Clinical Development Manager
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 RA&Clinical&Medical team, based at Shanghai and report to Senior Clinical Development Senior Manager.
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.
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