Shannon Doppelheuer
Snellville
Summary
Experienced Senior Clinical Program Manager skilled in clinical trial management and cross-functional collaboration. Expertise in budget administration and regulatory compliance ensures successful project outcomes. Developed research protocols and fostered team engagement to enhance operational efficiency and quality in clinical programs.
Overview
16
16
years of professional experience
Work History
Senior Clinical Program Manager
Vastrax, Inc.
Waltham
03.2022 - Current
- Manages cross functional project teams derived from the groups within clinical development to deliver a high-quality clinical trial(s) in compliance with all regulations and SOPs
- Works with functional areas on initiating, planning, executing, controlling, closing, and resourcing clinical trial projects
- Managed clinical project team including project managers, assistant project managers, clinical trial associates, and supporting staff to ensure successful project execution.
- Acts as an operational nexus or focal point for interdepartmental and intradepartmental groups (e.g., stats, data management, safety, manufacturing, regulatory, vendors), coordinating these different groups in a matrix environment to drive and complete clinical programs
- Collaborates with trial sponsors on the development of research protocols
- Developed comprehensive project plans and facilitated weekly budget and progress reviews, clarifying roles and responsibilities for each study.
- Developed project timelines for each project, tracking and managing progress effectively.
- Manage and coordinate all vendors involved in the clinical trials (e.g., central labs, IVRS/IWRS, core laboratory)
- Review study metrics for performance and quality with the team and management
- Reviews protocol, source documents and CRFs and tracks them to completion
- Assisted in preparing new study budgets and proposal documents, while also participating in bid defenses.
- Takes an active role in department and company-wide process improvement initiatives
- Represents Vastrax at professional meetings or seminars
ENDOLOW Project Manager | Manager, Program and Res
Emory University School of Medicine, Department o
Atlanta
04.2018 - 03.2022
- Manage the strategic planning process and oversee progress toward achieving project goals
- Develop and administer project budgets
- Develop short- and long-term project goals and objectives
- Directed special projects for non-central divisions, aligning initiatives with organizational objectives
- Represent and promote projects at speaking engagements and with various constituencies
- Analyze data and identify and summarize trends; identify data discrepancies and identify causes
- Developed and prepared reports assessing study performance and treatment results to inform decision-making
- Developed plans for program growth and served as liaison to committees and organizations, representing projects at meetings and events
- Contribute to the development of research protocols and determines how research methodologies or tools must be modified
- Ensure study data and systems are maintained and accurately documented
- Collaborate with representatives from private, government, and international agencies
- Represent the Emergency Medicine Research program in various national and international fora
Clinical Research Coordinator IV
Emory University School of Medicine
Atlanta
09.2015 - 12.2018
- Managed and maintained several complex research trials and multiple smaller clinical research projects, ensuring compliance and successful execution
- Supervise implantation and adherence to study protocols
- Reviewed and negotiated study budgets for new clinical trials and amendments, aligning financial resources with project goals
- Monitor departmental expenditures and budgets, including research staff salaries, benefits, and fringe
- Provide guidance in identifying and implementing corrective action plans
- Develop and maintain multiple clinical trial related information systems
- Recruit, orient and supervise research staff, some of whom with more than twenty years of service
- Installed new study-related software and equipment in collaboration with hospital, sponsor, and research staff.
Clinical Research Coordinator
Dekalb Neurology Associates, LLC / NeuroStudies.net, LLC
Decatur
06.2010 - 07.2012
- Reviewed and adhered to study protocol, prescreened, screened, and enrolled subjects to ensure compliance and participant safety.
- Communicated serious adverse events to IRB, CRO, and pharmaceutical company in accordance with FDA guidelines to ensure participant safety and regulatory compliance.
- Ensure proper written informed consent obtained prior to any procedures
- Created source documents and ancillary worksheets, maintained, and updated case report forms on electronic data capture (EDC) to support accurate data collection.
- Maintain and update regulatory documents for the IRB and Site File Notebook
- Dispense and track medications and maintain and update study drug accountability logs
- Collect patient data and obtain copies of hospital and office medical records
- Monitored vital signs, performed EKGs, and conducted phlebotomy for specimen collection and processing.
