Beijing, CHN
3 days ago
Clinical Development Scientist
Job Description **In this role, you have the opportunity to** + Provide Chinese clinical strategy for NPI; Lead the clinical plans development to be compliance with GCP, the regulation, Philips harmonized clinical SOPs; + Lead the clinical evaluation projects across the product lines, work closely with Regulatory team, product team, marketing team to develop robust and rational clinical evaluation strategy; Ensure the clinical evaluation projects successfully accomplished on time and on quality; + As key scientific reviewer to assess the scientific and ethical of the company sponsor study & IIS; **You are responsible for** + Participate in the evidence generation processes for NPI & LCM + Participate in the CDMA(Clinical Development and Market Access) process + Participate in the development of clinical deliverables, including clinical evaluation reports, clinical trial protocols, CSRs & clinical sections of regulatory submissions + Working closely with Clin Ops and BS&DM on day to day management of assigned clinical studies + Supports clinical literature searches and reviews **To succeed in this role, you should have the following skills and experience** Education: Master or PhD in Biomedical Engineering or medicine. Experience: 3 years’ experience in clinical development function or related clinical area. Competencies and Skills: + Demonstrated expertise in NMPA regulatory requirements and clinical data interpretation; + Effective organizing, communication, and project management skills; + Effective verbal and written skills in both English and Mandarin; + Proficient in Biostatistics software is preferred.
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