Support clinical data monitoring and management by performing data review, query handling, logic-check investigations, documentation testing and validation, and CTMS first-line support. Ensure compliance with ICH/GCP and regulatory data standards, collaborate with study teams and TMF owners to resolve discrepancies, and contribute to process improvements and projects.
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
Here Is What You Need (Minimum Requirements):
Bonus Points If You Have (Preferred Requirements):
Work Location Assignment: Hybrid
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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
- 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, including risk management and ethical use
Work Location Assignment: Hybrid
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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
Pfizer Chennai, Tamil Nadu, IND Office
Chennai, India
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