Associate Data Manager Jobs in Pfizer - Chennai

Job Description

Responsibilities:

• Contribute to completion of project milestones and organize own work to meet project task deadlines.
• Participate in Data Monitoring and Management (DMM) activities including data review and query management.
• Ensure quality database design including documentation, testing, validation, and implementation of clinical data collection tools, and/or other data collection systems.
• Serve as the first Point of Contact for customers needing assistance with Clinical Trial Management System (CTMS) questions and issues.
• Ensure work is carried out in accordance with applicable Standard Operating Procedures (SOPs) and working practices.
• Investigate logic check flags, utilizing system information, as well as applicable study documentation.
• Liaise with Study Team Point of Contact, Document Owners, Trial master file (TMF) Study Owners and/or other end users to resolve document related discrepancies and issues.
• Identify and investigate any potential discrepancies and review findings with the study team Point of Contact to verify.
• Contribute to process improvement and additional project that may arise.

Qualifications/ Skills:

Must Have

• Bachelor's Degree
• Demonstrated experience or knowledge 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 clinical development process including knowledge and understanding of the principles of Good Clinical Practice
• Understanding of regulatory requirements and relevant data standards
• Consistent, detail-oriented, and dedicated to excellence
• Strong oral and written English communications skills
• Proficiency in the use of Microsoft Office Suite of tools

Nice to Have

• Experience in management of medical and clinical study records and documentation