Operations Manager, Global Clinical Research, China
- GE Healthcare
- Posted 8/16/2017 4:50:23 PM
- Job Function: Engineering/Technology
- Business Segment: Healthcare Technology & Medical Innovation
Location(s): China; BeiJing; Beijing
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.
The Operations Manager, Global Clinical Research, China is responsible for providing leadership, proactive direction and management to the GEHC Clinical Research team in China as a part of the Global Research Organization.
• 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 Director or may be based in other facilities/countries).
• 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
• Ensure research is executed in compliance with Good Clinical Practices and other applicable regulations and company procedures.
• Oversight and management of key Global Research Organization, China operating mechanisms.
• Lead development and management of Global Research Organization quality metrics, including data mining and data analysis for China.
• Support CFDA and Province functional audit activities.
• Ensure effective collaboration between the China Global Clinical Research Organization, Medical Affairs, Regulatory Affairs, and Legal to meet business objectives.
Quality Specific Goals:
1. Deep domain knowledge of and comply with Good Clinical Practice guidelines, the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position.
2. Complete all planned Quality & Compliance training within the defined deadlines.
3. Identify and report any quality or compliance concerns and take immediate corrective action as needed.
1. Bachelor’s degree (or internationally recognized equivalent) in a science, quality or regulatory related field with a minimum of 10 years’ experience with research process management within the medical device or pharmaceutical industry OR minimum of 14 years progressive experience with research process management in medical device or pharmaceutical industry.
2. Experience managing research and related staff.
3. Strong working knowledge of applicable medical device industry regulations and directives (relating to Quality Management System and research).
4. Excellent verbal and written communication and presentation skills with the ability to communicate business issues in English in an easy to understand manner.
5. Demonstrated management skills with a minimum of 5 years management experience.
6. Excellent experience with all aspects of the clinical research process, including site selection, investigator qualifications, monitoring, protocol and report writing.
7. Demonstrated project management skills to prioritize, plan, delegate & evaluate deliverables; well organized and structured, attention to detail.
8. Strong problem solving, influencing and negotiation skills.
9. Proven experience of effective decision making.
10. Demonstrated experience prioritizing conflicting demands from multiple business entities in an extremely fast paced environment.
11. Ability to work well independently and in a team setting.
12. Experience with working across cultures/countries/sites.
13. Data gathering and analysis skills to generate meaningful metrics and analytics.
14. Prior experience using spreadsheet and presentation software.
15. Must be willing to travel.
1. Demonstrated understanding of healthcare environment and knowledge of current competitive, commercial or political situations and their impact on GEHC strategies in China.
2. Experience in procedure and training development.
3. Experience interfacing with Regulatory Agencies such as CFDA and Province Regulatory Agencies.
4. Strong leadership skills; able to inspire others, creating a dynamic environment that fosters transparency, collaboration and innovative thinking.
Locations: China; BeiJing; Beijing