Clinical Research Leader, Neurovascular Resume

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Clinical Research Leader, Neurovascular Resume Jameson Zimmerman Clinical Research Leader, Neurovascular (919) 555-2846 jameson.zimmerman@example.com linkedin.com/example/jamesonzimmerman Durham, NC 27701 STRENGTHS Participant safety Safety reviews brought clinical, quality, regulatory, and site voices together before decisions moved forward. Global trial leadership When country needs differed, aligned plans kept investigators focused and gave teams confidence in delivery. Evidence writing Clear protocols and reports helped reviewers reach decisions faster, with fewer rounds of clarification. Cross functional trust Colleagues sought practical guidance on difficult site issues, especially when timelines and evidence needs collided. Independent judgment Careful issue framing supported timely choices, and study teams knew when escalation carried real value. SKILLS Clinical research science Medical devices ICH GCP ISO 14155 MDR MEDDEV Trial management Evidence generation ClinicalTrials.gov Safety management Adverse event reporting Clinical data management Regulatory affairs Technical writing Project budgets LANGUAGES English Native 40 Spanish Intermediate 20 MY CAREER 8.8 Years Clinical Research Leader, Neurovascular Trials at Cerevia Medical Devices (3.5 Years) Senior Clinical Research Manager, Device Studies at Arcstone Neurotech (2.2 Years) Clinical Research Manager, Vascular Devices at Blue Ridge Vascular Innovations (2.4 Years) Clinical Research Associate, Medical Devices at Piedmont Clinical Research Collaborative (8 Months) SUMMARY Clinical Research Leader with nine years of medical device and neurovascular trial experience across global study execution, evidence generation , clinical safety, and product development. Leads trials from feasibility and site selection through monitoring, closeout, data review, registration, publication support, and post market follow up. Authors protocols, informed consents , CRFs, monitoring plans , study manuals, investigator brochure content, annual reports, and safety plans. Partners with investigators, CRAs, sites, IRBs and ECs, vendors, Regulatory Affairs, Medical Affairs, R&D, data management, and biostatistics. Applies ICH GCP, ISO 14155, MDR, MEDDEV, SOPs, and global regulations while protecting participants, controlling budgets, and meeting milestones. Brings practical judgment, clear technical writing, and steady cross functional leadership that supports safe evidence generation and sound clinical decisions. EXPERIENCE Clinical Research Leader, Neurovascular Trials Cerevia Medical Devices April 2023 - Present Durham, NC Leads two multinational neurovascular device trials from feasibility through closeout, directing study resources, evidence plans, safety coordination, and cross functional delivery within approved budgets and regulatory commitments. Led two multinational neurovascular trials through feasibility, execution, closeout, budgets, and regulatory milestones. Authored protocols, consent forms, CRFs, monitoring plans, manuals, brochures, and annual reports . Resolved site, enrollment, data quality, and device accountability issues through risk based oversight. Directed clinical data review with data management and biostatistics before analyses and publications. Maintained ClinicalTrials.gov records while coordinating evidence input for product development and life cycle planning. Coordinated safety plans, adverse event reviews, authority reporting, ethics reporting, and adjudication activities. Senior Clinical Research Manager, Device Studies Arcstone Neurotech January 2021 - March 2023 Charlotte, NC Managed pivotal and post market interventional neurology studies, aligning sites, vendors, monitoring plans, budgets, evidence packages, and clinical resources across concurrent projects. Managed pivotal and post market device studies using country, site, vendor, and monitoring plans. Controlled investigator agreements , site payments, vendor scopes, inventories, budgets, and milestone recovery actions. Led qualification, initiation, interim, and closeout visits under ICH GCP, ISO 14155 , and SOPs. Developed PMCF Plan content and Evaluation Report summaries using literature, complaint, and study evidence. Supported regulatory and notified body discussions with safety findings and benefit risk evidence packages. Mentored clinical staff on monitoring quality, site communication, technical writing , and project escalation. Clinical Research Manager, Vascular Devices Blue Ridge Vascular Innovations July 2018 - December 2020 