Clinical Research, Senior Manager
Location Hong KongFULL_TIME
Consultant Polly Lam
Date posted 22 September 2022hong-kong tech-transformation/data-science-big-data 2022-09-22 2022-11-21 science-and-research Hong Kong HK Robert Walters https://www.robertwalters.com.hk https://www.robertwalters.com.hk/content/dam/robert-walters/global/images/logos/web-logos/square-logo.png
Our client is a world leading medical technology company, looking for a clinical leader to join their team.
- Lead and oversee the execution for both local & global studies and clinical research projects; set clear direction and coach the team to align with defined practices and policies according to clinical objectives.
- Be the owner of assigned research projects, including project planning, regular progress updates, experimental schedules development, resources evaluation, product design and process review, laboratory daily operation and maintenance, experimental data tracking and analysis, performing experiments, result reporting, hitting critical deadlines, project performance and risk management, administration, financial management, budgeting, and issue resolution, etc
- Be responsible of the whole process of regulatory submission including regulatory strategies development and implement to obtain timely product approvals form worldwide regulatory bodies
- Work closely with internal parties including but not limited to Clinical, Quality, Medical Safety and Medical Affairs and Regulatory Affairs to ensure program execution to achieve business goals within regulatory requirements.
- Work within established teams to provide clinical subject matter expertise (familiarity with OU clinical strategies, pre- and post-market evidence needs, product positioning, study design approaches, including endpoint and product performance goal definitions), operational aspects of clinical trials in in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations
- Establish and maintain a strong network and close relationship with the various internal and external parties.
- PhD/ doctoral degree in Biochemistry, Bio Science, Biomechanical Engineering or relevant fields
- Over 10 years of experience in hands-on clinical research
- Familiar with ISO 13485 design control process requirements is preferred
- Management experience in technical field is preferred
- Strong leadership capabilities with Can-Do attitude, strong communication skills, detail-minded and hard-working person to maintain high standard of assigned projects
- Excellent written and oral communication skills in English and Mandarin
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