Aqua Clinical Senior Project Manager

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.