Senior Clinical Trial Manager Resume

Candidate Pitch:

Analytical, performance-focused, and forward-thinking professional, with extensive experience in all phases of clinical trials, from initiation to close-out, while leading global study teams and working with external vendors. Known for effectiveness in overseeing clinical trials across multiple therapeutic areas such as cell therapy, oncology, autoimmune, ophthalmology, respiratory, and neurology. Capable of providing administrative oversight to study management teams, ensuring timely collection and submission of documentation and local R&D review and approval. Equipped with solid expertise in conducting feasibility assessments and leveraging knowledge of regulatory compliance and ICH-GCP guidelines to ensure clinical trials are conducted with the highest levels of quality and integrity. IMMPACT BIO | WEST HILLS, CA, USA Senior Clinical Trials Manager 07/2024–01/2025  Solely lead the phase I CAR-T clinical trial for lymphoma, from study start-up, feasibility, and site selection to patient enrollment and trial execution, ensuring adherence to ICH/GCP guidelines and standard operating procedures (SOPs).  Supervise a cross-functional team in clinical trial milestones attainment, quality control, budget compliance, and efficient operations including chairing internal and external study team meetings  Review local ethics submissions and regulatory greenlight packages.  Work with clinical research organizations (CROs) to evaluate, select, and oversee clinical trial sites, ensuring protocol adherence and site readiness.  Develop and refine internal and external study-specific plans, timelines, and essential documents, including protocols, informed consent forms, and project plans.  Manage study budgets, review invoices, and coordinate financial planning with Finance and Clinical Development teams.  Continuously train investigators, site staff, and internal teams to drive protocol compliance and operational efficiency.  Guide vendor and CRO performance, ensuring compliance with trial requirements and mitigating risks proactively including reviewing monitoring visit reports and protocol deviations.  Conduct ongoing data reviews, provide study updates to senior leadership, and participate in request for proposal (RFP) and vendor selection processes.  Instruct and supervise new clinical trial personnel, fostering professional development while contributing to SOP development, enhancements and best practices.  Strengthened relationships with study sites and vendors, optimizing patient enrollment strategies and enhancing site monitoring quality. KITE PHARMA | VARIOUS LOCATIONS Senior Clinical Trial Manager Associate | SANTA MONICA, CA, USA 06/2022–02/2024 Senior Clinical Trial Management Associate | LONDON, ENGLAND, UK 08/2021–06/2022 Clinical Trials Management Associate | LONDON, ENGLAND, UK 05/2020–08/2021  Managed regulatory submissions and site approvals across EMEA and APAC, ensuring adherence to regional requirements and expediting implementation in alignment with global study objectives.  Authored and updated study documentation, including protocols, informed consent forms (ICFs), study monitoring plans, and regulatory submission materials, ensuring alignment with industry best practices.  Headed site monitoring activities and sponsor-oversight visits to review interim monitoring visit (IMV) reports, ensure adherence to study protocols, and proactively address compliance gaps.  Administered inspection readiness initiatives, contributing to investigational product reconciliation, TMF quality control, and participation in mock audits and regulatory inspections with the FDA, Pharmaceuticals and Medical Devices Agency (PMDA), and other agencies.  Rendered mentorship and leadership development for junior team members through structured one-on-one sessions, regional team meetings, and an onboarding "buddy" program.  Co-managed the Clinical Trial Management Associates (CTMA) Forum, organizing quarterly knowledge-sharing sessions, facilitating cross-functional collaboration, and driving continuous learning initiatives across clinical trial management teams.  Rendered end-to-end oversight for a pivotal phase 3 oncology trial across North America, Europe, and Asia Pacific (APAC), acting as the primary escalation point to foster strong collaborations with CROs, vendors, and study sites.  Successfully led the global phase 3 study, bringing second-line treatment to market that achieved full Food and Drug Administration (FDA), Europe, the Middle East and Africa (EMEA), Medicines and Healthcare products Regulatory Agency (MHRA), and Pharmaceuticals and Medical Devices Agency (PDMA) approvals.  Spearheaded study execution and timeline management, ensuring seamless coordination between regional teams, delegating key responsibilities, and mitigating potential delays.  Drove global data review and cleaning efforts, overseeing team assignments, maintaining real-time trackers, and facilitating weekly data reconciliation meetings to ensure data accuracy and compliance. PPD | CAMBRIDGE, ENGLAND, UK Senior Clinical Research Associate (CRA) 10/2017–05/2020  Acted as the primary liaison for investigative sites including both blinded and unblinded, ensuring seamless communication and trial execution.  Safeguarded patient rights, safety, and well-being, while upholding the scientific integrity of study data.  Carried out site selection, feasibility assessments, initiation, routine monitoring, and close-out visits in order to maintain protocol adherence.  Oversaw complex studies and high-risk sites, ensuring data accuracy, protocol adherence, and resolution of monitoring challenges.  Educated junior CRAs, supporting their development in study monitoring and regulatory adherence.  Dealt site contracts in alignment with National Institute for Health and Care Research (NIHR) guidelines.  Coordinated study supply logistics, guaranteeing accurate delivery of clinical systems and study materials across sites. QUINTILESIMS | READING, ENGLAND, UK Clinical Research Associate 08/2015–10/2017  Arranged on-site and remote monitoring activities, including site initiations, observation, and close-outs for a one-sponsor team.  Handled the site set-up, including document collection, liaising with NHS and private physicians (PI, Sub-I), and coordinating with research teams such as data management, pharmacy, and imaging to activate sites.  Collaborated with sites to develop and track subject recruitment plans, aligning with project needs to improve predictability.  Executed source data verification, compliance checks, eligibility reviews, informed consent assessments, finance/invoicing, eTMF filing, and drug accountability according to SOPs.  Developed and kept comprehensive documentation of site management, monitoring visit findings, and action plans, and submitted regular visit reports and follow-up letters.  Tracked study progress by monitoring regulatory submissions, approvals, recruitment, enrolment, CRF completion, data query generation, resolution, and database lock. SARAH CANNON RESEARCH INSTITUTE | LONDON, ENGLAND, UK Clinical Trial Coordinator 10/2014–08/2015  Accomplished essential trial documentation from set-up to close-out with minimal supervision.  Prepared and submitted amendments to R&D, IEC, and ARSAC.  Organized and facilitated sponsor-initiated pre-selection and site initiation visits.  Delivered SUSAR reports to the research team and tracked the review process.  Addressed queries with investigators and CRAs for assigned studies.  Ensured adherence to and implementation of SOPs.  Maintained the Investigator Site File for over 25 studies. EARLIER CAREER OTG-I | LONDON, ENGLAND, UK Clinical Research Assistant 6 months EDITH COWAN UNIVERSITY | JOONDALUP WA 6027, AUSTRALIA Clinical Trials Coordinator 6 months Master of Business Administration, In Progress (Expected Completion: 2027) Golden Gate University • San Francisco, CA, USA Bachelor of Science in Health Administration, 11/2010 Eastern Michigan University • Ypsilanti, MI, USA Clinical Strategy Development | Clinical Protocol Development | Good Clinical Practice Integration | Site Selection IRB/IEC Submission and Approval | Vendor Management | Trial Master File (TMF) Maintenance | Quality Control Clinical Risk-Based Monitoring | Global Trial Coordination | Cost Control