Clinical Operations Lead

il y a 6 heures


Gent, Belgique QTC recruitment Temps plein

**11 FEB ’22**:The organisation is a clinical-stage Biopharmaceutical organisation focused on the discovery and development of innovative liver biotherapeutics and currently looking for a Clinical Operations Lead. These therapeutics are based on the human microbiome and is based on a ‘Center of Expertise’ for microbiome research and development in the biotech cluster in Ghent, Belgium. At the moment, they are looking for their first Clinical Operations lead to join and reinforce the Clinical Development team, where you translate pre-clinical and translational research into novel and differentiating products and, ultimately, breakthrough microbial strategies for the treatment of conditions associated to impaired intestinal health and immune, metabolic or CNS diseases.

Details
- Biotechnical
- Clinical Research
- Ghent
- 40 hours p/week

Leer ons kennen

**Jouw consultant**:

- Aron Berhane
- +31 23 754 86 60

Over jouw rol

**Zo maak jij het verschil**:
As the Clinical Operations Lead, you will have the opportunity to become a key team member in the organisation’s clinical development team to bring breakthrough live bacterial consortia to the patient in different diseases with high unmet medical needs. The focus will be on the clinical program related to gut-inflammation-associated disorders but you will also be closely involved in the progression to the clinic of other pipeline programs.

The responsibilities won’t stop there as you will be working on the operational aspects during the planning, start-up, conduct and close-out phase of the given trials while ensuring the quality and integrity of the data. This in addition to act as a first point of contact for clinical operations related questions for the several trials you work on. To make sure everything goes as planned, you will contribute to timely development and review of trial-specific documentation, provide updates on trial evolution to the clinical development team and ensure the timely selection and qualification of CRO’s and vendors, their training and management throughout the study to ensure timely and quality deliverables.

Wat nodig is

**Wat jij mee brengt**:

- At least a Bachelor degree in a medical or biomedical discipline
- Excellent knowledge of ICH, European directives and FDA guidelines related to GCP
- Strong experience with clinical development processes where known with immunology, gut, auto-immune diseases or living biological products will be seen as an asset
- Good organisational skills for seamless interactions with Study Teams, Investigators, Clinical staff, Vendors etc. Team player with good communication skills, personal leadership in matrix teas, flexibility and resilience, positive approach, forward thinking, conflict handling and problem solving skills, sense of innovation. Willing and capable to go the extra mile if needed.
- Fluent in Dutch and English, both in written speech

Wat wij bieden

**Jouw voordelen**:
The organisation is also able to offer you the following:

- Annual base salary between €60,000 and €75,000 including holiday allowance and 13th month
- Competitive package with fringe benefits
- Excellent personal and growth package

Terug naar het vacatureoverzicht



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