CEVA SANTE ANIMALE

Aqua Clinical Senior Project Manager

CEVA SANTE ANIMALE  •  Kingdom of Norway (Onsite)  •  2 hours ago
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Job Description

Aqua Clinical Senior Project Manager

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 totally interlinked. More than ever, Ceva is committed to a "One Health" approach.

As part of our “Diversity, Equity and Inclusion” policy, Ceva Animal Heath 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 :

We are seeking an experienced Aqua Clinical Project Senior Manager to be based in Norway to lead clinical studies and field trials for aquaculture animal health products, including vaccines and pharmaceuticals for farmed fish.

The successful candidate will be responsible for planning, coordinating and overseeing clinical studies from design through to final report, ensuring studies are scientifically sound, compliant with regulatory and animal welfare requirements, and delivered on time and within budget. The role will also hold responsibility for disease challenge models used in product development and will serve as a key member of product development project teams, providing clinical evidence to support product registration and claims.

Key Responsibilities

Clinical Studies and Field Trials

Plan, coordinate and oversee aquaculture clinical studies and field trials, including efficacy, safety and field validation studies.

Write study protocols and reports, or review and approve those prepared by contract research organisations (CROs).

Ensure study data quality and readiness for statistical analysis.

Monitor study execution, deviations and close-out activities.

Identify and implement solutions to maintain study timelines and objectives.

CRO and External Partner Management

Propose and select CROs, trial farms and investigators.

Support the establishment of agreements in partnership with Legal and Procurement.

Oversee quality, timelines and costs through regular communication and study meetings.

Lead kick-off and close-out meetings with external partners.

Disease Challenge Models

Lead the development and improvement of disease challenge models used in product development.

Collaborate with internal R&D and laboratory teams and external partners.

Assess purchased models and recommend improvements to ensure they are fit for purpose.

Quality and Compliance

Ensure compliance with GCP (VICH GL9), applicable GLP requirements and animal welfare standards.

Act as Study Monitor or Sponsor Representative where required.

Support SOP development, corrective actions and audits.

Development Projects and Regulatory Support

Serve as a core member of development project teams.

Deliver clinical study packages for registration dossiers.

Contribute to project planning and risk assessment.

Interpret study results in collaboration with Biometry.

Present findings to management, customers, scientific forums and regulatory stakeholders in collaboration with Regulatory Affairs.

Support the translation of study outcomes into customer-relevant evidence.

People, Practices and AI

Share best practice and support the development of colleagues.

Maintain awareness of developments in aquaculture science, GCP and regulatory requirements.

Contribute to the integration of AI into clinical study processes, including protocol and report drafting, data review, study monitoring and literature searches, while ensuring human oversight, data integrity and compliance.

Your profile :

Required

At least 6 years of relevant experience in Atlantic salmon aquaculture, including a minimum of 3 years planning and leading clinical studies or field trials from start to finish.

Hands-on experience with salmon health, aquaculture production and trial conduct in the field.

Experience from an international pharmaceutical or animal health company, including work in cross-functional project teams and, ideally, collaboration with Commercial or Technical teams.

Experience as a study monitor and formal GCP/GLP training.

Experience writing study protocols and reports, and presenting results.

Preferred

Experience with disease challenge models or experimental infection studies in fish.

Practical experience with species other than Atlantic salmon, for example tilapia or pangasius

Experience with veterinary registration dossiers.

CEVA SANTE ANIMALE

About CEVA SANTE ANIMALE

Ceva Santé Animale (Ceva) is the 5th largest global animal health company, led by experienced veterinarians, whose mission is to provide innovative health solutions for all animals to ensure the highest level of care and well-being.

Our portfolio includes preventive medicine such as vaccines and animal welfare products, pharmaceutical solutions for farm and companion animals, as well as equipment and services to provide the best experience for our customers.

With more than 7,200 employees located in 47 countries, Ceva strives daily to bring to life its vision as a One Health company: “Together, beyond animal health”. Our 21 R&D centers and 32 production sites worldwide attest to our commitment to research and the development of increasingly innovative solutions. 

2025 turnover: €1.92 billion.

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Industry
Pharmaceutical & Medicine
Company Size
5,001-10,000 employees
Headquarters
Libourne, FR
Year Founded
1999
Website
ceva.com
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