How You Will Achieve It

• Process TMF documents received per good documentation practices, TMF readiness critieria and other reference documents
  • Demonstrate understanding of document types, properties and indexing requirements
  • Ensure overall TMF quality in terms of document completeness, indexing and scanning accuracy
  • Process documents in the TMF system(s) within specified timelines, based on document criticality/priority
  • Communicate document inquiries with responsible users as needed
• Liaise with Document Owners, TMF Study Owners and/or other end users to resolve document related discrepancies and issues
• Communicate and escalate issues to the TMF Document Specialist Lead and TMF Operations when needed
• Contribute to process improvement initiatives and projects that may arise
• Can be identified as Subject Matter Expert for TMF process, systems and related tools, where applicable

Qualifications

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

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.