Head Of Clinical Operations - [Gpe643]

Detalles de la oferta

About UsIdoven is dedicated to transforming the landscape of cardiology through innovative AI-powered solutions.
Our technology is revolutionizing heart disease prevention, enabling timely diagnosis and treatment for patients around the globe.We're growing fast and looking for a talented Head of Clinical Ops to help shape the look and feel of our products.
If you're passionate about creating amazing user experiences and want to make a big impact, this is a great chance to work on something global, backed by top-notch investors and exciting achievements.Your RoleAs the Head of Clinical Operations, you will do:Lead the clinical affairs function, achieving stated goals and ensuring that clinical trials are conducted per protocol, in a timely fashion, and in a manner compliant with SOPs, ICH/GCP/regulatory guidelines, company goals, and established study budgets.Clinical study design and execution: Be responsible for the development and execution of multiple clinical trials and research efforts, including supporting start-up activities, enrollment, site management, data collection, data reviews, site feasibility, etc.Support data generation strategy and clinical evidence generation: Work closely with product, RD, and commercial team to identify the high-priority areas for data acquisition and clinical evidence generation, understand core medical and scientific literature, and ensure the clinical development strategy is in line with the company's commercial positioning.
Provide medical/scientific support and content expertise in the design and development of customer solutions, presentations, publications, and other collaterals.Clinical lead on regulatory submissions: Guide medical and scientific direction in the preparation and submission of regulatory dossiers, as well as serve as the medical/scientific representative at regulatory meetings as appropriate.KOL engagement: Map out KOLs in the relevant areas, engage and consult to guide the development of our clinical development strategy.Scientific Writing and Publication: Support the publication strategy as well as the manuscript writing and publication process.Minimum Requirements:M.D.
or Ph.D. in a medical or biology-related field.5+ years of work experience in driving cardiology-related clinical studies or clinical evidence development for diagnostics or medical devices.Extensive knowledge in clinical study design and protocol writing including IRB writing and biostatistics.Strong project management skills with attention to detail and experience translating detail to execution of clinical strategies.Experience in building and managing relationships with KOLs.Excellent communication skills and ability to work collaboratively with cross-functional teams.Excellent manuscript writing skills.Experience in clinical software and medical devices, preferred.Strong knowledge of regulatory requirements governing clinical studies (HIPAA, GCP, FDA).A plus: Certification or coursework in clinical research/trial management.You have excellent scientific written and oral communication skills, as well as interpersonal, organizational, and project management skills.Benefits:Be part of one of the most disruptive startups in HealthTech and AI and make a difference.Personal and professional growth as part of a fast-growing, international team.No corners cut in having the best tech equipment to do your job.Enjoy a dynamic remote work setup that allows you to connect with our Madrid office, giving you the freedom to work from home 70% of your week or more!Learning and development opportunities and training budget.Flexible Remuneration.Health Insurance.23 holidays, your birthday off, and December 24th and 31st half days to celebrate!Regular team events and Thursday happy hours.And much more!
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Salario Nominal: A convenir

Fuente: Talent_Dynamic-Ppc

Requisitos

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