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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 scientific & medical support and guidance to the operational teams (as per projects) and to other internal stakeholders (e.g. pre-clinical 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 team-work skills, ability to multi-task;Excellent organizational and time management skills, able to prioritize workload to meet deadlines;Autonomy, results oriented and proactivity;Availability to travel.This is a temporary position for a 12-month fixed-term contract.
Create Your Path@BIAL "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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