- Provide medical/scientific input into the development and execution of clinical trial or clinical research related activities, including initiation and oversight of clinical studies / clinical research within the respective therapeutic area. Support country strategy for Non-Interventional Studies/Investigator Initiated Trial activities.
- Ensure medical enquiries are responded to in a high quality, timely manner, and in accordance with applicable standards; establish standard response documents as appropriate, for frequently asked questions.
- Coordinate review and approval of medical materials and locally developed promotional materials; ensure medical materials provided from global or region for stakeholder engagement and events are tailored to local needs and reviewed/approved per local guidelines.
- Ensure medical insights are provided to cross functional groups, including, but not restricted to: Pharmacovigilance, Regulatory affairs, Market Access, QA, Commercial teams, Brand team and others.
- Responsible for risk identification and assessment, mitigation planning as well as implementation and monitoring of appropriate internal controls within the area of responsibilities.
- Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt
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Clinical Research Medical Advisor - Barcelona, España - Novartis
Descripción
About the role:
Clinical Research Medical Advisor - Haemato-Oncology, Spain, #LI-Remote.
The Clinical Research Medical Advisor is a Global Clinical Development role with medical responsibility for the clinical trial process. It is a bridge between Study Site Operations (SSO) clinical trials and Medical Affairs, aligning technical, operations & strategy.
Based remotely in Spain or alternatively hybrid onsite in Barcelona, we are ideally searching for a Medical Doctor (MD) in Haemato-Oncology with Clinical Development experience but will consider MD's, PhD or Scientist level applications from other therapy areas.
Key Responsibilities: