Clinical Evaluation Specialist
Full-time
Description
Work Flexibility: Hybrid<p style="text-align:inherit"></p><p style="text-align:inherit"></p><h2>Who we want:</h2><ul><li><h3>Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.</h3></li><li><h3>Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.</h3></li><li><h3>Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.</h3></li><li><h3>Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.</h3></li><li><h3>Delivers results. A driven player who sets high goals for personal achievement and organizational success. He/she measures success against the best internal and external benchmarks</h3></li></ul><h3></h3><h2>What you will do</h2><h3></h3><h3>The Clinical Evaluation Specialist acts as the lead technical expert in driving this highly complex and demanding process. He/she applies scientific, regulatory and project management skills to establish the evaluation strategy and to compile the body of Clinical Evidence, allowing, in collaboration with the Medical Expert, to reach a legally binding scientific conclusion on the safety and performance of devices in patients, throughout the product lifecycle. </h3><h3>The Clinical Evaluation Specialist bears the operational and regulatory responsibility of individual clinical evaluation reports and may defend them in audit situations. </h3><h3>Tasks include -</h3><ul><li><h3>Driving the establishment of a coherent Clinical Evidence strategy throughout the new product development cycle and fostering alignment with adjacent complex processes (Marketing strategy and claims, regulatory strategy, clinical research strategy, testing strategy). </h3></li><li><h3>Designing compliant and sustainable literature search strategies, and performing complex literature queries to retrieve published clinical data, </h3></li><li><h3>Identifying, appraising, and analyzing all relevant (clinical, PMS, marketing, and testing data) from multiple sources and formats and create a comprehensive scientific review, including in depth statistical analyses, risk management cross-check and descriptive analyses, following complex and rigorous methodologies. </h3></li><li><h3>Analyzing the current medical and scientific trends in the clinical State of the Art on a broad variety of specialized indications and techniques. </h3></li><li><h3>Based on a detailed and up-to-date understanding of US, European and Australian regulatory requirements, and expectations, elaborate, and defend, with the Medical Expert, a conclusion on the overall risk-benefit statement. </h3></li><li><h3>Identify unanswered questions and residual risks in the Clinical Evidence, and design Post Market Clinical Follow Up activities in collaboration with Clinical Research to address these questions. </h3></li><li><h3>Defining and developing Clinical Evaluation and analysis methodologies to adapt to a complex and quickly evolving regulatory and scientific framework. </h3></li><li><h3>Supporting Marketing in the creation and review of collateral and promotional material to ensure alignment of messaging and claims to regulatory compliance, scientific accuracy, and clinical evidence. </h3></li><li><h3>With the Medical Experts, helping to define, plan, and initiate clinical studies and in vitro tests together with all stakeholders from Clinical Research, R&D, Biomechanics and Regulatory.</h3></li></ul><h3></h3><h2>What you need:</h2><h2></h2><h2></h2><h3>Education: University degree (PhD, Master’s or equivalent) in a field related to the life sciences or a relevant medical engineering field (biology, physiology, biomaterials, biomedical engineering or similar). </h3><ul><li><h3>Experience: 3 to 5 years of experience in Scientific or Medical Writing, and/or relevant academic or clinical research experience (PhD, Post-doc) </h3></li></ul><ul><li><h3>Experience in clinical or regulatory affairs preferred </h3></li><li><h3>Experience with orthopedic or trauma devices preferred </h3></li><li><h3>Proactive, independent, team player with a strong service mentality.</h3></li><li><h3>You are characterized by analytical and transdisciplinary reasoning, with a good attention to detail. </h3></li></ul><h3>You value an international working environment, working across sites and indications. </h3><p style="text-align:inherit"></p><p style="text-align:inherit"></p>Travel Percentage: 10%<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p></p><p></p><p></p><p></p>