MCRA is hiring a
Director Neurology, Remote - Worldwide
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Summary
MCRA is seeking a Director of Clinical Affairs - Neurology to support the CRO leadership team in business planning and execution of engagements, with a focus on neurostimulation technologies. The role involves designing and overseeing clinical data collection activities for neurology medical device clinical trials.
Requirements
- Bachelor’s degree in life sciences, health-related discipline or 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
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
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