Clinical research associate

CEVA SANTE ANIMALE; Libourne; Sur place; EUR 40 000 - 70 000; Plein temps

Résumé du poste

An established industry player in animal health seeks a Clinical Operations team member to contribute to innovative clinical studies. This role involves drafting study documents, managing investigator sites, and ensuring compliance with pharmaceutical regulations. The successful candidate will work on national and international projects, ensuring data integrity and quality throughout the clinical trial process. This position offers an exciting opportunity to be part of a mission-driven organization committed to animal health and well-being. Join a collaborative team that values diversity and inclusion while making a meaningful impact on the health of animals and our planet.

Qualifications

• Higher scientific education in life sciences, biology, biotechnology.
• 3 to 5 years' experience as a CRA within a CRO and/or a laboratory.

Responsabilités

• Contribute to drafting and managing study documents.
• Monitor clinical trials in compliance with pharmaceutical regulations.
• Guarantee the quality and integrity of the data collected.

Connaissances

Good knowledge of international regulations

Written and spoken English

CRA experience

RBQM approach

CTMS/eTMF, EDC, ePRO

Formation

Master 2 in life sciences

Outils

CTMS

eTMF

EDC

ePRO

Description du poste

The success of a company depends on the passionate people we partner with.

Together, let's share our talents.

As a global leader in animal health, Ceva Animal Health believes our success is linked to our passionate people researching, developing, producing, and supplying innovative health solutions for all animals, which contributes to the future of our diverse planet.

We are committed to ensuring the highest possible level of care and well-being for farm animals (poultry, pigs, ruminants), companion animals (dogs and cats), and wildlife.

Indeed, our “Together, Beyond Animal Health” vision emphasizes that the health and wellbeing of people, animals, and our planet are interconnected. More than ever, Ceva is committed to a "One Health" approach.

As part of our “Diversity, Equity and Inclusion” policy, Ceva Animal Health is committed to the employment of people with disabilities and will make reasonable accommodations throughout the interview process to ensure an inclusive and accessible experience for all applicants. To request an accommodation, please contact a member of the Ceva Talent Acquisition team.

Your Missions

As a member of the Clinical Operations team, in line with the Pharmaceutical Unit Development objectives, you will participate in the preparation and follow-up of clinical studies. You will work on innovative national and/or international projects across various therapeutic areas. The position is based on the Libourne campus, but national and international travel is expected.

In This Capacity, Your Missions Are

- Contribute to the drafting and management of study documents.
- Select investigator sites, set up contracts, and ensure payment of invoices.
- Manage investigator center logistics (products, biological samples, materials, etc.).
- Monitor clinical trials in compliance with pharmaceutical regulations, particularly Good Clinical Practices: conduct monitoring visits (initiation, interim, and closure) to investigator centers, draft regular monitoring reports, and maintain management charts throughout the study.
- Guarantee the quality and integrity of the data collected: monitor and manage requests for corrections.
- Work closely with data managers to provide an accurate and complete database.
- Participate in quality audits conducted during the study.

Your Profile

- Higher scientific education (Master 2) in life sciences, biology, biotechnology, etc.

Technical Skills

- Good knowledge of international regulations, ICH (VICH GL9 is a plus).
- Good command of written and spoken English.
- 3 to 5 years' experience as a CRA within a CRO and/or a laboratory is desirable.
- Knowledge of RBQM approach and experience using CTMS/eTMF, EDC, ePRO is preferred.

Soft Skills

- Organized and rigorous.
- Flexible and diplomatic.
- Good communication and team spirit.