Clinical Trial Assistant - Global Impact, Office-Based

Tecnimede Group; Sintra; Presencial; EUR 18 000 - 30 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Competitive salary

Benefits plan

Ongoing training

Resumo da oferta

Tecnimede Group is seeking a detail-oriented Clinical Trial Assistant to join our team in Portugal. You will provide vital administrative and operational support for clinical trials, collaborating with CRAs and Project Managers to ensure timely, compliant, and budget-conscious trial execution.

Ideal candidates have life sciences basics, strong English, and experience in office administration for multiple staff. Proficiency with SAP, MS Office and planning tools is required.

Qualificações

• Educational background in life sciences (preferential).
• Good English level (speaking, writing and listing).
• Previous experience 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.

Responsabilidades

• Setting up and maintaining study files according to regulatory requirements (sponsor master files).
• Archiving study documents and ensuring archive completeness.
• Ensuring study archive is complete, accurate, and ready to be closed out.
• Managing contract signatures and supplier payments per procedures.
• Creation of purchase requests in SAP.
• Periodic budget control and deviation tracking for development projects.
• Assisting the preparation of study documents for regulatory review.
• Delivering relevant study documents to regulatory affairs in a timely manner.
• Managing deficiency letters reception and responses; monthly deficiency letter reporting.
• Setting up events and investigator meetings, study launches, audits and monitoring visits.
• Managing studies insurance and external monitoring schedule.
• Backing up other DMED administrative staff.

Conhecimentos

Life sciences background

English proficiency

Administrative support

MS Office

SAP

Adobe

Data collection & tracking

e-TMF & planning tools

MS Project

ICH-GCP basics

Formação académica

Life sciences degree

Ferramentas

SAP

Adobe

MS Office

MS Project

e-TMF

Descrição da oferta de emprego

Tecnimede Group is seeking a detail-oriented Clinical Trial Assistant to join our team in Portugal. You will provide vital administrative and operational support for clinical trials, collaborating with CRAs and Project Managers to ensure timely, compliant, and budget-conscious trial execution.

Ideal candidates have life sciences basics, strong English, and experience in office administration for multiple staff. Proficiency with SAP, MS Office and planning tools is required.