Project Manager Study-Start-Up

vor 4 Wochen

Vienna, Österreich AUS Fortrea Austria GmbH 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, respectedand highly profitable company

a thorough onboarding with support from your personal mentor

regular, merit-basedsalaryadjustments

excellent training and career development opportunities as well as support with advancing your education

a genuine worklifebalance

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 must

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.

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