Junior Clinical Trial Project Manager (M/F)

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

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 organisation.

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 Junior 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 multicentre and multinational clinical trials with international quality standards.

About the Role:

• You will be the primary point of contact and directly responsible for the planning, execution, and successful delivery of clinical trials (Phase I);
• Manage, supervise and participate in all the activities related with mainly Phase I clinical trials, from the selection of research centres, revision of all the study documents, regulatory submissions, investigational products management and shipment to clinical sites, monitoring activities, database closure, issuance of final reports and study close-out;
• Serve as liaison between the sponsor, regulatory authorities, ethics committees, and research teams;
• Serve as the strategic liaison between the sponsor, vendors (CROs), and research sites;
• Ensure strict adherence to timelines, budgets, participants, sample size achievement and international quality standards;
• Ensure that all activities comply with Good Clinical Practice (GCP/ICH), clinical trial protocols, CROs SOPs and applicable national and international legislation;
• Supervise all the analytical activities that are required before the clinical trial conduction and serve as the main contact point between CROs and internal research teams.

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 negotiate with suppliers and monitor budget variances;
• Risk‑First Thinking: ability to anticipate quality or compliance issues and create proactive mitigation plans.
• Digital Literacy: Proficiency in e‑TMFs (electronic trial master file), EDC (Electronic Data Capture), and planning software such as MS Project.
• Regulatory Framework knowledge: EMA and ANVISA

About the Desired Profile:

• Bachelor's or Master's degree in Life Sciences (e.g., Pharmaceutical Sciences, Biomedical sciences, Biology, Biochemistry,).
• Minimum of 1 to 2 years of proven experience in clinical project management or as a clinical research associate (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).

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.