Clinical Research Medical Advisor
3 semanas atrás
Overview
Clinical Research Medical Advisor role at Novartis Brasil . Summary: supervises execution and interpretation of clinical trial investigations, data collection activities, and clinical operations. Establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports. Assists in new and ongoing clinical research and trials, ensuring efficiency and timely processing of confidentiality agreements and clinical agreements. Supervises protocol compliance and study closure. Manages clinical and regulatory files and maintains the clinical inventory for distribution to research sites. Interfaces with study sites, clinical investigators, CROs and other vendors. Selects, develops and evaluates personnel to ensure efficient operation of the function.
About The Role Key Responsibilities- Validate study designs and assess trial feasibility based on clinical practice and competitive analysis.
- Drive rapid, high-quality initiation of research centers through specialized contributions in planning phases.
- Provide clinical expertise for interactions with Ethics Committees (IRB/EC) and informed consent language.
- Develop study plans addressing recruitment challenges and ensuring data quality.
- Provide robust training on indications, compounds and protocols for internal and external stakeholders.
- Lead clinical recruitment strategies using medical insights and patient engagement.
- Support regulatory inspections and audits with scientific and clinical knowledge.
- Ensure safety standards compliance and provide medical opinion on adverse events.
- Advanced scientific degree (MD highly preferred; PhD or PharmD also considered).
- Strong understanding of clinical development processes and ICH/GCP guidelines.
- Minimum 3 years of experience in clinical development or clinical practice.
- Proven ability to lead cross-functional teams and resolve complex clinical issues.
- Excellent written and spoken English and local language communication.
- Ability to deliver high-quality presentations and adapt to different therapeutic areas.
- Subspecialty training or Real-World Evidence (RWE) experience.
- Familiarity with innovative study designs and data sources such as registries or electronic health records.
Health sciences, Clinical Monitoring, Clinical Trial Protocol, Regulatory Compliance, Decision Making, Drug Development, Clinical Trials, Lifesciences, Clinical Research
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?
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Employment details- Seniority level: Mid-Senior level
- Employment type: Full-time
- Job function: Health Care Provider
- Industries: Pharmaceutical Manufacturing
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