Non-Interventional Study Research Manager - FSP

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

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.