Operational Compliance Manager

Role Overview

• Oversee the accuracy and quality of data for research projects within a designated research site.
• Develop, maintain and produce dashboard metrics for site recruitment, participant statuses and operational quality metrics for research projects within a designated research site.
• Oversee the Data and Quality Processes within a designated site, which include PI Oversight, Delegation Log checks, and SAE reporting tracking.
• Oversee the implementation of best practices within a designated site to pre-empt quality issues.
• Collaborate with the Operational Compliance Team with the management of quality issues reported in the Care Access Quality Management System specific to a designated site.
• Collaborate with the Operational Compliance Team for the facilitation and participation of Root Cause Analysis.
• Complete operational compliance checks on clinical trial records for a designated site ensuring that source data, CRF and ISF records are accurate complete and inspection ready at all times.
• Ensure designated site staff are compliant with regulatory, client and or Sponsor requirements and or expectations
• Ensure site-level compliance with local regulations, including maintenance of ethics and regulatory documentation aligned with Brazilian requirements.
• Monitor adherence to LGPD (Lei Geral de Proteção de Dados) requirements in clinical research operations, including participant data handling and documentation practices.
• Proactively identify operational and compliance risks specific to Brazilian site operations and escalate trends to the Global Operational Compliance team.
• Lead or support localized Corrective and Preventive Action (CAPA) development and follow-up for site-level deviations and audit findings.
• Support inspection readiness activities tailored to Brazil, including mock inspections and documentation reviews reflecting local regulatory expectations.
• Support site with monitoring follow up letters
• Review and report on trends and issues
• Act as a key liaison between site teams, Global Operational Compliance, and regional leadership to ensure consistent implementation of Care Access quality standards within Brazil.
• Collaborate with Study Operations, Corporate support teams and Investigator teams to align operational practices with both global SOPs and Brazilian regulatory frameworks.
• Provide input into the adaptation of global SOPs and quality tools to ensure operational feasibility within the Brazilian clinical research environment.
• Support onboarding and continuous training of site staff on GCP, Brazilian regulations, and Care Access operational quality standards.
• Reinforce a culture of quality and inspection readiness through routine coaching, spot checks, and on-the-job guidance.
• Contribute to regional quality and performance reporting, identifying Brazil-specific trends related to data quality, protocol deviations, and inspection findings.
• Support continuous improvement initiatives by using operational metrics to recommend process enhancements at the site level.

Requirements

• Expert working knowledge of GCP guidelines and quality regulations/expectations pertaining to clinical trials.
• Knowledge and understanding of the industry requirements, best practice, and organization of a clinical research site.
• Minimum of 3 years industry experience and have had exposure to internal audits as well as Regulatory inspections.

Tech Stack

• Google Cloud Platform

Benefits

• Paid Time Off (PTO) and Company Paid Holidays
• Medical, dental, and vision insurance plan options