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Clinical Study Team Assistant
2 months ago
About the Role
Pfizer Worldwide Medical and Safety colleagues play a pivotal role in connecting evidence-based medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating frameworks 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.
Key Responsibilities
- Facilitate the conduct of clinical trials and monitor their progress.
- Coordinate all activities that support the clinical trials and assist managers in conducting them.
- 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 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 or 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 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
- 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
Preferred Qualifications
- Experience in management of clinical trial and/or regulatory documents
- Knowledge of International Conference on Harmonization Good Clinical Practices and local regulations
- Knowledge of applications used in clinical trials
