TMF SO Associate

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

• Engage in Data Monitoring and Management (DMM) activities including data review query management and investigating logic check flags.
• Ensure the quality of database design through documentation testing validation and implementation of clinical data collection tools or systems.
• Serve as the first Point of Contact for customers needing assistance with Clinical Trial Management System (CTMS) questions and issues.
• Adhere to applicable Standard Operating Procedures (SOPs) and working practices.
• Collaborate with Study Team Points of Contact Document Owners and Trial Master File (TMF) Study Owners to resolve document-related discrepancies and issues.
• Contribute to process improvement initiatives and additional projects as they arise.

Here Is What You Need (Minimum Requirements):

• BA/BS with any years of experience
• Demonstrated experience of ICH/GCP (International Council for Harmonization/Good Clinical Practice) documentation requirements
• Hands-on experience with electronic documentation management systems and/or web-based data management systems
• Awareness of the clinical development process including a deep understanding of the principles of Good Clinical Practice
• Solid grasp of regulatory requirements and relevant data standards
• Strong oral and written English communication skills
• Proficiency in Microsoft Office Suite

Bonus Points If You Have (Preferred Requirements):

• Experience with clinical trial management systems (CTMS)
• Familiarity with data validation and quality control processes
• Ability to work collaboratively in a team environment
• Strong problem-solving skills and attention to detail
• 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 includingrisk management and ethical use

Pursuant to Article 24(6) of the Act of June 24 2024 on the protection of whistleblowers Pfizer Polska Sp. z o.o. and Pfizer Trading Polska Sp. z o.o. declare that they have adopted a joint internal reporting procedure which in accordance with the provisions of the aforementioned Act is also available to persons applying for employment on the basis of an employment relationship or other legal relationship constituting the basis for providing work or services or performing functions. The content of the procedure is made available upon request sent to the contact person or to the email address