Remote Director, Neurology Clinical Affairs

Summary

Join MCRA as a leader in neurology medical device clinical trials to support the CRO leadership team with business planning and execution of CRO engagements. As Director, Clinical Affairs – Neurology at MCRA, you will play a critical role in supporting the expansion of CRO operations and expertise in neurology.

Requirements

• Bachelor’s degree in life sciences, health-related discipline 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

Responsibilities

• 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