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, Global 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 interim/final report preparation and literature review abstraction and summarization
Coordinates the review and finalization of all vendor documents, such as the safety management, data management, communication, project management, and validation plans
Tracks study timelines and deliverables and follows up on action items
Collaborates extensively and troubleshoots issues by providing potential resolutions (when necessary) with internal and external partners, ensuring timely study management and execution
Assists in tracking study milestones and timelines
Liaises with outsourced vendors and cross-functional teams to communicate and oversee project status and/or needs
Participates in quality control assessments and ensures integrity of study data for reports and publications
Understands, coordinates, and documents adherence to internal, external, and regulatory compliance requirements
Utilizes, manages, and maintains document repositories and internal/external systems (e.g., REV OPs, External TEAMS, Veeva Vault)
Provides operational support for due diligence checks, site contract and budget review/approval, informed consent, study registration, IT and/or privacy assessments, vendor qualification, adverse event reporting and reconciliation, and publication submissions
Manages poster and publication development, including formatting, medical writing, figure/data content development, co- author review, internal review process
Minimum FTE Years of Experience
Two or more years of work experience within clinical/observational research or equivalent experience
Oncology experience is required
Excellent communication and interpersonal skills and the ability to collaborate with and influence a wide variety of stakeholders
Basic knowledge of epidemiologic or outcomes research
Fluency in English (written and spoken)
Strong project management and prioritization skills
High level of motivation and ability to work independently and collaboratively
Educational Requirement
Bachelor’s degree in public health or science discipline
Master’s degree in public health (or closely related discipline, such as health administration or biological sciences) preferred;
Project Management Professional or Certified Associate Project Management certification preferred.
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