Clinical Study Operations Specialist
4 days ago
We are seeking a skilled Clinical Study Team Assistant to join our team at Pfizer. The successful candidate will play a key role in connecting evidenced-based medical decision support with colleagues and stakeholders to enable better health and treatment outcomes.
About the RoleThe primary focus of this position is to facilitate clinical trials, monitor their progress, and coordinate all supporting activities. This involves working closely with managers to achieve project goals and objectives, while maintaining Pfizer's Trial Master File (PTMF) in accordance with International Council for Harmonization - Good Clinical Practice (ICH-GCP) and Standard Operating Procedures (SOPs).
This role requires strong organizational skills, attention to detail, and excellent communication abilities to build collaborative relationships with internal and external stakeholders.
Key Responsibilities- Contribute to the completion of project milestones and organize work to meet project deadlines.
- Maintain PTMF in accordance with ICH-GCP and SOPs.
- Review shared spaces to ensure others are updating tracking and files as requested by the team.
- Update trial and site information in Corporate Clinical Trial Registry in a timely manner.
- Support and coordinate Clinical Trial Applications to ethics committees and regulatory authorities, if applicable, to obtain approval within required timelines.
- Provide administrative support for protocol and Informed Consent Document (ICD) to global Project Managers and Study Managers.
- Support and coordinate other activities as requested by PMs/SMs and assigned within required timelines.
- Bachelor's Degree.
- Relevant work experience in a health-related discipline, pharmaceutical or medical research.
- Demonstrated ability to introduce new ideas.
- Knowledge of relevant SOPs.
- Ability to prioritize multiple tasks and develop strategies for completion of all required activities.
$73,400 - $100,500 per year, depending on location and experience.
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