Descripción: Leads activities associated with the evaluation, initiation and management of clinical studies to ensure compliance with SOPs, EMA and FDA regulations and ICH/GCP guidelines. Leads study ...
Requisitos: Qualifications: BA/BS/MS in a scientific discipline. · Must have demonstrated expertise in relevant clinical operations activities. · Ability to exercise independent judgment within generally defined practices and policies that lead to methods or processes for obtaining results. · Good organization and planning skills. · Strong interpersonal skills and communication skills (both written and oral). · Ability to problem solve. · Knowledge of ICH/GCP guidelines and EMA regulations. · Self-motivated and adaptable to a dynamic environment. · Able to collaborate effectively with the project team and external partners. · Able and willing to travel approximately 25-30%. Experience: · 4+ years of relevant clinical experience in a CRO, pharmaceutical, or biotechnology company (including at least 3 years of CRA experience). · Experience in working with Advanced Therapy Medicinal Products (ATMPs). · Experience in Peripheral Arterial Disease (PAD)/Critical Limb Ischemia (CLI)