Senior Manager, Centralized & Risk-Based Monitoring at Summit Therapeutics Sub

Location: On-Site 4 days per week at our Menlo Park CA Princeton NJ or Miami FL locationsAbout Summit:Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life increasing potential duration of life and resolving serious unmet medical needs. At Summit we believe in building a team of world class professionals who are passionate about this mission and it is our people who drive this mission to reality. Summits core values include integrity passion for excellence purposeful urgency collaboration and our commitment to people. Our employees are truly the heart and soul of our culture and they are invaluable in shaping our journey toward excellence.Summits team is inspired to touch and help change lives through Summits clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies including:Non-small Cell Lung Cancer (NSCLC)HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC.Colorectal Cancer (CRC)HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than Chinas National Medical Products Administration (NMPA). Summit is headquartered in Miami Florida and has additional offices in California New Jersey the UK and Ireland.OverviewWe 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 role will be responsible for identifying assessing and mitigating risks ensuring optimal site performance and collaborating with cross-functional teams to improve clinical trial 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.Key Responsibilities:Central Monitoring:Lead the implementation of centralized monitoring strategies across multiple clinical trialsMonitor 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 assignedQualifications: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 organizationProven 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 toolsStrong understanding of clinical trial processes Good Clinical Practice (GCP) and regulatory guidelinesExcellent analytical and problem-solving skills with the ability to identify trends and issues in clinical dataStrong attention to detail organizational skills and ability to manage multiple tasks simultaneouslyEffective communication skills and ability to work collaboratively with cross-functional teamsTenacity to work in a fast-paced team environmentExperience with risk-based monitoring approaches is a plusExperience with statistical analysis software or data review toolsKnowledge of clinical trial data review processes and data cleaning methodologiesCertification in Clinical Research (e.g. CCRP CCRA) or related field is a plus.The pay range for this role is $158000-$185000 annually. Actual compensation packages are based on several factors that are unique to each candidate including but not limited to skill set depth of experience certifications and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus stock benefits and/or other applicable variable compensation.Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summits Talent Acquisition team atto obtain prior written authorization before referring any candidates to Summit.Required Experience:Senior Manager Key Skills Arm,Risk Management,Financial Services,Cybersecurity,COSO,PCI,Root cause Analysis,COBIT,NIST Standards,SOX,Information Security,RMF Employment Type : Full-Time Experience: years Vacancy: 1 Yearly Salary Salary: 158000 - 185000