Senior Manager of Clinical Strategy

Job Description Clinical Strategy & Protocol Development o Lead the development of IRB and clinical study protocols in alignment with company objectives. o Collaborate with surgeons and clinical advisors to design impactful studies that address business and clinical needs. o Participate in the overall clinical strategy planning process, including statistical analysis plans and protocol review cycles. o Submit and manage regulatory applications (FDA and other global agencies). Clinical Execution & Oversight o Oversee clinical study activities including site selection, investigator engagement, initiation, monitoring, and study closeout. o Ensure studies are conducted in compliance with approved protocols, regulatory standards, and timelines. o Perform site visits, oversee test article reconciliation and disposition, and maintain accurate documentation. Data Integrity & Reporting o Ensure the accurate transmission and validation of clinical data to data management centers. o Resolve case report discrepancies and ensure completeness and integrity of clinical records. o Author or support the development of clinical study reports, white papers, and regulatory submissions. Scientific Communication & Publication o Develop and contribute to scientific manuscripts, conference presentations, and publications. o Provide clinical evidence to support marketing claims and product positioning. Cross-Functional Collaboration o Work closely with product management, engineering, regulatory, and medical affairs to ensure alignment between product development and clinical evidence. o Identify clinical evidence gaps across the product portfolio and recommend solutions. Leadership & Innovation o Guide cross-functional teams in the generation of robust clinical evidence. Maintain awareness of evolving industry trends, research methodologies, and regulatory changes We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to View email address on click.appcast.io learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: Skills and Requirements Required Qualifications · Minimum 3-5 years of experience in clinical strategy, clinical operations, or related leadership roles in MedTech or life sciences.

• Deep knowledge of clinical trial design, including randomized controlled trials and regulatory standards (FDA, IRB).
• Strong leadership, communication, and interpersonal skills with the ability to influence diverse stakeholders.
• Proficiency in interpreting clinical data, regulatory submissions, and medical writing.
• Hands-on experience with clinical trial management systems, data analytics, and statistical tools.

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