Project Manager Study-start-up

vor 5 Monaten

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 conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
- As Project Manager Study Start-Up at Fortrea, you are central to the successful start of clinical trials for new compounds in Austria. Not only will this position allow you to stay up to date with the latest scientific breakthroughs across a wide variety of therapeutic areas while collaborating directly with one of our most important sponsors - your work has a genuine impact on improving the health and lives of thousands of patients every day.
- If you are an experienced clinical research professional looking for an opportunity to take on more responsibility, use your leadership skills and significantly raise your profile within the pharmaceutical industry, while leveraging your expertise around clinical study start-up processes, this position is a great opportunity
- Location: Austria / Hybrid model (2 days in Vienna client's office)

What you can expect from us:
- rewarding work in a stable, diverse, respected and highly profitable company-
- a thorough onboarding with support from your personal mentor-
- regular, merit-based salary adjustments-
- excellent training and career development opportunities as well as support with advancing your education-
- a genuine work life balance-
- strong support from Line Management-
- the world's most renowned pharmaceutical companies as our satisfied, repeat customers for many years- Your responsibilities:
- Execute and oversee country submissions and approvals-
- Collaborate with Institutional Review Boards (IRBs), Independent Ethics Committees (IECs) and other regulatory authorities-
- Own both country and site budgets, negotiate and close Clinical Trial Research Agreements, oversee payments and ensure accurate data in our financial systems-
- Manage and coordinate local processes such as clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, data management, documentation requirements, insurance process management and data quality-
- Contribute to the development of local materials and best practices-
- Collaborate closely with other internal and sponsor departments to ensure all country deliverables are met and aligned with global timelines**Education**:
- Degree in a relevant field such as life sciences, biology, biochemistry, chemistry, health care (management), nursing, pharmacology, medicine etc.-
- In lieu of the above, a completed vocational education in the health / life sciences industry and/or equivalent professional experience (e.g. as study nurse, research nurse, study coordinator...)- Experience:
- Solid professional experience in clinical trials within a CRO or a pharmaceutical company with a focus on study start-up processes is a plus (EU-CTR submission experience)-
- Experience with submissions to the Austrian regulatory authorities - observing all local regulations and guidelines as well as international standards such as ICH and GCP-
- Leadership skills demonstrated by coaching, mentoring and coordinating (project) teams locally and/or virtually-
- Autonomous work style with excellent time and project management skills-
- Ability to build trustful, sustainable relationships with a wide variety of stakeholders based on your outstanding listening and communication skills-
- Business fluency in German and English - both spoken and written - is a mustFortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

For more information about how we collect and store your personal data, please see our

Privacy Statement

.

  • Fsp Regulatory

    vor 5 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. Essential Functions - Under general supervision, serve...

  • Clinical Study Manager

    vor 2 Monaten

    Wien, Österreich Valneva Vollzeit

    We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. With operations in Austria, Canada, France, Sweden, the United Kingdom, and the U.S., we are committed to making a positive impact on global public health. Together, we are a global Company which...

  • Regulatory and Start Up Specialist

    vor 5 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...

  • Clinical Study Manager

    vor 1 Woche

    Wien, Wien, Österreich Valneva Vollzeit

    We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. Our team is committed to making a positive impact on global public health.ResponsibilitiesManage all phases of clinical research, from feasibility and start-up to closeoutOversee roles and...

  • Study Physician

    vor 6 Monaten

    Wien, Österreich BOEHRINGER Ingelheim RCV GmbH & Co KG Vollzeit

    **THE POSITION**: The Study Physician is a global role in Clinical Development & Operations at Boehringer Ingelheim. Study Physician is responsible for the medical content and medical oversight in the allocated clinical trials as a qualified and clinically experienced physician. Medical input for the trial and being involved in the project/asset team by...

  • Specialist or Senior Specialist

    vor 5 Monaten

    Wien, Österreich Novasyte Vollzeit

    IQVIA currently offers the exciting opportunity as experienced Study Start-Up Specialist / Site Activation Specialist (m/w/d) to work in the Country Site Activation Department in our Vienna office or in home office throughout Austria. In this role you will perform tasks at a country level associated with clinical research site activation activities in...

  • Clinical Project Manager

    vor 5 Monaten

    Wien, Österreich PSI CRO Vollzeit

    **Company Description** PSI is an award-winning full-service CRO, bringing together more than 2,700 dynamic and knowledgeable individuals working to help impact the future of medicine in more than 60 countries around the world. We support pharmaceutical, biotechnology, and medical device companies with the services needed to perform clinical trials of new...

