Clinical Trial Assistant - Maternity Leave (M/F)

Iqvia; Lisboa; Presencial; EUR 21 000 - 28 000; Tempo integral

Resumo da oferta

A Tecnimede Group procura um Técnico/a Assistente de Ensaios Clínicos para apoiar atividades administrativas e operacionais de ensaios clínicos. Trabalhará em estreita colaboração com CRAs e Gerentes de Projeto para assegurar que os ensaios decorrem conforme planeado, dentro do orçamento e em conformidade com normas regulamentares.

O candidato ideal possui formação em ciências da vida, fluência em inglês e experiência anterior em suporte administrativo multi-funcional, com conhecimento em SAP e

Qualificações

• Experiência prévia em suporte administrativo de ensaios clínicos e documentação regulatória.
• Nível de inglês bom (fala, escrita e listening).
• Conhecimento de ferramentas MS Office, SAP e Adobe.

Responsabilidades

• Configurar e manter os ficheiros de estudo de acordo com os requisitos regulatórios.
• Arquivar documentos de estudo com rigor e atualização.
• Garantir que o ficheiro do estudo está completo e pronto para fecho.
• Gerir assinaturas de contratos e pagamentos a fornecedores conforme procedimentos.

Conhecimentos

Administrative experience

MS Office (incl. Access)

Data collection and tracking

English language skills

Formação académica

Educational background in life sciences (preferential)

Ferramentas

SAP

Adobe

Excel / MS Project

Descrição da oferta de emprego

Descrição do cargo

At Tecnimede Group, we are driven by a clear purpose: improving people's lives through medical science and technology.

As a Portuguese multinational pharmaceutical company with a presence in six countries and products reaching more than 100 markets worldwide, we offer the opportunity to contribute to a business with global impact while building your career from Portugal.

We believe that great ideas can come from anywhere. That's why we foster a collaborative environment where initiative is valued, innovation is encouraged, and people are empowered to challenge existing ways of working and help shape the future of our organization.

Joining Tecnimede means becoming part of a company that invests in growth not only through science and technology, but also through its people. Here, you will find opportunities to learn, develop, and build a meaningful career while contributing to a purpose that makes a difference every day.

If you are looking for a role where your work can create real impact, join us in elevating lives worth living.

We are looking for a detail-oriented and motivated Clinical Trial Assistant to join our dynamic team. You will provide vital administrative and operational support for clinical trials, working closely with Clinical Research Associates (CRAs), Project Managers to ensure trials run smoothly, in a timely manner, stay within budget, and fully comply with regulatory standards.

About the Role

• Setting up and maintaining updated and according to the applicable regulatory requirements the study files of clinical and non-clinical development projects (sponsor master files)


• Archiving study documents


• Assurance that the study archive is complete, accurate and ready to be closed-out


• Managing contract signatures and supplier payment according to the company's procedures


• Creation of purchase requests in SAP software


• Periodic control, identification of occurrences and deviations of development projects budget


• Updating relevant project databases


• Assisting the preparation of study documents


• Delivery of relevant study documents to regulatory affairs department in a timely manner


• Management of deficiency letters reception and corresponding answers


• Monthly report of deficiency letters


• Setting up events and trips (investigators' meetings, study launches, auditing and monitoring visits)


• Studies insurance management


• Managing of external monitoring activities schedule


• Assisting development project staff


• Backing up other DMED administrative staff

Technical Skills

• Educational background in life sciences (preferential)


• Good English level (speaking, writing and listing)


• Previous experience working in administrative role for multiple people


• Knowledge of Microsoft Office (including Access), SAP and Adobe


• Experience in collecting, handling and tracking data


• Proficiency in management tools e-TMF, EDC and planning software (Excel; MS Project)


• Basic knowledge of clinical trials and ICH-GCP guidelines

Other information

• Full time job


• Office based job


• Maternity leave substitution

What we offer

• Competitive salary package and benefits plan


• Opportunity to work on innovative, cutting-edge scientific projects


• International and dynamic work environment with ongoing training programs

In compliance with the provisions of the GDPR and other legislation in force regarding the protection of personal data, the contracting company guarantees that the processing of your personal data is lawful, fair, transparent and limited to the purposes for which your data was collected.