Senior Clinical Project Manager

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🔥 0 minutes ago

🐊 Florida, Texas – Remote

🐊 Florida – Remote 🤠 Texas – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🏥 Clinical Operations

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INSIGHTEC

WebsiteLinkedInAll Job Openings

201 - 500 employees

💊 Pharmaceuticals

🔬 Science

💰 $100M Debt Financing on 2022-08

Healthcare • Pharmaceuticals • Science

INSIGHTEC is a company pioneering the use of incisionless focused ultrasound technology to treat neurological disorders such as Essential Tremor and Tremor-Dominant Parkinson’s Disease. Their Exablate Neuro platform allows for precision treatment that is incision-free, guided by MRI and offers real-time safety monitoring, often with immediate results and minimal risks. By targeting specific areas of the brain with acoustic energy, they provide a non-invasive alternative to traditional neurosurgery, promoting life-changing transformations for patients all over the world. INSIGHTEC is committed to advancing healthcare innovation and improving patient care through this transformative technology.

📋 Description

• Responsible for independently leading the clinical trial study team • Managing global clinical trial activities on pivotal trial • Effectively communicates and guides clinical team members • Partners effectively with R&D, Regulatory, Quality, Marketing/Product stake-holders • Management of all clinical studies including developing project management plans • Identification, qualification, and training of investigators and teams • Responsible for the activities related to IRBs/ECs, and clinical study vendors • Proactively manage the data management and data lock processes • Great site relationships with the PI and coordinator

🎯 Requirements

• Bachelor’s degree in a Life Sciences discipline required • Exceptional proficiency in professional English, with advanced medical and scientific writing skills • Demonstrated experience authoring clinical study protocols • Strong presentation and communication skills • Comprehensive knowledge of the medical device clinical trial lifecycle • In-depth understanding of medical device clinical research • Solid understanding of biostatistics and clinical data interpretation • Minimum of 5–6 years of progressive experience in clinical project management • Experience working directly with regulatory authorities • Proven ability to manage and oversee external clinical vendors • Excellent organizational, leadership, and stakeholder-management skills

🏖️ Benefits

• competitive perks and benefits