RESPONSIBILITIES:

Provide technical support for HCP initiated clinical study

• Make appropriate product and procedural recommendations and work closely with doctor/patient related issues for the safety of the devices and clinical study activities.
• Ensure high-quality scientific communication with local and regional Leading Opinion Leaders or Specialists on a peer-to-peer basis.
• Work with society for clinical standard of care development and support establishment of clinical consensus and guideline
• Support local KOLs and PIs to develop IIS protocols and facilitate approval process management.

Collaborate with Mkt and Sales team to conduct the Product and Therapy promotion

• Work with education and marketing to develop training curriculum and formalize a unified training process for both internal employees and external customers.
• Educate customers together with sales and marketing on procedure process management and ensure compliance with implementation of the procedure flow
• Formulate the ideation/concept together with KOLs for market shaping and advocating the concept of therapy together.
• Define and develop activities and program to promote and localize therapy by partnering with sales and marketing hospital by hospital

Lead/design and track Abbott initiated clinical study

• Process owner for Investigator Sponsored Studies and Manages Global Investigator Sponsored Studies covering both Global ISS and Regional ISS across CRM Division, including but not limited to global, regional, and country studies.
• Act as a liaison with physicians throughout the study conduct where local medical affairs are not available
• Provide medical | clinical oversight for on-market product and product performance functions, including review, and monitoring of investigator sponsored studies, coordination of professional education, and collaboration with physicians on publication of research on CRM on-market products
• Write and update SOPs for the conduct of ISS on one site or multi-site in one country or cross country.
• Collaborate with R&D to review R&D initiated ISS involving Medical Affairs interface
• Provide strategic guidance for the performance of clinical studies related to product development and commercial/marketing activities.

Other Skills:

• Impact and influence: Develop and use effective strategies to influence others or to gain their support.
• Open communication and listening: Ensures an accurate understanding and act in a way that facilitates open exchange of ideas and information.
• Organizational awareness: Understands the agendas and perspectives of others; able to recognize and effectively balance the interests and needs of one’s own group with those of the broader organization.
• Planning and organizing: Effectively identify, plans, schedules and co-ordinates the resources (people, material, information, time) required to accomplish your goals.
• Computer Skills
• Experience using Microsoft Office Suites i.e. Word, Excel, PowerPoint

EDUCATION REQUIREMENT:

• Education: PhD
• Years of experience, both overall and any industry-specific experience needed: 5+ years in clinical research and education within the medical device industry, specifically managing sponsored trials and IIT processes.
• Other qualifications/certifications:
• Expertise in cardiology (e.g., EP, CRM…). Proven ability to manage clinical study initiation, monitoring, and data analysis.
• Brady, ICD, CRT 三级认证 + DRC+10