Clinical Data Management Associate

Pfizer Ltd; Chennai; Hybrid; INR 600,000 - 1,000,000; Full time

Job summary

Pfizer Ltd is seeking an Associate Database Analyst in Clinical Database Management in Chennai. You will ensure clinical data accuracy, support CTMS questions, and uphold SOPs while collaborating with study teams to resolve discrepancies and drive process improvements.

The role emphasizes data quality, regulatory literacy, and strong English communication within a hybrid work setup in India.

Qualifications

• BA/BS with any years of experience.
• Experience with ICH/GCP documentation requirements.
• Hands-on with electronic documentation management systems or web-based data management systems.
• Understanding of the clinical development process and GCP principles.
• Knowledge of regulatory requirements and data standards.
• Strong written and spoken English communication skills.
• Proficiency in Microsoft Office Suite.

Responsibilities

• Engage in data monitoring and management activities including data review and query management.
• Investigate logic check flags and ensure data quality during CDM processes.
• Serve as first point of contact for CTMS questions and issues.
• Adhere to SOPs and working practices; support TMF and document handling.
• Collaborate with study teams and owners to resolve discrepancies.
• Contribute to process improvements and additional projects.

Skills

English communication

Microsoft Office

Clinical data management

Data management systems

Regulatory knowledge

ICH/GCP documentation

Clinical development process

Team collaboration

Education

BA/BS in any field

Tools

CTMS experience

Data validation

AI tool familiarity (ChatGPT/Copilot)

Job description

Associate, Associate Database Analyst, Clinical Database Management

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.

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

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 Experience Level Mid Level