Hybrid Data Manager

at Pfizer

• Job title: Data Manager
• Job type: Full Time
• Experience level: Junior, Mid level
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Thessaloniki, Greece

About the role

• Associate Data Manager responsible for clinical data review and query management at Pfizer. Ensuring data integrity and collaboration within the team for operational excellence.

Responsibilities

• Participate in CDIS activities including data review and query management.
• Assist with quality database design including documentation, testing, validation, and implementation of clinical data collection tools, CRF and non-CRF, using an electronic data capture (EDC) system and/or other data collection systems.
• Ensure work carried out in accordance with applicable SOPs and working practices.
• Ensure the required study-specific CDIS documents in the Trial Master File (TMF) are of high quality and are filed contemporaneously to support downstream inspection and submission readiness activities.
• Ensure operational excellence in collaboration with Data Manager and Clinical Data Scientist for application of standards, data acquisition, proactive data review and query management, data cleaning, e-data processing, data access and visualization, DM metrics reporting, database release, and submission related activities.

Requirements

• Bachelor’s degree minimum requirement.
• Minimum 1-3 years Data Management experience required.
• Strong knowledge / understanding of clinical development and pharmaceuticals as a regulated industry.
• Strong knowledge / understanding of healthcare regulatory authorities (e.g. FDA, Health Canada).
• Ability to learn clinical data management processes and principles in area of responsibility.
• Demonstrates required verbal and written communication skills including ability to communicate remotely.
• Capable to learn technical data systems.
• Capable to learn how to use data visualization tools (e.g. Spotfire, J-Review).
• Awareness of MedDRA/WHO-Drug preferred.
• Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.)

Benefits

• Health Sciences experience or Technology degree preferred.
• Strong knowledge / understanding of clinical development and pharmaceuticals as a regulated industry.
• Strong knowledge / understanding of healthcare regulatory authorities (e.g. FDA, Health Canada).
• Ability to learn clinical data management processes and principles in area of responsibility.
• Demonstrates required verbal and written communication skills including ability to communicate remotely.
• Capable to learn technical data systems.
• Capable to learn how to use data visualization tools (e.g. Spotfire, J-Review).
• Awareness of MedDRA/WHO-Drug preferred.
• Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.)