Project Manager Study-start-up

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.

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