Education
Bachelor of Arts -
University of Georgia
Athens, GASkills
- Clinical trial management
- Research protocol development
- Regulatory compliance
- Budget administration
- Project planning
- Cross-functional collaboration
- Stakeholder engagement
Affiliations
- American Heart Association, 01/01/13, present
- Association of Clinical Research Professionals, 01/01/13, present
- Georgia Stroke Professional Alliance, 01/01/13, 01/01/22
- Georgia Stroke Professional Alliance Secretary, 01/01/19, 01/01/22
- Georgia Stroke Professional Alliance Treasurer, 09/01/13, 08/31/15
- Grady Comprehensive Stoke Center Certification Team Member, 01/01/13, 01/01/22
- Stroke Thrombectomy Endovascular Platform (STEP) Mild Deficit Working Group, 01/01/20, 01/01/22
Database Experience
E-Capture, iDATAFAX, iMedidata RAVE, iMednet, InForm, Oracle, REDCap, Cerner, EPIC, Ambra Health, BrainStorme, Globus, Oculus, Emory University Local IRB, Advarra cIRB, BRANY cIRB, WCG Connexus cIRB, WCG ClinSphere eReview Manager cIRB, Advarra, BSI, Complion, Florence, WEB DCU, Veeva Vault, Viedoc, MediaLab, NetSuite, QuickBase, QuickBooks
Clinical Research Trials
COMMAND – EFS: Implantable BCI to Control a Digital Device for People with Paralysis, ENVI-RCT – Envi-SR Randomized Controlled Trial for Endovascular Treatment of Ischemic Stroke, SEARCH – A Randomized Controlled Trial Comparing Surgiscopic Evacuation of Intracerebral Hemorrhage Versus Standard of Care Medical Management, TORNADO – Treatment of Ruptured Wide-Neck Aneurysms with Nautilus Device Assisted Occlusion, ATHENA – A PROSPECTIVE, RANDOMIZED, DUAL-ARM, MULTI-CENTER STUDY TO ASSESS THE SAFETY AND EFFECTIVENESS OF MECHANICAL THROMBECTOMY USING THE ANACONDA ANA5 DEVICE IN COMBINATION WITH A STENT RETRIEVER (ANA2401), DIRECT – Delay Avoiding Primary Evaluation for Thrombectomy for Acute Stroke Patients with Large Vessel Occlusion in the Angiography Suite (DIRECT) Trial, PIANO – p48/64 MW HPC in Aneurysm Occlusion (PCT-002-23), RP Pivotal – The Pivotal Study of RapidPulseTM Aspiration System as Frontline Approach for Patients with Acute Ischemic Stroke due to Large Vessel Occlusions, REACH - Rapid Evacuation and Access of Cerebral Hemorrhage (REACH) Trial, STRIDE – Pivotal Study to Evaluate the Safety and Effectiveness of the CereVasc eShunt System in the Treatment of Normal Pressure Hydrocephalus, BE-SILENT – Safety & Performance of the BosSTENT in the Treatment of Cerebral Venous Sinus Stenosis, ENDOLOW - Endovascular Therapy for Low NIHSS lschemic Strokes- (Clinical Project Manager), ESCAPE-NEXT - A Multicentre, Randomized, Double-blinded, Placebo-controlled, Parallel Group, Single-dose Design to Determine the Efficacy and Safety of Nerinetide in Participants with Acute Ischemic Stroke Undergoing Endovascular Thrombectomy Excluding Thrombolysis, SENSE-005 - A Prospective, Non-randomized, Sequentially-enrolled, Multi-center, Phase II Study to Evaluate the SENSE Device’s Ability to Detect and Monitor Traumatic Brain Injury, CLEAR – A protective, open-label, multi-center, single-arm trial design to assess the safety, performance and efficacy of the NeVaTM Stent Retriever in the treatment of large vessel occlusion strokes, ELEVATE – Evaluate Endovascular treatment of Acutely ruptured shallow intradural aneurysms with the PipelineTM Flex Embolization Device with Shield TechnologyTM, EMBOLISE – Embolization of the Middle Meningeal Artery with ONYXTM liquid Embolic System in the Treatment of Subacute and Chronic Subdural Hematoma, PROST – pREST for Occlusive Strome Treatment, STRIP - Thromboembolism Registry of Imaging and Pathology, SAHaRA - Aneurysmal Subarachnoid Hemorrhage - Red Blood Cell Transfusion and Outcome: A Randomized Controlled Trial, CBCT IIS - Image-guided Therapy for Stroke Intervention (co-investigator), C3PO - Clinical-trial of COVID-19 Convalescent Plasma in Outpatients, PACT - Prehospital Airways Control Trial, BOOST-3 - Brain Oxygen Optimization in Severe TBI, Phase 3, STEM - The SQUID Trial for the Embolization of the Middle Meningeal Artery for Treatment of Chronic Subdural