In this role, you have the opportunity to
Lead the clinical evaluation projects across the product lines, work closely with regulatory affairs team and marketing team to develop robust and rational clinical evaluation strategy; Ensure the clinical evaluation projects successfully accomplished on time and on quality;
As Medical monitor to provide a medical assessment for the adverse events reported within clinical trial.
To manage investigator-initiated study (IIS) as medical affairs expertise and ensure the research proposal is discussed within the local clinical trial review committee.
To provide strategic medical support to the clinical operation team on the medical activities related to the conduct of a trial.
You are responsible for
Proactively address possible risks for study data for regulatory submission and effective communication of risks if applicable;
Satisfaction level from CFDA for clinical evaluation report and clinical trial documentation or data;
Demonstrate subject matter expertise for clinical evaluation and clinical trial data interpretation;
Develop Clinical Evaluation Report (CER) per needs;
Ensure all the company-sponsored studies executed in compliance with GCP, related regulations, Philips harmonized clinical SOPs in terms of quality and timeframe;
Ensures the clinical study successfully complete on time and on budget;
Ensures the clinical study in high quality and compliant to Philips harmonized clinical SOPs and local regulation;
Ensures the clinical study can withstand audit scrutiny by internal clinical trial audit or Regulatory entity where the risk of failure can affect product registration;
Ensures that all internal and external collaborating staff are appropriately organized, trained and managed to execute the terms of a research project per protocol and to ensure study and data integrity in support of a broader Clinical Evidence Strategy;
Actively interfaces with various internal and external stakeholders including clinical science teams, internal customers, Regulatory, Legal, Quality, CRO/vendor staff, Key Opinion Leaders and clinical research staff as the subject matter expert for clinical GCPs;
Proactively identifies and independently prepares high quality clinical trial execution, project management, and reporting documentation (Protocol, Investigator Brochure and Inform Consent Form).
You are a part of
Great China Q&R team
To succeed in this role, you should have the following skills and experience
Master or PhD in medicine or life science education background;
At least 2 years in Clinical Evaluation;
Demonstrated expertise in CFDA regulatory requirements and data interpretation;
Demonstrated expertise in GCP for the conduct of research involving human subjects is required;
Effective organizational, communication, and project team skills;
Experience in developing and /or implementing Clinical Research SOPs in an industry setting;
Prefer 3-5 years Medical affairs experience in medical device company.