Senior Manager, Centralized & Risk-Based Monitoring

Summit Therapeutics Sub-posted 7 days ago
$158,000 - $185,000/Yr
Full-time • Mid Level
Onsite • Menlo Park, CA
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We are seeking a meticulous and detail-oriented Senior Manager, Centralized & Risk Based Monitoring to join our team. This is a critical role in overseeing the quality and integrity of clinical trial data, performing remote centralized monitoring, and ensuring compliance with regulatory requirements.?This role will be responsible for identifying, assessing, and mitigating risks, ensuring optimal site performance, and collaborating with cross-functional teams to improve clinical trial execution.?This position also involves identifying trends or discrepancies and collaborating with sites to support data cleaning, risk-based monitoring, and the overall success of the clinical trial process.

  • Central Monitoring: Lead the implementation of centralized monitoring strategies across multiple clinical trials
  • Monitor and review clinical trial data across sites to ensure accuracy, completeness, and consistency with study protocols.
  • Perform real-time data surveillance to identify outliers, trends, and potential issues that could impact data integrity.
  • Conduct risk-based monitoring activities, such as assessing site performance, patient safety data, and identifying sites at risk of data discrepancies or protocol violations.
  • Utilize central monitoring tools and platforms (e.g., EDC, CTMS) to track study progress and ensure data consistency.
  • Support data query resolution by coordinating with site and CRO teams and ensuring timely data corrections.
  • Clinical Data Review: Review clinical data for trends, outliers, and inconsistencies that could indicate data issues or non-compliance with the protocol.
  • Conduct data reviews in line with study timelines and regulatory requirements.
  • Evaluate subject data for completeness and accuracy to identify discrepancies early in the trial.
  • Collaborate with clinical research associates (CRAs), data managers, medical team, and other stakeholders to ensure corrective actions are taken as needed.
  • Provide feedback and report findings to the study team and support the preparation of data review reports for internal and regulatory audits.
  • Collaboration and Communication: Communicate effectively with study teams (e.g., CRAs, data managers, medical monitor, project managers) to ensure continuous support for site performance and data quality.
  • Act as a central point of contact for data queries and assist in resolving issues in a timely manner.
  • Work closely with clinical operations teams to provide proactive data quality oversight and identify potential risks in the clinical trial process.
  • Communicate directly with study sites when necessary to resolve data issues.
  • Reporting and Documentation: Maintain detailed records of data reviews, monitoring activities, and corrective actions taken to ensure audit readiness.
  • Prepare monitoring reports summarizing findings, trends, and recommendations for improvements.
  • Contribute to the preparation of clinical trial data for regulatory submission, ensuring adherence to required standards.
  • Regulatory Compliance and Quality Assurance: Ensure compliance with Good Clinical Practice (GCP), ICH guidelines, FDA regulations, and other relevant regulatory requirements.
  • Assist in preparation for external audits, inspections, and quality control checks.
  • Participate in internal quality assurance activities and continuous improvement initiatives.
  • Travel occasionally to sites to conduct monitoring visits when needed.
  • This is primarily an in-house role.
  • All other duties as assigned
  • Bachelors degree in Life Sciences, Clinical Research, Nursing, or related field strongly preferred; certification in Clinical Research (e.g., CCRP, CCRA) or related field is a plus.
  • A minimum of 8+ years of clinical research / clinical trial management experience in conducting clinical trials in Pharma/Biotech organization
  • Proven experience in centralized monitoring or clinical data review, with at least 5+ years in clinical trial monitoring (CRA roles)
  • Strong oncology trial monitoring experience (phases 2 and 3)
  • Familiarity with clinical data management systems (e.g., EDC, CTMS) and remote monitoring tools
  • Strong understanding of clinical trial processes, Good Clinical Practice (GCP), and regulatory guidelines
  • Excellent analytical and problem-solving skills, with the ability to identify trends and issues in clinical data
  • Strong attention to detail, organizational skills, and ability to manage multiple tasks simultaneously
  • Effective communication skills and ability to work collaboratively with cross-functional teams
  • Tenacity to work in a fast-paced team environment
  • Experience with risk-based monitoring approaches is a plus
  • Experience with statistical analysis software or data review tools
  • Knowledge of clinical trial data review processes and data cleaning methodologies
  • Certification in Clinical Research (e.g., CCRP, CCRA) or related field is a plus.
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