Hematoma, Discovery of Biomarker Signatures Prognostic for Neuropathic Pain after Acute Spinal Cord Injury, A Study of the Pipeline Flex Embolization Device with Shield Technology for Endovascular Treatment of Wide-Necked Intracranial Aneurysms, Vitamin C, Thiamine, and Steroids in Sepsis, CHARM - A phase 11, double-blinded, randomized, placebo-controlled study to evaluate efficacy, safety and tolerability of BAF312 in patients with stroke due to intracerebral hemorrhage, SEPSIS-SHIELD - HostDx Sepsis in the Diagnosis and Prognosis of Emergency Department Patients with Suspected Infections, IMPERATIVE - A randomized, controlled, multi-center clinical investigation to evaluate and compare the safety and efficacy of using 2 QOM reperfusion catheters and stent retrievers in thrombectomy procedures to treat acute ischemic stroke patients, INSPIRE - Randomized, Controlled, Single-blind Study of Probable Benefit of the Neuro-Spina/ Scaffold for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury as Compared to Standard of Care, ICECAP - Influence of Cooling duration on Efficacy in Cardiac Arrest Patients, TED - The Traumatic Brain Injury: Friend Controls Study; leveraging the infrastructure of Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TB/): and funded by the TB/ Endpoints Development (TED) Initiative, Fibromuscular dysplasia in patients with acute ischemic stroke, TRACK-TBI - Transforming Research and Clinical Knowledge in Traumatic Brain Injury, ENRICH - Early Minimally-invasive Removal of ICH, ASTRAL - A Multicenter; Double-Blind, Multidose, Placebo-Controlled, Randomized, Parallel-Group, Phase 2 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 for Patients with Brain Contusion., Plasma and exosomal protein biomarker discovery for stroke, Association of Non-Contrast CT Imaging Characteristics of Clots in Acute Ischemic Stroke with Clinical and Procedural Outcomes, ALADIN: Automated Large Artery Occlusion Detection IN Stroke, Stroke/TIA Re-occurrence in Medically Managed Symptomatic Intracanal Stenosis Predictive Factors, and Response to Medical vs. Endovascular Therapy, Artificial Intelligence for Neuroimaging Parametric Analysis in Stroke, Evaluation of Long-Term Outcomes of Endovascular Therapy in Acute Stroke Patients, Neuroimaging Parametric Approaches - Retrospective characterization of neuroimaging parametric approaches in CNS disease, FAST-ED Scale Performance in a Mobile Stroke Unite, CoBIS2 - Phase 2 Study of Allogeneic Umbilical Cord Blood Infusion for Adults with Ischemic Stroke, ESCAPE-NA 1 - A Multicentre, Randomized, Double-blinded, Placebo-controlled, Parallel Group, Single dose Design to Determine the Efficacy and Safety of Intravenous NA-1 in Subjects with Acute Ischemic Stroke Undergoing Endovascular Thrombectomy, P-CARE Aim 3 - Patient-Centered Approaches to Research Enrollment Decisions in Acute Cardiovascular Disease- Intervention Phase, ARISE II - Analysis of Revascularization in Ischemic Stroke with EmboTrap, CoBIS - Allogeneic Umbilical Cord Blood Infusion for Adults with Ischemic Stroke, SAFETY AND EFFICACY OF ENDOVASCULAR TREATMENT WITHIN 6 HOURS IN NON-ELIGIBLE PATIENTS FOR INTRAVENOUS t-PA, CORDIS ENTERPRISE Vascular Reconstruction Device (VRD) and Delivery System (DS)-Humanitarian Device Exemption, DAWN - DWI or CTP Assessment with Clinical Mismatch in the Triage of Wake Up and Late Presenting Strokes Undergoing Neurointervention, Georgia StrokeNet Patient Registry, STRATIS Registry- Systematic Evaluation of Patients Treated with Neurothrombectomy Devices for Acute Ischemic Stroke Registry, TREVO Registry - Prospective, open-label, consecutive enrollment, multi-center; international registry to assess real world performance of the Trevo Retriever which is intended to restore blood flow in the neurovasculature by removing thrombus in subjects experiencing ischemic stroke., MiSPACE - Minimally invasive Subcortical Parafascicular Access for Clot Evacuation, Stroke Awareness and Perceived Risk Survey, NeuSTART - Neuroprotection with Stalin Therapy for Acute Recovery Trial Phase 2, Stroke Imaging