Founded in 1849, Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support.
Post : Associate Data Manager - Clinical Data Sciences
• 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.
• 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
• Experience in management of medical and clinical study records and documentation
Qualification : Bachelor's Degree
Location : Chennai
Industry Type : Pharma/ Healthcare / Clinical research
Functional Area : Medical Review Services
End Date : 20th April, 2021
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