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Clinical Research Clinician 〔Hired Through FESCO)

 
岗位信息
  • 更新时间:2016-02-29
  • 学历:本科
  • 工作地点:北京市
  • 语言要求:
  • 工作年限:1年以下
  • 招聘人数:1
  • 月薪:0-0元
  • 性质:
岗位要求
岗位职责:



Reporting to: Scientific & Clinical Affairs Manager

JOB SUMMARY
The Clinical Research Clinician works as trial clinician for local / or regional Ph I-IV clinical studies, and support new product registration and both local and global clinical trials in Pfizer China. The CRC acts as clinical expert, should have good understanding of one or more therapeutic areas in Neurology, AI, Inflammatory, Pain, CNS and related products.

In supporting clinical trials, the CRC is required to prepare protocol synopsis, finalize protocol, to be a clinical lead in a study team, prepare and finalize local clinical study report to support local NDA submission. As regards supporting new product registration, the CRC is required to translate clinical section of submission dossier, respond to Regulatory agency for clinical related queries, prepare slides and deliver presentations for CDE 〔Center of Drug Evaluation) Review Meeting as required.

KEY RESULT AREAS & JOB ACTIVITIES /TASKS
Clinical Research
- Identify and develop research strategies for Pfizer products which in charged for
- Develop appropriate protocol synopsis and protocols to support research proposals and meet local registration needs
- Actively participate feasibilities at program, protocol and site level for global/regional studies, and provide timely and quality feedback
- Translate final protocols and amendments for global/regional studies
- Assist with Study Manager 〔Operational Lead) in Coordinating Principal Investigator and leading site selection
- Develop local ICDs 〔Informed Consent Document), and translate as needed
- Prepare and deliver presentations for product and protocol introduction at Investigators Meeting and answer related questions from investigators
- Review and provide comments on study documents as required
- Act as Protocol Lead and Clinical Lead in a study team, approve protocol deviations, analyze AEs/SAEs, and answer clinical and product queries from investigators
- Provide valuable inputs in SAP 〔Statistical Analysis Plan) finalization and efforts in achieving Database clean
- Prepare and finalize local clinical study report, and assist NDA submission
- Maintain high level of clinical understanding to Pfizer products and INFLAMMATION therapeutic area
- Provide disease and protocol training to monitors as needed
- Establish and maintain an effective network of relationships with key opinion leaders in INFLAMMATION

New product registration
- Translate and prepare clinical section of IND submission dossier 〔e.g. IB, study reports from previous clinical trials, clinical summary)
- Prepare clinical related response to SFDA/CDE for any queries as required
- Prepare slides and deliver presentations of clinical section to CDE Review Meeting as required

EDUCATION & EXPERIENCE REQUIREMENTS
Educational / Training
University Degree and Medical qualification
Advanced Degree in biomedical sciences 〔MSc, PhD) preferred
Working Experiences
At least 3 years clinical experience, AI and / or neuroscience working experience is more preferred.
At least 2 years international pharmaceutical industry experience
Experiences in assigned therapeutic areas is preferred
Knowledge of Chinese/ICH GCP guidelines and Pfizer SOPs
Knowledge on drug development process
Knowledge of clinical trial methodology
Knowledge of country regulatory environment
Proficiency in Basic Microsoft Word, Outlook, PowerPoint and Excel

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