Project Manager (FSP)
Primary Location: China, Remote 求人ID R0000034576 Category Clinical TrialsAbout this Role
Key Accountabilities:
Study Team Management
- According to the requirements of the client and the project team, formulate a reasonable project management plan to ensure that the clinical trial is strictly implemented in accordance with the time plan, research protocol, SOP, and relevant laws and regulations.
- Organize/assist in holding project meetings, including internal/external meetings of the company, such as: weekly project meeting, monthly project meeting, researcher meeting, center launch meeting, data review meeting, project summary meeting, CDE on-site inspection and other possible meetings.
- Cooperate with colleagues in QC and QA departments to carry out quality control and audit work, prepare before quality control/audit, communicate during quality control/audit, rectify after quality control/audit, and any quality related work.
- Guide the daily work of the CRA, supervise the implementation of the work of the CRA, and evaluate the work performance of the CRA.
- According to the SOP of the sponsor, determine the form documents needed to be used in the process of clinical trial, such as screening and enrollment form, identification code form, drug/material handover form, etc.
- Cooperate with other functional departments of sponsor to carry out related work, and maintain efficient and effective communication with functional departments in the process of carrying out the experiment.
- Establish a good cooperative relationship with research centers and investigators to promote recruitment.
- Complete other tasks assigned by superior leader in time.
Compliance with Parexel standards
- Comply with required training curriculum.
- Complete timesheets accurately as required.
- Submit expense reports as required.
- Update CV as required.
- Maintain a working knowledge of and comply with Parexel processes, ICH-GCPs and other applicable requirements
Skills:
- Proven organizational and presentation skills.
- Ability to manage multiple tasks and meticulous attention to detail.
- Agile & quick learner, good team player
- Willingness and ability to train others on study administration procedures.
- Excellent written and verbal communication skills.
- Good written and spoken English.
- Computer Proficiency: ability to handle daily work via Microsoft Word, Excel, PowerPoint, and Outlook, etc.
Knowledge and Experience:
- Minimum 1.5 years’ experience of project management.
- 7 years’ experience in life science or related fields.
- GCP certificate.
- Fluent in English and Mandarin (preferred).
- Global trial experience preferred.
- FDA and (or) EMA inspection experience preferred.
Education:
- Bachelor’s degrees or above of clinical medicine, pharmacy, life science or related majors.
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