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工作職責(zé):
Why Patients Need You
Pfizer Worldwide Medical and Safety colleagues play a key role in connecting evidenced based, medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating framework necessary to ensure our evidence is scientifically sound, providing unbiased, medically necessary expertise or investigating how to close gaps in data, our mission is simple. Empower healthcare decisions regarding the safe and appropriate use of medicines for patients.
What You Will Achieve
You will facilitate in conducting clinical trials and monitoring their progress. You will coordinate all activities that support the clinical trials and assist the managers in conducting them. As an associate, your focus on the job will contribute in achieving project tasks and goals.
It is your hard work and focus that will 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.
任職資格:
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
? Stong technical skills. Good at Excel, Power automate, Spotfire