With 800 employees worldwide, Tecnimede Group is united by a shared vision: to innovate for a healthier future. As a fully integrated Portuguese pharmaceutical company, we control the entire drug lifecycle—from R&D to manufacturing—with our own facilities in Portugal and Morocco and a dedicated R&D Center in Torres Vedras (Portugal).
Though proudly Portuguese, our reach is global: we operate directly in over 100 countries, delivering solutions that improve and preserve lives. We're built by people with strength, determination, and vision—because transforming healthcare starts with those who dare to think beyond borders.
Clinical Research Associate (CRA) (M/F)
Location: Sintra
Your Mission:
Managing the external drug products acquisition and its circuit and traceability;
Promoting the acquisition of the reference drug products for the clinical studies;
Promoting and managing the acquisition of the trial related materials;
Ensuring timely packaging, labelling, shipment, storage of Investigational Medicinal Products (IMPs);
Ensuring the accountability of all products and trial related materials delivered and collected at the investigational site;
Taking steps to ensure that the IMP(s) are stable over the period of use; analysing the temperature and humidity records of the IMP(s) during the shipment and storage before its administration;
Develop the layouts and content of IMPs labels and patient Kits
Informing, all parties involved with the handling of the IMP (s) (Contract Research Organisations, Investigators, and Pharmacists), on the acceptable storage conditions, usage instructions, etc;
Managing, compiling and preparing the documents required to clinical trials competent authority submission.
Acting as the main line of communication between the sponsor and CROs and/or investigators;
Reviewing the study documents (clinical and analytical protocol, inform consent form (ICF), CRFs, SmPC/investigator Brochure/ clinical and analytical study reports);
Determining whether the CROS/investigator is maintaining the Essential Documents specified by the GCP;
Ensuring the studies close-out in a timely manner;
Conduction of monitoring visits (if applicable);
Preparing/reviewing the monitoring reports;
Ensuring that adverse reactions/events have been appropriately reported;
Tracking and evaluation of protocol deviations/violations and informing the CTPM about it;
Be aware of all the guidelines, regulations, directives or laws applicable to the study conduction (EMA and ANVISA);
Coordination and supervision of pharmaceutical equivalence and comparative dissolution profile studies.
Acting as main contact point between CROs and pharmaceutical development department concerning analytical studies/procedures.
Acting as non-clinical research associate, participating in the planning management and supervision of non-clinical studies.
Requirements
Degree in Pharmaceutical Sciences (mandatory).
Preferences
1 year of previous experience in clinical trials;
Previous experience in community pharmacy = 2 years;
Previous experience in investigational work at academic level.
Training and experience
Previous experience in project management;
Training in clinical trials monitoring and/or GCP courses;
Characteristics required
Good English (oral, listen and written); preferentially = B2;
Proactive and focused person;
Good capacity to work in a group;
Detail oriented;
Responsible, timelines accomplishment;
Good acceptability to new challenges;
Full office-based work availability.
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.