOKIPA**: HOOKIPA Pharma Inc. (NASDAQ: HOOK) is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies, based on its proprietary arenavirus platform, which are designed to mobilize and amplify targeted T cells and thereby fight or prevent serious disease....

  • Senior Clinical Study Assistant

    Vor 6 Tagen

    Wien, Österreich Labcorp Vollzeit

    The Senior Clinical Study Assistant (CSA) will independently perform tasks related to planning, and execution of clinical studies, supporting the strategy as defined in the Clinical Development Plan. - Provide support for critical day-to-day clinical study activities, including regulatory inspection readiness, in accordance with established protocols under...

  • Clinical Scientist

    vor 4 Wochen

    Wien, Österreich Hookipa Pharma Vollzeit

    **About HOOKIPA**: HOOKIPA Pharma Inc. (NASDAQ: HOOK) is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies, based on its proprietary arenavirus platform, which are designed to mobilize and amplify targeted T cells and thereby fight or prevent serious disease. HOOKIPA’s replicating and non-replicating technologies are...

  • Clinical Strategy Manager

    vor 4 Wochen

    Wien, Österreich Valneva Vollzeit

    Develop clinical study documents and take over individual clinical study tasks - Medical writing for clinical and regulatory documents - Perform clinical study data analysis and interpretation of clinical trials - Organize advisory boards and study committees (Scientific Advisory Boards, DSMBs, Endpoint Adjudication Committees, etc.) - Conduct and summarize...

  • Medical Director

    vor 4 Wochen

    Wien, Österreich Hookipa Pharma Vollzeit

    Date: Sep 4, 2023- Location: Wien, AT New York City, US**About HOOKIPA**: HOOKIPA Pharma Inc. (NASDAQ: HOOK) is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies, based on its proprietary arenavirus platform, which are designed to mobilize and amplify targeted T cells and thereby fight or prevent serious disease....

  • Legal Operations Manager

    vor 4 Wochen

    Wien, Österreich Alliance Defending Freedom Vollzeit

    **Everyone says they want to change the world. We're looking for people who actually will.** - ADF International is a faith-based legal advocacy organization that protects fundamental freedoms and promotes the inherent dignity of all people. Please visit our _career site_ to view our Statement of Faith and Doctrinal Distinctives._ **Legal Operations...

  • Operations Manager in Burger King Und Coffeeshop

    vor 4 Wochen

    Wien, Österreich Burger King Vollzeit

    **Du suchst eine neue Challenge?** Sehr gut - zur Verstärkung unseres operativen Teams in Wien 1100 (Vienna Twin Tower) suchen wir für den sofortigen Eintritt eine/n **Operations Manager*in BURGER KING® und Coffeeshop Company (m/w/d)**: **Deine Aufgaben**: - Laufende Analyse und Optimierung interner Prozesse - Optimierung der Produkte hinsichtlich...

  • Sso Country Manager

    vor 1 Woche

    Wien, Österreich Novartis Vollzeit

    100,000+ That’s how many patients participate in our clinical trials at any given time. GCO is Novartis’ powerhouse of Global Clinical Operations, redesigned to enable faster trial recruitment and enhanced trial delivery resulting in more timely access for patients to potential novel treatments. Every day, we are the link between science and medicine -...

  • (Senior) Manager, Cell Therapy Operations, Account

    vor 22 Stunden

    Wien, Österreich Bristol-Myers Squibb Vollzeit

    **Working with Us** Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...

  • Clinical Research Associate/manager

    vor 4 Wochen

    Wien, Österreich MED−EL Elektromedizinische Geräte Gesellschaft m.b.H. Vollzeit

    Your Tasks- Implementation of surveillance measures for clinical trials - Development of monitoring plans and assistance in completing documents for clinical trials - Ensuring that clinical trials are conducted in accordance with the trial protocol, standard operating procedures, ISO 14155, the Medical Device Regulation, and all applicable legal...

  • Operations and Projects Manager

    vor 4 Wochen

    Wien, Österreich Western Union Vollzeit

    **Operations and Projects Manager** -** Vienna, Austria** Are you a talented leader in Operations and Project Management who is passionate about digital banking and customer excellence? Do you have experience in operation and project management within the financial services industry and a proven track record of implementing operational excellence for...

  • Clinical Trial Assistant, Sponsor-dedicated

    vor 4 Wochen

    Wien, Österreich Labcorp Vollzeit

    **Als Clinical Trial Assistant in unserer Abteilung Flexible Solutions sind Sie von zentraler Bedeutung für die erfolgreiche Durchführung komplexer klinischer Studien (Phasen II und III) in Österreich. **Diese Position ermöglicht es Ihnen, an der Entwicklung innovativer Medikamente, die einen neuen Standard in der Behandlung tausender Patienten weltweit...

  • People Operations Specialist

    vor 1 Woche

    Wien, Österreich Exscientia Vollzeit

    **About Us**: Exscientia is an AI-driven pharmatech company committed to discovering, designing and developing the best possible drugs in the fastest and most effective manner. Exscientia developed the first-ever functional precision oncology platform to successfully guide treatment selection and improve patient outcomes in a prospective interventional...

  • Sales Operations Manager in

    vor 4 Wochen

    Wien, Österreich Investmentpunk Academy GmbH Vollzeit

    Das Sales Team der Investmentpunk Academy wird erweitert. Wir suchen nach einem oder einer eigenverantwortlichen **Sales Operations Manager*in** Unser Team besteht aus jungen, motivierten Mitarbeitern. Wir arbeiten in einem sehr anspruchsvollen wie positiven Arbeitsumfeld und stellen uns jeden Tag neuen Herausforderungen. Die Investment Punk Academy ist...

  • Regional E-Business Operations Manager

    Vor 4 Tagen

    Wien, Österreich Innomotics Vollzeit

     Regional E-Business Operations Manager Job ID: 3861 Location: Vienna, AT, 1210 Zur Verstärkung unseres Teams bei Innomotics (a Siemens Business) suchen wir einen Regional E-Business Operations Manager (m/w/d) Dein Antrieb zur Veränderung. Motoren und Antriebe sind unser Geschäft. Wir definieren Leistung neu - von Kontrollzeiten pro Tag hin zu...

  • Regional E-Business Operations Manager

    vor 1 Woche

    Wien, Österreich Innomotics Vollzeit

     Regional E-Business Operations Manager Job ID: 3861 Location: Vienna, AT, 1210 Zur Verstärkung unseres Teams bei Innomotics (a Siemens Business) suchen wir einen Regional E-Business Operations Manager (m/w/d) Dein Antrieb zur Veränderung. Motoren und Antriebe sind unser Geschäft. Wir definieren Leistung neu - von Kontrollzeiten pro Tag hin zu...

  • Operations Manager

    vor 4 Wochen

    Wien, Österreich Bundesrechenzentrum GmbH Vollzeit

    Beschreibung des BRZ Wir sind das Kompetenzzentrum für Digitalisierung des Public Sectors in Österreich und damit Teil der kritischen Infrastruktur. Ob Digitales Amt, FinanzOnline, Unternehmensserviceportal oder digitaler Führerschein am Smartphone: Im BRZ entwickelte Anwendungen und Services vereinfachen Millionen Menschen den Alltag, indem sie...