Global RWE Research Coordinator

4 weeks ago


Shanghai, Shanghai, China Costello Medical Full time
About the Role

We are seeking an experienced and proactive individual to enhance our study setup capabilities, including ethics applications and site support, in our Shanghai office.

This is an exciting time to join the Costello Medical team as we expand in Shanghai, Singapore, and internationally. You will work closely with our experienced global team, including colleagues in Singapore who deliver work for clients in China, and colleagues in our UK offices.

You will receive one-to-one training on technical aspects of the role, including project management and effective client communication. Delivering project work requires close collaboration with clients, and following a successful induction period, you will increasingly participate in meetings with external stakeholders.

Key Responsibilities
  • Ethics and Regulatory Compliance:
    • Prepare and submit ethics applications and other regulatory documents to ensure compliance with local and international regulations.
    • Maintain up-to-date knowledge of regulatory requirements and ensure all studies adhere to these standards.
  • Data Management and Analysis:
    • Oversee data collection, entry, and management for studies conducted in China, ensuring accuracy and completeness.
    • Collaborate with statisticians and analysts to perform data analysis and prepare comprehensive reports of study findings.
  • Study Coordination and Management:
    • Coordinate the design, execution, and reporting of RWE studies specific to the China market.
    • Manage project timelines, resources, and deliverables to ensure high-quality and timely completion of projects.
  • Site Setup and Support:
    • Identify and coordinate with clinical research sites in China, ensuring all necessary infrastructure and protocols are in place.
    • Facilitate smooth setup and ongoing support for the duration of the study.
  • Training and Development:
    • Advise clients and internal members of the project team to ensure that best practices and industry standards are adhered to, including completing and advising on external trainings to ensure Costello Medical's compliance with the latest best practice.
    • Create and deliver internal training to support others in developing their expertise in RWE and Market Research studies.
  • Help maintain a positive, friendly, and collaborative environment within the company.
  • Contribute to the wider aims of the company wherever possible and aligned to individual interests.
Requirements

To succeed in this role, you should have:

  • A minimum of 1-3 years of experience in clinical research or a related field, with a focus on study set-up, ethical approval, and project management.
  • Prior experience of working in investigator site management, including conducting monitoring visits, from either a pharmaceutical company or a CRO environment.
  • Familiarity with the China market is desirable. Experience in additional markets would be beneficial.
  • A degree-level qualification in a scientific discipline (minimum second upper honours, GPA 4/5, CAP 4/5 or equivalent).
  • A comprehensive understanding of RWE or clinical research methods and study designs, with a willingness to further develop this knowledge.
  • Experience in working collaboratively within a team and supporting the development of junior colleagues or team members.
  • Strong organisational skills with the ability to manage multiple tasks and ensure timely delivery of projects.
  • The capacity to maintain exceptional customer service and quality of deliverables under multiple competing demands.
  • An exceptional written and spoken fluency in Mandarin (equivalent to native Mandarin language skills) and excellent written and spoken fluency in English in order to deliver client work across Asia, with a focus on China.
  • Strong scientific writing skills with the ability to tailor writing style to different audiences.
  • Experience in communicating directly with clients, including responding to different communication styles, as well as a proven ability to build robust and sustainable client relationships.
What We Offer
  • A competitive starting salary of RMB 14,000 per month, which may be negotiable based on experience.
  • 14 days' annual leave plus public holidays.
  • Flexible benefits scheme offering additional holiday, cash payments, and wellbeing benefits.
  • Employer contributions to five social insurances and housing fund.
  • Paid study leave and funding for external qualifications.
  • Comprehensive travel insurance.
  • Flexible working hours.
  • Regular company-funded social activities.


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