Clinical Study Team Assistant -临床试验团队助理专员

ill help in making Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

• Contribute to completion of project milestones and organize own work to meet project task deadlines.

• Maintain Pfizer Trial Master File (PTMF) in accordance with International Council for Harmonization - Good Clinical Practice (ICH-GCP) and Standard Operating Procedures (SOPs).

• Review shared space to ensure others are updating tracking and files as requested by the team.

• Update the trial and site information as necessary in Corporate Clinical Trial Registry in a timely manner.

• Support and coordinate the Clinical Trial Application to ethics committee and regulatory authority, if applicable, to obtain approval within required timeline.

• Provide protocol and Informed Consent Document (ICD) Administrative Support to global Project Managers and Study Managers.

• Support and coordinate any activities as requested by PMs/SMs and as assigned within required timelines.

• Maintain / develop local tracking spreadsheets for study-related documents, data, activities and prepare site supportive material.

• Attend appropriate training programs and project teleconferences as applicable.

• Assist team with the preparation of any documents or tracking and updating information.

• Identify and implement process improvements for inspection readiness, Pfizer Trial Master File (PTMF) compliance, Investigator Meeting organization.

• Ensure the reconciliation of Trial Master File and the Site Master File on a periodic basis.

Qualifications

Must-Have

• Bachelor's Degree

• Relevant work experience in a health related discipline, pharmaceutical or medical research

• Demonstrated ability to introduce new ideas

• Knowledge on all relevant Standard Operating Procedures

• Ability to prioritize multiple tasks and develop strategies for completion of all required activities

• Ability to build collaborative working relationships with colleagues and associates both within and external to the organization

Nice-to-Have

• Experience in management of clinical trial and/or regulatory documents

• Knowledge of International Conference on Harmonization Good Clinical Practices and local regulations

• Knowledge of application used in the clinical trials

Work Location Assignment: On Premise

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Medical

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