  • Study Physician

    Vor 2 Tagen

    Wien, Österreich BOEHRINGER Ingelheim RCV GmbH & Co KG Vollzeit

    **The position**: The Study Physician is a global role in Clinical Development & Operations at Boehringer Ingelheim. Study Physician is responsible for the medical content and medical oversight in the allocated clinical trials as a qualified and clinically experienced physician. Medical input for the clinical trial and being involved in the project/asset...

  • Study Physician

    vor 5 Monaten

    Wien, Österreich BOEHRINGER Ingelheim RCV GmbH & Co KG Vollzeit

    **The position**: The Study Physician is a global role in Clinical Development & Operations at Boehringer Ingelheim. Study Physician is responsible for the medical content and medical oversight in the allocated clinical trials as a qualified and clinically experienced physician. Medical input for the trial and being involved in the project/asset team by...

  • Regulatory and Start Up Line Manager

    vor 5 Monaten

    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...

  • Clinical Project Manager

    vor 4 Wochen

    Wien, Österreich Octapharma Vollzeit

    Job ID: 58609- Location: Wien, AT- Job Level: Professionals- Job Category: Research and Development- Employment Type: Temporary employment- Career Level: Octapharma specializes in the development of highly pure pharmaceuticals made of human blood plasma. As part of a family-owned enterprise, Octapharma in Vienna is not only the largest production site, but...

  • Project Manager

    vor 3 Wochen

    Wien, Wien, Österreich Jobbox GmbH Vollzeit

    We are seeking a qualified Project Manager to join our team at {company}. In this role, you will be responsible for leading and coordinating projects from start to finish, ensuring timely delivery and high-quality results.Key Responsibilities:• Oversee project planning and execution• Coordinate with cross-functional teams to ensure project goals are...

  • Performance Marketing Manager

    vor 6 Monaten

    Wien, Österreich Olavson Gmbh Vollzeit

    Hi, wir sind Olav, ein schnell wachsendes E-Commerce Start-up und suchen dich! Werde Teil eines hochmotivierten Teams mit viel Freiraum und Verantwortung. Du bist zahlenaffin, bekannt für dein logisches Denken und fuchst dich gerne in neue Systeme rein, hast Freude am Verständnis und der Analyse von komplexen Zusammenhängen, treibst Optimierungen und...

  • Study Physician

    Vor 3 Tagen

    1120 Wien, Österreich Boehringer Ingelheim RCV GmbH & Co KG Vollzeit

    Study Physician (m/f/d)1120 MeidlingJob ID 17770Job Level Experienced professionalsFunctional area Clinical OperationsSchedule Full-timeOur CompanyAt Boehringer Ingelheim we develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company, we focus on long-term...

  • Study Physician

    Vor 2 Tagen

    1120 Wien, Österreich Boehringer Ingelheim RCV GmbH & Co KG Vollzeit

    Study Physician (m/f/d)1120 MeidlingJob ID 17770Job Level Experienced professionalsFunctional area Clinical OperationsSchedule Full-timeOur CompanyAt Boehringer Ingelheim we develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company, we focus on long-term...

  • Clinical Operations Manager

    vor 5 Monaten

    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...

  • Local Trial Manager

    vor 5 Monaten

    Wien, Österreich Amgen Vollzeit

    **HOW MIGHT YOU DEFY IMAGINATION?** You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology...

  • P2X Project Engineering Manager

    vor 1 Monat

    Wien, Wien, Österreich ANDRITZ Vollzeit

    Make a Global Impact in the Fight Against Climate ChangeANDRITZ is seeking a dynamic Process, Mechanical, or Electrical Engineer to support our entry into the P2X market. In this role, you will take care of essential engineering tasks for our green hydrogen and renewable fuel solutions.Key Responsibilities:Coordinate all engineering tasks within P2X...

  • Clinical Project Manager

    vor 2 Wochen

    Wien, Wien, Österreich PSI Vollzeit

    Job DescriptionTake your career to the next level and lead challenging full-service global clinical research projects. As a Clinical Project Manager, you will manage the full scope of responsibilities and get hands-on involvement in every aspect of the study.Remote or hybrid options available.Your Responsibilities:Manage global, multi-center clinical...

  • Clinical Trial Study Physician

    vor 5 Monaten

    Wien, Österreich BI Pharmaceuticals, Inc. Vollzeit

    We at Boehringer Ingelheim Medicine share one vision: to turn patient-focused innovations into life-changing treatments. We focus on driving medical innovation, combining scientific and patient insights to develop and deliver safe and effective solutions. By concentrating on first-in-class innovations, we aim to set new standards for patient care now and for...