Business Segment: Healthcare Technology & Medical Innovation
Location(s): United States; Wisconsin; Waukesha
About Us: GE is the world's Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry. GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
Role Summary: The Sr. Manager, Clinical Affairs Operations is responsible for providing leadership and proactive direction and management to the GEHC corporate Clinical Affairs operations group, which includes functional roles such as Data Managers, Subject Matter Experts (SMEs), Trainers, Monitors, Programmers and Biostatisticians
Essential Responsibilities: • Manage, mentor, coach and teach direct and indirect reports on activities within areas of responsibility. Manage the recruitment, development & training plans of direct reports. Team members may be co-located with Sr. Manager or may be based in other facilities/countries. • Develop, review and/or approve research procedures to ensure compliant, effective and efficient research process. • Review and approve training materials related to research management process. Conduct training sessions as needed. • Partner with functions, businesses and regions to ensure research process aligns with regulations and meets business needs. • Serve as a subject matter expert for GEHC research management process. • Manage and coordinate external contract research staff and negotiates applicable contracts for clinical trials and projects. • Assist with continuous improvement activities by driving the implementation of process improvement initiatives. • Ensure Research is executed in compliance with Good Clinical Practices and other applicable regulations and company procedures. • Manage outsourcing activities for Clinical Affairs group. • Manage and coordinate key Clinical Affairs operating mechanisms. • Lead development and management of Clinical Affairs quality metrics, including data mining and data analysis. • Support Bioresearch Monitoring (BIMO) and functional audit activities. • Ensure effective collaboration between Clinical Affairs, Medical Affairs, Regulatory Affairs, Legal and Research Managers to meet business objectives.
Qualifications/Requirements: • Experience with clinical research and associated regulatory requirements. • Demonstrated understanding of healthcare environment and knowledge of current competitive, commercial or political situations and their impact on GEHC strategies. • Experience with managing outsourcing of research suppliers (e.g., CROs). • Experience in procedure and training development.. • Excellent verbal and written communication and presentation skills with the ability to communicate business issues in English in an easy to understand manner. • Strong problem solving, influencing and negotiation skills. • Demonstrated experience prioritizing conflicting demands from multiple business entities in an extremely fast paced environment. • Ability to work well independently & in a team setting. • Experience with working across cultures/countries/sites. • Data gathering and analysis skills to generate meaningful metrics and analytics. • Prior experience using spreadsheet and presentation software.
Desired Characteristics: • Bachelor’s degree (or internationally recognized equivalent) in a science, quality or regulatory related field with a minimum of 10 years experience with process management within the medical device or pharmaceutical industry. • Experience interfacing with Regulatory Agencies such as FDA. • 8 or more years of strategic business planning and development, operations and program leadership experience. • Excellent and Proven presentation and negotiation skills • Demonstrated project management skills to prioritize, plan, delegate & evaluate deliverables; well organized and structured, attention to detail. • Proven ability to develop and maintain highly effective teams
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