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.
Role Summary: As part of R&D, the Clinical Project Manager (CPM) will plan, monitor, and deliver clinical research studies at external trial sites in compliance with Good Clinical Practice, Standard Operating Procedures, and Corporate Policies, Guidelines and Standards.
Essential Responsibilities: As such, individual will have extensive cross-functional interaction within the Company, ranging from R&D to medical and regulatory functions at global and local levels. In this role, CPM will be responsible for insuring the highest standards of patient-driven quality are instilled in the Organization more specifically when conducting clinical activities. 1. Prepare and define the project scope of work, including costs, budgets and deliverables 2. Participate in selection process of external Service Providers (SPs) 3. Build a general understanding of our SPs, their organization and capabilities to anticipate opportunities and risks 4. Translate technical requirements from R&D project teams into scope of work for execution by SPs. 5. Build strong relationships to maximize performance and value delivered by SPs 6. Create a culture of joint accountability to ensure Vendor performance 7. Develop, maintain and share Good Vendor Management Practices 8. Facilitate efficient and collaborative resolution of problems and conflicts with SPs and on behalf of SPs within Life Sciences. 9. Facilitate final quality check for all operational processes associated with specific engagements and accountable for aligning engagement deliverables to GEHC policies and procedures for operations, compliance, and outsourcing 10. Facilitate vendor training on applicable GEHC SOPs 11. Coordinate with internal staff to ensure smooth support of the project 12. Performs initial contact and participates in the assessment and selection of qualified investigators for inclusion in clinical programs. 13. Performs Pre-Selection, Initiation, Monitoring, and Closeout site visits. 14. Contributes to the preparation of study documentation such as protocols, amendments, Case Report Forms, and study reports 15. Collects and processes regulatory documents and correspondence 16. Negotiates and tracks center/trial budget according to financial agreement with each centre 17. Assists in the tracking of subject enrollment at each trial site, and provides management with detailed reports of clinical activities, as requested 18. Track study deliverables according to plan 19. Interact with key study investigators to establish effective working relationship 20. Coordinate with supply vendor if deemed necessary as per study plan to ensures that clinical trial sites have adequate supplies to perform the trial 21. May have the requirement to supervise the work of more junior Clinical Research Associates, as applicable.
Qualifications/Requirements: 1. Masters degree in a science related field with a minimum of 5 years or B.Sc with 7 years experience with clinical trials management within the healthcare industry 2. Excellent prior knowledge of all aspects of the clinical trial process including planning, execution and reporting/publication of results 3. Proven communication skills, both written and verbal, at all levels of an organization 4. Must be willing to travel as required 5. Excellent process knowledge, experience, and skills 6. Excellent team player with global mindset in a multicultural environment 7. Prior experience working with Microsoft office products (Word, Excel, PowerPoint) 8. Fluent in the main Chinese dialects used in business 9. Fluent both oral and written in English 10. International experience will be a plus 11. Able to drive action, partner and be proactive in engaging all stakeholders, regardless of reporting line.
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