Clinical Trial Manager China/APAC

Location China
Discipline: Marketing
Job type: Permanent Full Time
Job ref: 001802
Published: 3 months ago

In this role, you will be responsible for the clinical research activities on Rayner ophthalmic medical products within the Eye Science Team, in China-APAC region. These include planning, managing, and executing of Rayner manufacturer sponsored clinical trials for the registration purposes, PMCF and marketing studies and providing oversight and support for Investigator Initiated trials and commercial evaluations to support the management of Rayner ophthalmic solutions and clinical research activities across the Rayner surgical business.

Core Responsibilities

  • Overall responsibility of Sponsored clinical trials design and management for NMPA submissions. Support of IIT/IISR ophthalmic clinical trials in China and APAC region. Ensuring that the studies are appropriately designed, timely approved, monitored and successfully executed.
  • Developing and maintaining of trials documentation (CIP, Investigator Brochure, ICF, eCRFs, Accountability Log, TMF, etc. in compliance with actual requirements, standards, specifications regulations, and guidelines, as  IMDRF/GRRP WG/N47 China GCP regulation for Medical Devices, (announcement 28, 2022); ISO 14155:2020.
  • Active support and management of CROs in trials approval applications, communication and reporting to Institutional Review Boards, Competent Authorities, sites monitoring and overall trial conduction to timely identify, and evaluate issues, proactively recommend solutions to ensure studies approvals and compliance to the national, regulatory requirements, studies objectives and timelines.
  • Driving trials management and clinical operations by identifying, and effectively controlling risks and opportunities in a clinical trials environment
  • The overall efficient day-to-day management of the trials/vendors. Training trial sites on CIP requirements, ISO 14155:2020.
  • Provision of clinical/regulatory expertise to Rayner Eye Science team for the development of clinical trial documents and SOPs
  • Assist with clinical trial budget planning and vendors selection and contracts development. Communicate and manage vendors to ensure quality, studies timelines, and objectives.
  • Coordinating various clinical projects across different vendors.
  • Liaising with key stakeholders, internally and externally. Communication and providing clinical support and expertise to Marketing, RnD, Regulatory and Quality teams, ophthalmic society KOLs, and research organizations.

Competencies

  • Motivation: Displays energy and enthusiasm in approaching the job. Commits to putting in additional effort. Maintains high level of productivity and self-direction. Learning, Results and Quality oriented.
  • Clinical competence: Knowledge and experience in medical devices clinical trial design and process. Medical Writing.
  • Planning & Organizing: Manages the projects, plans and organizes tasks and work responsibilities to achieve objectives and meet timelines. Sets priorities. Schedules activities. Allocates and uses resources properly
  • Teamwork: Interacts with people effectively, openly. Able and willing to share and receive information, develop trust and integrity with team crew.
  • Communication: Communicates effectively, listens sensitively, adapts communication to audience and fosters effective communication with internal and external stakeholders
  • Adaptability: Adjusts to changing and fast-paced environments whilst maintaining effectiveness
  • Commercial Awareness: Understands and keeps up to date with the international ophthalmic industry and business in general, including marketing trends, customer demographics, technical advances, and the successes and failures of competitors.

Skills & Experience Required

Essential 

  • Degree in medical, natural, technical or life science or health related field.
  • Demonstrated at least 5 years’ experience in clinical research and clinical project management at CRO or Medical Device manufacturer environment. Solid understanding of medical devices clinical trial regulations, international standards methodology.  
  • Strong project management expertise. Ability to travel
  • Excellent English and Mandarin Chinese writing and communication skills.
  • Self-driven, accountable, and collaborative team player

Desirable 

  • Ophthalmology, Project management experience
  • IOLs experience, knowledge of ANSI Z80.x ISO 11979-7 clinical requirements
  • Experience in statistical analysis and data interpretation