Parameters - Retrospective Analysis of Imaging Findings and Clinical Impact in Acute Ischemic Stroke, Sulcal Effacement With Preserved Gray-White Junction: A Sign of Reversible Ischemia, Wingspan System Post Market Surveillance Humanitarian Device Exemption, Carotid artery elongation and the risk of dissection in acute ischemic stroke intervention, SWIFT PRIME - Solitaire FR with the Intention For Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke Clinical Trial, Aldagen ALD-401 - A Phase 2 Randomized, Controlled Study with a Phase 1 Safety Cohort testing ALD-401 Derived from Autologous Bone Marrow Delivered via Intracarotid Infusion in Subjects with Ischemic Stroke with Blinded Assessments., ReCCLAIM - Cooling after Endovascular Reperfusion in Ischemic Stroke Patients, PENUMBRA 3D - A randomized, concurrent controlled trial to assess the safety and effectiveness of the Separator 3D as a component of the Penumbra System in the revascularization of large vessel occlusion in acute ischemic stroke, DIAS 4 - A randomized, double-blind, parallel-group placebo-controlled phase III study to evaluate the efficacy and safety of desmoteplase in subjects with acute ischemic stroke, TREVO 2 - Thrombectomy Revascularization of large Vessel Occlusions in acute ischemic stroke, The THERAPY Trial: The Randomized, Concurrent Controlled Trial to Assess the Penumbra System's Safety and Effectiveness in the Treatment of Acute Stroke, CRISP - CT perfusion to predict Response to recanalization in Ischemic Stroke Project
Publications
- Body Mass Index and Clinical Outcomes in Large Vessel Occlusion Acute Ischemic Stroke after Endovascular Therapy: The Obesity Paradox
- Off-hour Presentation And Outcomes In Patients With Large Vessel Occlusion After Endovascular Therapy: A Matched Case-control Study
- The Smoking-Thrombolisis Paradox in Large Vessel Occlusion Acute Ischemic Stroke Undergoing Endovascular Therapy
- Beyond Large Vessel Occlusion Stroke: Distal Occlusion Thrombectomy
- Endovascular Therapy and Outcomes in Large Biracial Cohort Patients with Acute Ischemic Stroke
- Rate of “Non-Go Activation” of a High Volume Stroke Center Neuroendovascular Team during the “After-Hours”/On-Call Period: Exploring the Financial Impact to an Acute Stroke Program.
- “Double Trouble”: Endovascular Treatment of Tandem Arterial Occlusions in Acute Ischemic Stroke.
- The Georgia Stroke Professional Alliance (GA-SPA) – a Six Year Review of a Collaborate, Stat-wide Stroke Professional Network, Reaching Across State-lines and the Nation to Improve Stroke Care, Professional Education, and Community Outreach.
Education And Certifications
- National Institutes of Health IPPRC
- Certified Clinical Research Coordinator
- Modified Rankin Scale Certification
- Rankin Focused Scale Certification
- National Institute of Heath Stroke Scale Certification
- Certified Clinical Medical Assistant
- Certified Phlebotomy Technician
- Certified EKG Technician
- CITI Certification for Good Clinical Practices
- CITI Certification for Human Subjects Research
- IATA Certified for Shipping of Dangerous Goods
- American Heart Association BLS for Healthcare Provider (CPR & AED)
- Bachelor of Arts, University of Georgia
Presentations
- Clinical Trials Overview at the Marcus Stroke & Neuroscience Center, Grady Stroke Symposium, 09/01/13
- Clinical Trials: The Past, Present, and Future of Stroke Research, Grady Stroke Symposium, 09/01/14
- Cutting Edge Research: What’s Happening at Grady?, Grady Stroke Symposium, 09/01/15
- Research and Stroke: What Have We Learned?, Grady Stroke Symposium, 09/01/16
- Upcoming Stroke Research, Georgia Stroke Professional Alliance, 03/01/19
Timeline
Senior Clinical Program Manager
Vastrax, Inc.
03.2022 - Current
ENDOLOW Project Manager | Manager, Program and Res
Emory University School of Medicine, Department o
04.2018 - 03.2022
Clinical Research Coordinator IV
Emory University School of Medicine
09.2015 - 12.2018
Clinical Research Coordinator
Dekalb Neurology Associates, LLC / NeuroStudies.net, LLC
06.2010 - 07.2012
Bachelor of Arts -
University of Georgia