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Clinical Research Physician
2 semanas atrás
**MISSION**
Design and medical monitoring of clinical studies, focused in neuroscience area, 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.
**MAIN ATTRIBUTIONS AND RESPONSIBILITIES**
- Protocol development from concept to final protocol based on the clinical development plan
- Protocol execution including interaction with investigators, and contributing to data review, data analysis and clinical study report authoring
- Medical expert for clinical study team and medical monitor for Phase I to IV
- Strategic guidance to phase I/III development programs and oversight of global clinical trial team on assigned program
- Supervise safety within clinical studies, working closely with the Pharmacovigilance team
- Interact with investigators, KOL’s, external consultants and other relevant medical entities in relation to clinical studies
- Participate and presentation at academic congresses, investigator meetings and advisory meetings
- Provide scientific & medical support in due dilligence activities
- Provide scientific & medical support and guidance to the operational teams (as per projects) and to other internal stakeholders like non-clinical research, business development and regulatory
- Participate in other department/corporate initiatives and actions that ensure the continued success of the company
- Comply with good clinical practice and/or SOPs;
- Guide the activity to comply with the Quality, Environment, Health and Safety Policies and Standards and Procedures
**REQUIREMENTS**
- Degree in Medicine (MD)
- Scientific clinical research experience in industry or academic setting, preferentially in neuroscience area
- At least 3 years of previous experience as medical monitor in industrial setting
- Publication in peer reviewed journals
- Knowledge of ICH/GCP regulations, FDA and EMA guidance documents, drug development process and clinical monitoring procedures
- Excellent written / oral communication skills
- Excellent organizational and time management skills, able to prioritize workload to meet deadlines
- Promote a positive work environment
**PREFERRED SKILLS**
- Clinical research experience within neurosciences area
- Focus in Innovation
- Ability to think strategically and willingness to take on new responsibilities
- Teamwork and collaboration
- Autonomy, Results oriented and Proactivity
