17 ago
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Parexel
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México
Parexel FSP is hiring a Non-Interventional Study Research Manager to join our growing team in Brazil or Mexico
Job Overview
Under the supervision of an Associate Director, the Non-Interventional Study Research Manager leads operational activities supporting the planning, execution, and results summarization of observational and non-interventional research studies. The role coordinates compliance with Good Pharmacoepidemiology Practice (GPP) and applicable SOPs, and collaborates with colleagues across Global Medical and Scientific Affairs (GMSA) to support study conduct. Key responsibilities include vendor oversight, timeline tracking, quality control, publication development, and adherence to regulatory compliance requirements.
Description of Roles and Responsibilities
- Under the supervision of an Associate Director, leads operational activities related to study planning, study execution, and the summarization of results from observational research studies and related activities.
- Coordinates the end-to-end process for executing observational or non-interventional research studies, in compliance with Good Pharmacoepidemiology Practice (GPP) and V&I; OR Standard Operating Procedures (SOPs)
- Plans, initiates, executes, and closes out primary data collection, chart review, database, and molecular epidemiology studies in addition to other activities (e.g., literature reviews, dossier development, economic modelling support, etc.)
- Collaborates with colleagues across V&I; OR, General Medical and Scientific Affairs (GMSA) to support the lead scientists (from GMSA) in overall operational support for study conduct
- Provides study-level management support, which includes facilitation of the execution of appropriate service for approved proposals/scopes of work (including the review of requests for information/proposal, draft scope of work, where applicable), confidentiality and consultant agreements, and subsequent amendments/change orders
- Participates in protocol and
📌 Non-Interventional Study Research Manager (México)
🏢 Parexel
📍 México