Summit Therapeutics, Inc. · 2 weeks ago
Senior Manager, Centralized & Risk-Based Monitoring
Menlo Park, CA
Full-time
Onsite
Senior Level, Lead/Staff
$158K/yr - $185K/yr
8+ years expSummit Therapeutics Inc. is a biopharmaceutical oncology company focused on improving quality of life through innovative clinical studies. They are seeking a Senior Manager for Centralized & Risk-Based Monitoring to oversee the quality of clinical trial data, ensure compliance with regulations, and collaborate with cross-functional teams to enhance clinical trial execution.
BiotechnologyHealth CareMedical DeviceTherapeutics
Responsibilities
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
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
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
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
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
Qualification
Required
Bachelor's 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
Preferred
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
Benefits
Bonus
Stock
Benefits
Other applicable variable compensation
Company
Summit Therapeutics, Inc.
Summit Mission Statement: To build a viable, long-lasting health care organization that assumes full responsibility for designing, developing, trial execution and enrollment, regulatory submission and approval, as well as successful commercialization of patient, physician, caregiver, and societal-friendly medicinal therapy intended to: improve quality of life, increase potential duration of life, and resolve serious medical healthcare needs.
201-500 employees
H1B Sponsorship
Summit Therapeutics, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (6)
2023 (1)
Funding
Current Stage
Public CompanyTotal Funding
$1.79BKey Investors
CARB-XEurofarmaBiomedical Advanced Research and Development Authority (BARDA)
2025-10-21Post Ipo Equity· $500M
2024-09-11Post Ipo Equity· $235M
2024-06-03Post Ipo Equity· $200M
Leadership Team
Manmeet Soni
Chief Operating Officer and Chief Financial Officer
Recent News
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