Job Purpose:
To ensure the clinical projects working smoothly, make and implement project management effectively.
Responsibilities:
- Make project management plan: To draft and implement feasible project management plan according to SOPs, GCP Guidelines and study protocol. Conduct project according to the project management plan.
- Make monitoring plan: To draft and implement monitoring plan according to SOPs, GCP Guidelines and study protocol. Conduct project according to the monitoring plan.
- Participate in site selection, initiation, monitoring, and closeout activities.
- Customer Maintain: Keep positive relationship with sponsors and investigators.
- Provide guidance and training to project team or to CRA team in special cases.
- Other work for clinical operation department: drafting SOP, internal training, clinical research or marketing research questionnaires, translate document verification, 3rd Party evaluation, support company system auditing, etc.
Qualifications:
- Bachelor degree or above in Medical, Pharmacology or Biology related major. The excellent candidates will not be restricted to the current requirements.
- Adequate knowledge of new product development, including local regulation, ICH-GCP, clinical trial operations. Got GCP certificate.
- At least 5 years clinical trial experience, at least 3 years of project management experience, CRO working experience is preferred.
- Fluent in both written and conversation English.
- Excellent command of Microsoft offices.
- Strong project management skill; Strong time management skill.
