Pfizer is a global pharmaceutical company seeking an Associate Data Manager in their Clinical Data Sciences group. The role involves managing clinical data through review and query management, ensuring data integrity, and collaborating with team members to uphold operational excellence in data management.
Participate in CDS 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 CDS 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 CDS 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
Qualification
Required
Bachelor's degree minimum requirement
0 - 2 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)
Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.)
Preferred
Health Sciences experience or Technology degree preferred
Awareness of MedDRA/WHO-Drug preferred
Benefit
Participation in Pfizer’s Global Performance Plan with a bonus target of 7.5% of the base salary
401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution
Paid vacation, holiday and personal days
Paid caregiver/parental and medical leave
Health benefits to include medical, prescription drug, dental and vision coverage
Relocation assistance may be available based on business needs and/or eligibility
Pfizer is a biopharmaceutical company that discovers, develops, and delivers medicines and vaccines.
