Rising Phase I Clinical Trial Project Lead

Tecnimede Group; Sintra; Presencial; EUR 32 000 - 46 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Health insurance

International projects

Ongoing training

Resumo da oferta

Tecnimede Group in Portugal seeks a Junior Clinical Trial Project Manager to lead Phase I clinical trials, ensuring timely delivery and regulatory compliance. You will oversee site selection, study documentation, regulatory submissions, product handling, monitoring, data closure, and close-out while liaising with sponsors, CROs, ethics committees, and multi-national teams.

The role requires strong ICH-GCP knowledge, budget awareness, and fluency in Portuguese and English, with hands-on

Qualificações

• Bachelor's or Master's degree in Life Sciences.
• Minimum of 1–2 years of proven experience in clinical project management or as a CRA.
• Solid command of ICH-GCP guidelines, European and ANVISA regulations.
• Fluency in Portuguese and English (written and spoken) is mandatory.
• Proficiency in management tools e‑TMF, EDC and planning software (Excel; MS Project).

Responsabilidades

• Plan, execute, and deliver Phase I clinical trials.
• Select research centres, review study documents, regulatory submissions, investigational products management and shipment, monitoring, database closure, final reports and study close-out.
• Liaise between sponsor, regulatory authorities, ethics committees, and research teams.
• Serve as strategic liaison between sponsor, vendors (CROs), and research sites.
• Ensure adherence to timelines, budgets, participants, sample size achievement and international quality standards.
• Ensure activities comply with Good Clinical Practice (GCP/ICH), trial protocols, CROs SOPs and applicable legislation.
• Oversee analytical activities before trial conduction and coordinate CROs with internal teams.

Conhecimentos

ICH-GCP

Budget management

Risk management

Digital literacy (eTMF, EDC)

Regulatory knowledge (EMA/ANVISA)

Portuguese fluency

English fluency

Formação académica

Bachelor's or Master's in Life Sciences

Ferramentas

eTMF

EDC

MS Project

Excel

Descrição da oferta de emprego

Tecnimede Group in Portugal seeks a Junior Clinical Trial Project Manager to lead Phase I clinical trials, ensuring timely delivery and regulatory compliance. You will oversee site selection, study documentation, regulatory submissions, product handling, monitoring, data closure, and close-out while liaising with sponsors, CROs, ethics committees, and multi-national teams.

The role requires strong ICH-GCP knowledge, budget awareness, and fluency in Portuguese and English, with hands-on