Do you dare to shake up the medical world and improve the lives of patients with chronic degenerative diseases?
Allegro is a revolutionary start-up that designs and develops ground-breaking biomedical nanotechnology for the treatment of osteoarthritis. We are hiring you as
CRA / (Pre) Clinical Trials Manager
As the manager of the pre-clinical and later clinical trials, you perform an essential function in the company and the development of our products. The job features several responsibilities, as you..
- Are responsible for the program management of our regulatory pre-clinical trials, which include in vitro tests (stability, cytotoxicity,…), as well as various in-vivo biocompatibility and efficacy tests.
- Soon thereafter, will be in the lead to migrate from the pre-clinical phase to the clinical phase and conduct our first-in-human studies, followed by the pivotal clinical trial.
- Design the studies, both animal and human; in accordance with the EU and US regulatory framework, which you monitor for updates.
- Define the strategic approach and SOPs. Review and validate the outputs of the studies with regards to the strategy and KPIs.
- Train, support and advise investigators and site staff about study-related matters to ensure compliance.
- Collect data on patient recruitment, site performance, and clinical outcomes. Validate data sources and quality. Perform data analysis and interpretation.
- Manage the different sites, partners, KOLs, and HCPs, together with a budget, performance, and timeline responsibility.
- Participate in the registration process for new products with the competent authorities, in particular by conducting the (pre)-submission meetings and drafting the medical chapters of the file.
- Integrate R&D into the clinical development process.
You have a:
- Master’s degree or PhD in biological or (para-) medical sciences or equivalent by experience
- Minimum of 5 years experience in the medical or pharmaceutical industry within the pre-clinical or clinical sector.
- Experience in regulatory pre-clinical development studies, including studies management in the fields of toxicology and biocompatibility.
- Good knowledge of ISO 13485, ISO 10993, GLP, GMP, and MDR.
- Experience selecting and managing CRO relationships
- Strong project management skills.
- Driver’s license B.
You are a:
- Great communicator in written and spoken English. Dutch is a plus.
- Independent problem solver, but also a great team player.
- Very precise and qualitative in your work, but also flexible and innovative.
- Entrepreneurial and determined.
As a company
An impact- and purposeful environment, in a young start-up that can change the lives of many people suffering from osteoarthritis.
A high-performance and eager culture, An easy and uncomplicated team, but very eager and high-performance.
An opportunity to learn and grow together with the company, make a positive impact and build tomorrow’s future.
- A great remuneration package with a substantial salary.
- Premium working tools (MacBook/Lenovo; iPhone, …).
- A Tesla company car.
You are stationed in our Liège office, with the option to work from home and travel to the sites.
Do you want to join the future? Contact us via e-mail:
- Subject: Application CRA