Senior Associate, Central Monitor, Data Surveillance

About the role

Pfizer is hiring a Senior Associate, Central Monitor for its Clinical Data Sciences function in Buenos Aires, Argentina (Complejo LUMINA office park). The role follows a hybrid model, with colleagues expected to work from the assigned Pfizer office 2-3 days per week or as required by business needs. The Senior Associate ensures the completeness, quality and integrity of subject data in the clinical trial database under Risk Based Monitoring (RBM) mode, and may act as CM Program Oversight Lead.

Key responsibilities

• Implement global strategies, processes and standards so that study processes are consistent, efficient and meet quality, timeline and deliverable goals.
• Set up and test study-level RBM systems, define Key Risk Indicators (KRIs) and data quality assessment dictionaries, and ensure alignment with protocols, ICH GCP, SOPs and regulatory requirements.
• Review system outputs and propose signals and actions, then follow up with the study team until issues are resolved.
• Work with the global study team and the Clinical Data Scientist to mitigate signals and actions and release RBM systems.
• Document lessons learned and share them across studies, and plan communications to keep customers satisfied.
• Provide technical oversight and quality control steps for central monitor activities.

Required profile

• Bachelor's degree or above, or equivalent experience, in a scientific or business-related discipline.
• 3-5 years of experience in clinical development.
• Working knowledge of the clinical development process, Phase I-IV concepts and study design principles.
• Previous data management experience, including CRF design, database set-up, edit checks, DMPs and data cleaning.
• Project management skills, strong communication with internal and external stakeholders, and ability to work independently.

Required skills

• Clinical trial database knowledge and Windows environment tools (Word, Excel, PowerPoint, Project).
• Oracle, PL/SQL, SAS, Java, relational database design and database programming.
• Technical expertise in clinical trial database development, data management and site monitoring.