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    "requisitionDescription": "<div>\n    <link href=\"https://static.workforcenow.adp.com/mas/mdf-components/22.3.26/styles/froala_editor.pkgd.min.css\" rel=\"stylesheet\" type=\"text/css\" />\n    <link href=\"https://static.workforcenow.adp.com/mas/mdf-components/22.3.26/styles/froala_style.min.css\" rel=\"stylesheet\" type=\"text/css\" />\n\n    <div class=\"fr-view\">\n      <p id=\"isPasted\"><strong>SUMMARY: &nbsp;</strong>Responsible for strategic leadership relative to design of clinical studies and interpretation of established literature and Truvic clinical data. &nbsp;Interacts with both internal and external customers to facilitate clinical programs. &nbsp;May select, develop, and evaluate personnel to ensure effective support of Truvic clinical programs. &nbsp;This position contributes to and supports the company&rsquo;s research and development efforts to create high value medical devices to address unmet clinical needs. &nbsp;Manage aspects of clinical operations for early feasibility and other studies. &nbsp;This includes operational leadership relative to planning and executing clinical studies and overseeing data collection and monitoring activities.&nbsp;<br>&nbsp;<br>&nbsp;<strong>ESSENTIAL DUTIES AND RESPONSIBILITIES&nbsp;</strong>include the following:&nbsp;</p><p>Provide strategic leadership and design input for clinical studies including interacting with Key Opinion Leaders on clinical study designs and protocols</p><p>Research, review, analyze, and interpret literature and apply to clinical trial designs and develop proposals to regulatory agencies</p><p>Review, analyze, and interpret clinical trial data</p><p>Manage internal and external clinical statistical analyses to meet objectives</p><p>Write clinical aspects of core study and regulatory documents including clinical research plans, protocols, investigator brochures, clinical study reports and regulatory submissions</p><p>Serve as a scientific and clinical resource and adviser within Truvic including providing guidance to Clinical Trials Management, Regulatory, R&amp;D, and Project Management staff</p><p>Part of a team responsible for managing the preparation and/or review of data listings, summary tables, study results, study reports, and clinical IDE sections</p><p>Prepare presentations for scientific conferences, investigator meetings, and expert advisory meetings</p><p>Develop and review scientific publications</p><p>Assist in clinical evaluation of business development opportunities</p><p>Evaluate and manage investigator-initiated research proposals</p><p>Prepare and maintain Clinical Evidence Reports</p><p>&nbsp;</p><p>May be required to contribute to operational aspects of the clinical function including:&nbsp;</p><p>Identify project sites, define budgets and time required to complete a clinical study concept</p><p>Develop/edit/approve protocols, case report forms, and database specifications</p><p>Recruit investigators / study sites and negotiate support levels</p><p>Ensure appropriate regulatory controls (site and patient) are in place for all study activities</p><p>Manage clinical trial agreements and internal and external review process</p><p>Review Regulatory documentation for completeness and accuracy during study initiation and maintain such documentation throughout the study</p><p>Ensure site adherence to the study protocol, relevant SOPs, GCP/ICH guidelines, HIPAA, trial registration, and all other applicable regulatory guidelines</p><p>Assist site personnel with data changes as needed to ensure clarity and accuracy of data</p><p>Develop/edit/approve protocols, case report forms, database specifications, and statistical plans</p><p>Perform risk analysis of protocols with investigator and internal stakeholder input</p><p>&nbsp;</p><p>Other Responsibilities</p><p>Actively promote and support the Quality Management System, Quality Objectives, Quality Policy, and Management Review process</p><p>Stay up to date on training and ensure training of functional subordinates (if applicable) on all applicable procedures and processes according to Good Manufacturing Practices, applicable FDA and Regulatory requirements</p><p>Inform responsible personnel of concerns involving product quality</p><p>Perform job functions in a safe and effective manner</p><p>Other duties as assigned</p><p>&nbsp;</p><p><strong><u>EDUCATION/EXPERIENCE:&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;</u></strong></p><p>Bachelor&rsquo;s degree in related field and 8+ years&rsquo; clinical research management experience, preferably in medical device industry</p><p>Master&rsquo;s degree (MBA, MSN, MS) or Doctorate highly desirable</p><p>Extensive knowledge of FDA requirements, hospital, and health care environments</p><p>Strong knowledge of GCPs</p><p>5+ years&rsquo; experience in direct management of clinical teams required</p><p>Excellent written and verbal communication skills required</p><p>Experience interacting with physicians, clinicians, and patients</p><p>Must be willing to travel 20 - 30% &nbsp;&nbsp;</p><p>Possesses excellent leadership skills and ability to be very flexible, adaptable, and to work under pressure</p><p>Self-motivated and self-directed; conscientious approach to work assignments; enjoys the challenges of multitasking and working at a fast pace while staying flexible to shift tasks frequently</p><p>Excellent interpersonal and negotiating skills; ability to adapt to changing work priorities; and ability to maintain good working relationships while dealing appropriately with sensitive and confidential matters and with a wide variety of personal and telephone contacts</p><p>Demonstrated record of success and leadership</p><p>Demonstrated success in developing complex clinical affairs strategies across multiple product lines across multiple multi-national geographies</p>\n    </div>\n  </div>\n",
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