Associate Data Manager, Clinical Data Sciences

Pfizer, S.A. de C.V; Chennai District; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Pfizer India is seeking an Associate Data Manager in Clinical Data Sciences to ensure the accuracy and integrity of clinical data across studies. You will support data monitoring and management, review data, manage queries, and investigate logic checks to maintain data quality.

You will collaborate with study teams, document owners, and TMF study owners; adhere to SOPs; contribute to process improvements, and leverage CTMS and electronic data management tools to support trial activities.

Qualifications

• BA/BS degree and any years of experience.
• Experience with ICH/GCP documentation requirements.
• Hands-on with electronic/documentation management systems.
• Understanding of clinical development and GCP principles.
• Knowledge of regulatory requirements and data standards.
• Strong English written and spoken communication.
• Proficient in Microsoft Office.

Responsibilities

• 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 CTMS questions and issues.
• Adhere to SOPs and working practices.
• Collaborate with Study Team Points of Contact, Document Owners, and TMF Study Owners to resolve document-related issues.
• Contribute to process improvement initiatives and additional projects.

Skills

English proficiency

Documentation management

Data management systems

ICH/GCP knowledge

Regulatory knowledge

Education

BA/BS degree

Tools

CTMS

EDMS / Web-based DMS

Job description

Associate Data Manager, Clinical Data Sciences

We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place.

To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.

Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life-changing medicines to the world.

Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.

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

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

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