Summary As a Clinical Research medical Advisor (CRMA) you will support one of designated therapeutic areas (Cardio-Renal-Metabolic / Immunology / Neuroscience). In this capacity you will be accountable for all country clinical / medical aspects associated with Development and prioritized Research programs / trials by providing clinical strategic and tactical leadership as the Country Clinical Development representative. (This may involve work across several countries).
It is a bridge between Study Site Operations (SSO) clinical trials and Medical Affairs, aligning technical, operations & strategy.
CRMA’s gather, inform, and act on clinical / medical / scientific insights for clinical trial concept sheets / protocols, Informed Consent Forms (ICFs) and other relevant clinical documents to optimize clinical trial implementation. They also drive the identification and involvement of qualified investigators with greatest recruitment potential, identifies clinical recruitment hurdles and drives clinical recruitment activities to overcome these hurdles.
Working in close collaboration with other country functions (e.g., clinical trial operations, Medical Affairs and Patient Engagement) you will actively contribute to successful allocation, fast clinical trial start-up, timely recruitment, early identification of potential delays, and development and implementation of mitigation plans.
This position is part of the team CRMA GDD and reports directly to the CRMA Head Iberia.
LI-Hybrid
About the Role
Major Accountabilities Validates study designs and makes the final decision on the clinical / medical trial and program feasibility of implementing a clinical trial protocol based on medical / clinical practice and analysis of the competitive environment in the country.
Actively contributes to scientific / clinical / medical aspects of the start-up phase to ensure fast clinical trial site start-up.
Provides clinical / medical expertise to clinical trial operations team members and clinical trial sites for Institutional Review Boards (IRB) / Ethics Committee (EC) interactions.
Provides scientific / clinical / medical expertise during interactions with Country / Cluster external Experts (e.g., Regulatory Authorities, Medical Experts, Advisory Boards, Patient Advocacy Groups, etc.).
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