Clinical Research Physician - Porto, Portugal - Bial
Descrição
Join Our Mission to Improve Lives Worldwide
Designs and medically monitors clinical studies, according to the clinical development plan, in order to assure the delivery of state-of-the-art medical and scientific results, as well as safeguarding the safety, rights and welfare of study participants and the scientific integrity of research results.
The Impact You'll Make
- Design and/or review the clinical study protocol outline and support the clinical development plan;
- Participate in the preparation and medical review of clinical documentation related to new or ongoing clinical studies;
- Support the clinical research and operations team and provide the medical oversight of the clinical studies (Phase I to IV);
- Supervise safety within clinical studies, working closely with the Pharmacovigilance team;
- Collaborate in various scientific publications and meetings related to clinical development;
- Analyse study documentation and data in the preparation of clinical study reports;
- Interact with investigators, KOL's, external consultants and other relevant medical entities in relation to clinical studies or other ongoing projects;
- Analyse and respond to clinical studies medical questions internally and externally (e.g. authorities);
- Provide medical support in due diligence activities;
- Provide scientific & medical support and guidance to the operational teams (as per projects) and to other internal stakeholders (e.g. preclinical research, business development, regulatory, etc);
- Comply with good clinical practice and/or SOPs;
- Comply with the Quality, Environment, R&D, Health and Safety Policies, Standards and Procedures;
- Participate in other department activities, as needed.
What You'll Bring
- Degree in Medicine;
- International experience within neurosciences area (preferred);
- Knowledge of ICH/GCP regulations, FDA and EMA guidance documents, drug development process and clinical monitoring procedures;
- Good communication and teamwork skills, ability to multitask;
- Excellent organizational and time management skills, able to prioritize workload to meet deadlines;
- Autonomy, results oriented and proactivity;
- Availability to travel.
- "The innovative projects continue to motivate me, and the people as well because they are incredibly passionate about what they do, very curious, and unafraid to face the unknown."_
Miguel Fonseca (Senior Data Scientist, Portugal)
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