Summit Therapeutics, Inc.
Senior Manager, Centralized & Risk-Based Monitoring
Summit Therapeutics, Inc., Menlo Park, California, United States, 94029
Senior Manager, Centralized & Risk-Based Monitoring
Location: On‑site, 4 days per week at our Menlo Park, CA; Princeton, NJ or Miami, FL locations.
About Summit Therapeutics, Inc.
Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. Our core values include integrity, passion for excellence, purposeful urgency, collaboration, and a commitment to people.
Overview We are seeking a meticulous and detail‑oriented Senior Manager, Centralized & Risk‑Based Monitoring to oversee the quality and integrity of clinical trial data, perform remote centralized monitoring, and ensure compliance with regulatory requirements. This role will identify, assess, and mitigate risks, ensure optimal site performance, and collaborate with cross‑functional teams to improve clinical trial execution. The position also entails identifying trends or discrepancies and collaborating with sites to support data cleaning, risk‑based monitoring, and overall success of the clinical trial process.
Key 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.
Collaborate with clinical research associates, 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 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 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.
Qualifications
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.
Minimum of 8+ years of clinical research / clinical trial management experience in a 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, GCP, and regulatory guidelines.
Excellent analytical and problem‑solving skills, with the ability to identify trends and issues in clinical data.
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.
Compensation Pay range: $158,000 – $185,000 annually. Additional compensation may include bonus, stock, benefits, and other variable compensation.
Contact Interested candidates should apply through our career portal or contact Summit’s Talent Acquisition team at recruiting@smmttx.com for prior written authorization before referring any candidates.
#J-18808-Ljbffr
About Summit Therapeutics, Inc.
Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. Our core values include integrity, passion for excellence, purposeful urgency, collaboration, and a commitment to people.
Overview We are seeking a meticulous and detail‑oriented Senior Manager, Centralized & Risk‑Based Monitoring to oversee the quality and integrity of clinical trial data, perform remote centralized monitoring, and ensure compliance with regulatory requirements. This role will identify, assess, and mitigate risks, ensure optimal site performance, and collaborate with cross‑functional teams to improve clinical trial execution. The position also entails identifying trends or discrepancies and collaborating with sites to support data cleaning, risk‑based monitoring, and overall success of the clinical trial process.
Key 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.
Collaborate with clinical research associates, 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 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 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.
Qualifications
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.
Minimum of 8+ years of clinical research / clinical trial management experience in a 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, GCP, and regulatory guidelines.
Excellent analytical and problem‑solving skills, with the ability to identify trends and issues in clinical data.
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.
Compensation Pay range: $158,000 – $185,000 annually. Additional compensation may include bonus, stock, benefits, and other variable compensation.
Contact Interested candidates should apply through our career portal or contact Summit’s Talent Acquisition team at recruiting@smmttx.com for prior written authorization before referring any candidates.
#J-18808-Ljbffr