Clinical Operations Specialist

Phiture; Trofa; Presencial; EUR 30 000 - 45 000; Tempo integral

Resumo da oferta

Uma empresa em crescimento na área de operações clínicas busca um Especialista em Operações Clínicas para apoiar a implementação e monitoramento de ensaios clínicos. O candidato ideal terá um diploma em Ciências da Vida e experiência em gestão de projetos clínicos, além de habilidades de comunicação e colaboração. Esta posição oferece a oportunidade de fazer parte de uma equipe dinâmica e contribuir para a melhoria da vida das pessoas em todo o mundo.

Qualificações

• Experiência em gestão de projetos clínicos de ponta a ponta.
• Conhecimento de documentos de estudo clínico.
• Disponibilidade para viajar até 20% do tempo.

Responsabilidades

• Apoiar a implementação de ensaios clínicos e negociação de contratos.
• Monitorar o progresso do estudo e garantir a conformidade com as boas práticas clínicas.
• Colaborar em atividades interdepartamentais conforme necessário.

Conhecimentos

Gestão de Projetos Clínicos

Comunicação

Colaboração em Equipe

Atenção aos Detalhes

Formação académica

Diploma em Ciências da Vida

Descrição da oferta de emprego

Join Our Mission to Improve Lives Worldwide

Reporting to the Senior Manager, Clinical Operations, the Clinical Operations Specialist conducts, supports and monitors the clinical trial operations activities from phase I to phase IV sponsored by Bial, according to the Clinical Development Plan.

The Impact You’ll Make

• Support on clinical trials implementation: identification of third party’s vendors (e.g., CROs; bioanalytical/central/genetics labs), review of proposals, preparation of bid defense meetings, negotiation of master and project agreements, regulatory and ethical activities;
• Support country and site feasibility, site selection, site contracts negotiation, site training/monitoring/motivation, patient recruitment and retention initiatives;
• Support and assist in study progress monitoring (quality management, monitoring visit reports review, co-monitoring visits, protocol deviations report, risk management, audits support, among others);
• Support clinical trials oversight: preparation of study plans (e.g., clinical monitoring plan, protocol deviations management plan, data management plan);
• Support evaluation, planning and control of budget and timelines;
• Collaborate on other department and inter-department activities/tasks as needed, such as purchasing, pharmacovigilance and medical affairs;
• Support clinical trials oversight: preparation of study plans (e.g., clinical monitoring plan, protocol deviations management plan, data management plan);
• Comply with good clinical practice, SOPs, Quality, Health and Safety Policies;
• Collaborate on other department and inter-department activities/tasks as needed, such as purchasing, pharmacovigilance and medical affairs.

What You’ll Bring

• Degree in Life Sciences;
• Demonstrated experience in end-to-end clinical project management, including timelines, budget tracking, resource planning, and risk mitigation;
• Knowledge of study documents (Clinical Trial Protocol, Informed Consent Form, Clinical Study Report, among others);
• Direct experience in interfacing with regulatory authorities;
• Availability to travel up to 20% of the time;
• Ability to understand and communicate scientific information;
• Good communication and social skills;
• Willingness to take on new responsibilities and grow in the role;
• Teamwork and collaboration skills;
• Results oriented and attention to detail.