Director - Neurology Clinical Affairs

July 26

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MCRA

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Clinical Affairs • Quality Assurance • Regulatory Affairs • Reimbursement • Healthcare Compliance

51 - 200

Description

• Collaborate with other senior Clinical Affairs leadership and executive management to develop operating objectives, organizational structure, and staffing requirements. • Ensure clinical trial projects are properly resourced, managed and executed within budget and in accordance with established timelines and quality standards. • Implement techniques to improve productivity and maintain the most up-to-date practices. • Direct the development of department orientation and other training programs as required. • Direct the development and communication of departmental systems, SOPs, policies, and procedures. • Collaborate with Clinical Quality Assurance on process for CRO vendor selection, evaluation, and oversight. • Develop and review project documents for accuracy, completeness, and compliance with company or client SOPs, GCP, and other regulatory requirements. • Lead and direct project team to ensure that project deliverables meet client timelines. • Approve reports and study communications generated by the project team for distribution to sponsors and investigators. • Ensure consistency and compliance with department and company SOPs as well as departmental training manuals. • Develop and maintain positive relationships, both internal and external to projects, including clients, team members, and site personnel (PIs, Study coordinators, etc.) • Submit status updates to the client/sponsor as required and respond to questions and concerns. • Ensure that departmental training needs are identified and implemented. • Collaborate with other MCRA business units on business development initiatives, including proposal development and bid defenses. • Serve as a clinical project manager for client projects, as needed. • Assist with professional development for Clinical Trial Managers, Clinical Research Associates and Clinical Trial Associates. • Represent MCRA at conferences and meetings as needed. • Complete other duties and projects as assigned. • Ensure all work products comply fully with SOPs, regulations, standards, policies, and the mission of MCRA.

Requirements

• Bachelor’s degree in life sciences, health-related discipline or other relevant degrees. • 10+ years of experience in clinical trials with at least four years of supervisory clinical project management experience in a clinical research environment. • 5+ years of neurostimulation (BCI, DBS, etc.) or similar neurology medical device clinical trial experience required • Expert-level knowledge of neuro medical device trials and lessons learned from most recent execution of these trials. • High degree of creativity in developing new approaches to Neuro and Digital Health products. • Expert-level knowledge of clinical project management, GCPs, and clinical monitoring procedures. • Demonstrated ability to manage multiple clinical studies simultaneously. • Understanding of therapeutic area for assigned clinical projects. • Experience using Electronic Data Capture (EDC) and clinical trial management systems for project management and monitoring. • Must be a talented consensus builder and team player with the ability to engage and influence a multi-functional team • Ability to manage clients independently. • Must be able to coach a diverse group of employees, identify critical milestones, and hold teams and individuals accountable for strategic objectives and tactical execution • Must be able to manage multiple projects and deliverables simultaneously and generate meaningful results. • Ability to adapt to a rapidly changing environment and quickly identify new trends and changes specific to the industry. • Advanced Proficiency with MS Office Suite (Outlook, Word, Ppt, Excel) and internet applications. • Excellent organization and prioritization skills with the ability to handle multiple tasks and meet deadlines while working independently. • Excellent oral and written communication skills. • Experience working with C-Level and senior management. • Expertise in department and personnel management. • Ensure work meets client and company standards. • Assist with hiring and training of qualified candidates. • Oversee the day-to-day workflow of assigned clinical staff.