Greensboro, NC Managed vascular device operations and evidence activities, connecting investigators, IRBs, CRO staff, engineers, and medical stakeholders with study timelines and product review needs. Managed vascular device operations with investigators , IRBs , CRO staff, engineers, and medical stakeholders. Built feasibility assessments around investigator capability, patient populations, procedures, and operational readiness. Maintained registrations, essential documents, safety correspondence, monitoring files, and device accountability records. Reviewed data listings and source queries with CRAs and data management before analysis milestones. Prepared literature assessments and evidence summaries for clinical evaluations , presentations, and product reviews. Tracked budgets , vendor deliverables, and timelines, then proposed recovery actions for emerging constraints. Clinical Research Associate, Medical Devices Piedmont Clinical Research Collaborative October 2017 - June 2018 Winston Salem, NC Monitored medical device and surgical research sites, supporting compliant execution, participant protection, source review, safety escalation, device accountability, and investigator communication. Monitored medical device sites , verifying consent, source records, eligibility, adherence, and essential files. Conducted qualification, initiation, interim, and closeout visits with documented findings and follow up. Reviewed adverse event documentation and routed safety information according to approved study procedures. Reconciled device receipt, use, return, and disposition records against site documentation. Supported investigators with CRFs , query resolution, manual interpretation, and audit preparation. Managed visit schedules, reports, and follow up while maintaining trusted site relationships. PROJECTS Global Neurovascular Evidence Program 2024 Coordinated clinical, safety, regulatory, and data partners around a global evidence plan for neurovascular devices. Clear ownership helped teams resolve open questions and keep decisions grounded in participant safety and clinical evidence. Post Market Clinical Follow Up Framework 2022 Connected literature review, complaint information, clinical findings, and regulatory input into PMCF planning. Cross functional review gave colleagues a shared view of evidence gaps and practical next steps. LEADERSHIP & AWARDS Clinical Research Leadership Recognition, Cerevia Medical Devices, 2025 Clinical Operations Excellence Award, Arcstone Neurotech, 2022 Study Team Mentor Recognition, Arcstone Neurotech, 2021 EDUCATION Master of Science in Clinical Research Duke University GPA: 4.0 2017 Durham, NC Coursework: Clinical trial design, biostatistics, clinical data management, regulatory affairs Bachelor of Science in Biological Sciences North Carolina State University GPA: 4.0 2015 Raleigh, NC Coursework: Human biology, physiology, research methods, biological statistics CERTIFICATIONS Certified Clinical Research Professional 2019 Good Clinical Practice Training 2026 TECHNICAL SKILLS Clinical Trial Operations: Feasibility, site selection, monitoring Clinical Documents: Protocols, informed consents, CRFs Study Oversight: Study manuals, monitoring plans, annual reports Medical Device Standards: ISO 14155, MDR, MEDDEV Good Clinical Practice: ICH GCP, SOPs, global regulations Safety Management: Safety plans, adverse events, adjudication Clinical Data Systems: ClinicalTrials.gov, data review, data listings Post Market Evidence: PMCF Plans, PMCF Evaluation Reports, literature assessment Regulatory Submissions: Regulatory affairs, notified body discussions, authority reporting Project Controls: Budgets, milestones, vendor scopes Stakeholder Platforms: IRBs, ECs, investigator sites Product Development: New Product Development, Life Cycle Management, benefit risk SKILLS Clinical research science Medical devices ICH GCP ISO 14155 MDR MEDDEV Trial management Evidence generation ClinicalTrials.gov Safety management Adverse event reporting Clinical data management Regulatory affairs Technical writing Project budgets PROFESSIONAL AFFILIATIONS Association of Clinical Research Professionals, member since 2019 Regulatory Affairs Professionals Society, clinical research participant Medical Device Clinical Research Network, professional member LANGUAGES English (Native) Spanish (Intermediate) ADDITIONAL INFORMATION Work Status : Authorized to work in United States. No sponsorship required. ADDITIONAL INFORMATION Work Status : Authorized to work in United States. No sponsorship required. REFERENCES AVAILABLE ON REQUEST

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