Empresa:

Tecnimede Group

Descrição da Função

Tecnimede Group is a 40 years Portuguese multinational company that wants to improve and preserve human life and health through the development, production and marketing of pharmaceutical products with a strong focus on quality and technological innovation. The group covers the entire life cycle of the medicinal products for human use with a strong investment in research and development.

We are looking for a Clinical Trial Project Manager who is passionate about transforming clinical research into concrete solutions for patients with chronic diseases.

In addition to managing timelines, your mission is to ensure the operational efficiency and compliance of multicenter and multinational clinical trials with international quality standards.

About the Role:

• Oversee all phases of Phase II-IV clinical trials, from the selection of research centers and regulatory submissions through to database closure and the issuance of final reports;
• As a project manager, you will be the primary point of contact and directly responsible for the planning, execution, and successful delivery of clinical trials (Phases II-IV);
• Serve as the primary liaison between the sponsor, regulatory authorities, ethics committees, and research teams;
• Serve as the strategic liaison between the sponsor, vendors (CROs, CDMOs), and research sites;
• Ensure strict adherence to timelines, budgets, recruitment metrics, and international quality standards;
• Monitor the project budget, manage contracts with external suppliers (CROs, CDMOs, central laboratories), and process payments to investigators.
• Identify and mitigate risks, anticipating budget deviations and ensuring that recruitment targets are met and exceeded;
• Ensure that all activities comply with Good Clinical Practice (GCP/ICH), clinical trial protocols, and applicable national and international legislation.

Technical Skills:

• ICH-GCP (Good Clinical Practice): In-depth, up-to-date knowledge (e.g., ICH E6 R3) is essential to ensure data integrity.
• Financial Management: Ability to forecast costs, negotiate with suppliers (CROs, pharmaceutical companies), and monitor budget variances;
• Risk-First Thinking: ability to anticipate recruitment delays or compliance issues and create proactive mitigation plans.
• Digital Literacy: Proficiency in CTMS (Clinical Trial Management System), EDC (Electronic Data Capture), and planning software such as MS Project.

About the Desired Profile:

• Bachelor's or Master's degree in Life Sciences (e.g., Biology, Biochemistry, Pharmaceutical Sciences).
• Minimum of 3 to 5 years of proven experience in clinical project management or as a clinical research associate (CRA);
• Solid command of ICH-GCP guidelines and European regulations (CTR/GDPR);
• Excellent leadership skills for multidisciplinary teams, strategic vision, and resilience under pressure;
• Fluency in Portuguese and English (written and spoken) is mandatory;
• Proficiency in management tools (Clinical Trial Management System; Trial Master File) and planning software (Excel; MS Project).

What we offer:

• Competitive salary package and benefits plan (health insurance);
• 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.

Observações

Lisboa (Portugal)