Supports clinical trial execution by maintaining trial master files, updating clinical trial registries, assisting with regulatory submissions, managing study documentation, tracking site activities, preparing materials, and supporting inspection readiness. The role requires strong organization, communication, attention to detail, Microsoft Office proficiency, and familiarity with clinical research procedures, ICH-GCP, regulatory documents, electronic data capture systems, and responsible AI tools.
Use Your Power for Purpose
At Pfizer, our Worldwide Medical and Safety colleagues are pivotal in bridging evidence-based medical decision support with stakeholders to enhance health and treatment outcomes. Whether you are developing frameworks to ensure our evidence is scientifically robust, offering unbiased and medically essential expertise, or exploring ways to address data gaps, our mission remains clear: to empower healthcare decisions regarding the safe and appropriate use of medicines for patients. You will play a crucial role in improving patients' lives by ensuring the accuracy and integrity of clinical data. Your work will directly impact the development of new treatments and therapies, helping to bring innovative solutions to patients in need.
What You Will Achieve
In this role, you will:
Here Is What You Need (Minimum Requirements):
Bonus Points If You Have (Preferred Requirements):
EEO (Equal Employment Opportunity) & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, or disability.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers .
Medical
At Pfizer, our Worldwide Medical and Safety colleagues are pivotal in bridging evidence-based medical decision support with stakeholders to enhance health and treatment outcomes. Whether you are developing frameworks to ensure our evidence is scientifically robust, offering unbiased and medically essential expertise, or exploring ways to address data gaps, our mission remains clear: to empower healthcare decisions regarding the safe and appropriate use of medicines for patients. You will play a crucial role in improving patients' lives by ensuring the accuracy and integrity of clinical data. Your work will directly impact the development of new treatments and therapies, helping to bring innovative solutions to patients in need.
What You Will Achieve
In this role, you will:
- Coordinate and support clinical trial activities, assisting managers in their execution.
- Contribute to project tasks and milestones, organizing work to meet deadlines.
- Work in a structured environment using established procedures, seeking guidance from colleagues.
- Maintain the Pfizer Trial Master File (PTMF) in compliance with ICH-GCP and SOPs, and ensure team members update tracking and files as needed.
- Timely update trial and site information in the Corporate Clinical Trial Registry and support Clinical Trial Applications to ethics committees and regulatory authorities.
- Provide administrative support for protocols and Informed Consent Documents (ICD) to global Project Managers and Study Managers, assisting with activities within set timelines.
- Develop and maintain local tracking spreadsheets for study-related documents, data, and activities, prepare supportive materials for sites, attend training programs, and identify process improvements for inspection readiness and PTMF compliance.
Here Is What You Need (Minimum Requirements):
- BA/BS with any years of experience
- Demonstrated ability to introduce new ideas and knowledge on all relevant Standard Operating Procedures
- Ability to prioritize multiple tasks and develop strategies for the completion of all required activities
- Strong organizational skills and attention to detail
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)
- Excellent written and verbal communication skills
Bonus Points If You Have (Preferred Requirements):
- Experience in the management of clinical trial and regulatory documents
- Solid understanding of International Conference on Harmonization Good Clinical Practices and local regulations
- Familiarity with applications used in clinical trials
- Experience with electronic data capture systems
- Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use
EEO (Equal Employment Opportunity) & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, or disability.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers .
Medical
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Oversee clinical trial site management, monitoring, activation, and closeout while ensuring patient safety, GCP compliance, data quality, and regulatory readiness. Mentor CRAs, resolve complex site issues, manage CAPAs and quality events, support inspections, oversee investigational products and safety reporting, and contribute to process improvements and feasibility activities. The role requires substantial regional travel and collaboration with cross-functional clinical teams.
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