Clinical Study Team Assistant

4 weeks ago


Wuhan, Hubei, China Pfizer Full time

Empowering Healthcare Decisions

Pfizer Worldwide Medical and Safety colleagues play a key role in connecting evidence-based medical decision support with colleagues and stakeholders to enable better health and treatment outcomes.

As a Clinical Study Team Assistant, you will facilitate the conduct of clinical trials and monitor their progress. You will coordinate all activities that support the clinical trials and assist managers in conducting them.

Key responsibilities include:

  • Contribute to the completion of project milestones and organize own work to meet project task deadlines.
  • Maintain the 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 trial and site information as necessary in the Corporate Clinical Trial Registry in a timely manner.
  • Support and coordinate the Clinical Trial Application to ethics committees and regulatory authorities, if applicable, to obtain approval within required timelines.
  • 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/local tracking spreadsheets for study-related documents, data, activities, and prepare site supportive material.
  • Attend appropriate training programs and project teleconferences as applicable.
  • Assist the 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.

Requirements

Must-Have

  • Bachelor's Degree
  • Relevant work experience in a health-related discipline, pharmaceutical, or medical research
  • Demonstrated ability to introduce new ideas
  • Knowledge of 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 the management of clinical trials and/or regulatory documents
  • Knowledge of International Conference on Harmonization Good Clinical Practices and local regulations
  • Knowledge of applications used in clinical trials

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



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