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Accomplished, innovative, high-performing clinician and healthcare project management leader with extensive, wide-ranging phase I to IV planning through close-out, adult and pediatric, pharmaceutical clinical research and clinical operations experience. Expertise in Vaccines, Anti-Infectives, Rare Disease, Neuroscience, Oncology operational delivery of global clinical trials. Trained in all therapeutic areas. Demonstrated success overseeing strategic global programs, feasibility and start-up, budget development, trial scope and timeline management. SME with proven track record leading and developing global, cross-functional teams. Exemplary communication, leadership, stakeholder/KOL management, and strategic thinking skills. RN and MSc in Pharmaceutical Medicine. 17 years global trial management experience, 1.75+ yrs Vaccines, 1.5 yrs Rare Disease, 3 yrs Oncology, 5yrs Neuroscience, 6yrs other Infectious Diseases. 25+ years in pharmaceutical industry.• Accept challenges, Seek opportunities to remove barriers, Pivot quickly with shifting priorities, Influence without authority, Lead in areas of ambiguity• Partner with BARDA, NIH, co-Sponsors• Global Sr. ClinOps Lead for mRNA COVID-19 Vaccine (pediatric and adult), Infectious Disease (pediatric and adult), Rare Disease, Neuroscience, Oncology, driving operational strategies, data driven priorities and excellence in a matrix organization• Sr. Clinical Oversight Lead for COVID-19, Flu, RSV, CMV, Zika, EBV Vaccines global trials Unblinded Teams• Regulatory GCP audits, inspection prep• Contract Execution Strategy & Budget Management to Establish Priority site Master Contracts in conjunction with Budget and Legal Departments• Global Regulatory Submission Strategy development• Lead Global Country/Site Feasibility analyses, Population Presentation, Recruitment, Retention and Site Development management, site and hospital infrastructure assessment, Study Start-up management• Program, Study Strategic Planning• Business Development new compounds/new indications/program development• Template, Process and SOP development• Cross Functional Global Team Leadership, Training and Mentoring• Building and maintaining KOL relationships• Training of KOLs, PIs, TA Specialists, Pharmacists, Site Staff, Nurses• Study Clinician/Safety Clinician• Proactive Risk Identification, Risk Management, Inspection Readiness• Vendor selection, oversight• Cross-Program Coordination with platform prioritization • Functional lead for unblinded Clinical Trial Managers across Infectious Disease Programs
Eliassen Life Sciences
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Director, Senior Clinical Project ManagerEliassen Life Sciences May 2021 - Present*Contributed to the success of the largest pediatric mRNA vaccine trial conducted to date (as of June 2022)Contributed to Emergency Use Authorization (EUA) for mRNA-1273 (COVID-19 vaccine) in children ages 6 months to 11 years• Leads global cross-functional study teams and single point of accountability for operational delivery of multiple global clinical trials, adult and pediatric.• Leads global high priority, high profile, high stress, highly adaptable teams, pivoting quickly for maximum impact.• Senior Unblinded Oversight Lead for global Infectious Diseases vaccine trials, fulfilling a regulatory need.
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Director, Senior Clinical Project ManagerThe Evanston Group Feb 2020 - Feb 2022Chicago, Illinois, Us• Led global cross-functional study team and single point of accountability for operational delivery of multiple, Rare Disease clinical trials, including scope, budget and vendor oversight, risk management, quality on time delivery and Inspection Readiness. -
Director, Senior Clinical Project ManagerPfizer Feb 2017 - Dec 2019New York, New York, UsKey competencies include:• Pharmaceutical Medicine and Research• Feasibility Assessment• Site Selection• Regulatory Submission Strategy• Contract Execution Strategy• Recruitment• Site Development• Training/Mentoring• Site Initiation Visits• Investigator Meetings• Hospital Infrastructure/Inpatient/Outpatient Clinical Trials• Study Clinician/Safety Clinician• Cross-Functional Team Leadership• Proactive Risk Identification/Management• Cross-Program Coordination -
ClinicianPfizer Aug 2013 - Feb 2017New York, New York, UsClinician, Safety, Cardiovascular Metabolic | Clinician, Neuroscience Pain Research UnitEarly development Clinician Ph 1, 2, 3 and safety clinician for Ph 3 very ill, high risk subjects with 11,000 randomized subjects. Worked closely with all cross-functional team members as Primary Point of Contact for delivery of protocol (including, but not limited to, development operations, biology, chemistry, clinical pharmacology, statistics, drug safety, supply chain, regulatory, data management, contracts and outsourcing, 3rd party alliance partners, stakeholders and vendors).
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Senior Site Start-Up & Regulatory Project ManagerInc Research Oct 2012 - Aug 2013Raleigh, North Carolina, UsGlobal - Provides strategic operational oversight of all the project SSU activities, all activities from site selection through site activation-ready. Assumes responsibility on cross-functional SSU deliverables at the project level following the project requirements and the applicable plans.• Provide operational input to protocol development and study design• Serves as the primary global liaison during SSU.• Assists in the management of multifunctional leadso Site identification and qualification;o Clinical trial regulatory (submissions, communication to competent authorities/ethics committees import licenses, study maintenance submissions);o Essential document collection leading to site activation;o Site contract managemento Develops and manages integrated site start-up timelines; including plans to address potential timing risks/gaps. Reviews the project SSU budget against project milestones and budget to ensure project profitability. Takes corrective measures where necessary to keep project in line with budget and gross profit expectations.• Ensures the projects stay within contracted scope, timeline, and budget.• Prepares and presents overall SSU strategy and status at client meetings Escalates functional resourcing needs to senior management. Develops new business opportunities whenever possible participates in new business development activities including participation at client presentations.• Direct proposal preparation and bid defense activities as required for start-up functions. Collaborates on standards, processes, and expectations with internal and external customers. Drives functional project revenue, gross profit, and productivity targets. Develops and trains others on the use of project management tools and techniques spanning the project lifecycle. • Uses leadership skills and strong relationships to provide awareness of future issues and to promote a collaborative working environment and efficient problem solving. -
Global Senior Study ManagerExecupharm Jul 2007 - Oct 2012King Of Prussia, Pa, UsResponsible for delivery of the multiple operational aspects of clinical studies from feasibility through database release, with high-quality, timely and cost-effective data per GCP Guidelines and applicable regulations.Support effective study reporting and close-out; submission activities and audits/inspections.Liaise with members of the project team to include Clinical Protocol Manager (CPM), Project Data Manager (PDM), Lead Data Manager (LDM), Supply Chain Coordinator (SCC), Lead Clinical Protocol Writer (CPW), Clinician, Contracts & Outsourcing (C&O), IVRS Coordinator, Statisticians, Clinical Assay Group (CAG), U.S. region (USCO) Country Offices (PCO).Proactively identify and resolve study operations-related issues; prepare contingency plans.Vendor selection and management.Planning and Presenting at US and International Investigator Meetings.Liaise to initiate, review and approve study management components of study start-up budget, including per subject and ancillary investigator costs and clinical trial budget; approve payments to sites.Develop study level recruitment/retention strategy/plan oversee implementation of plan, including site-level plans, recruitment/retention tools, and advertising materials.Liaise to ensure timely database entry of clinical study data, distribution and resolution of data queries, coordinate endpoint collection, reconciliation and adjudication; communicate data timelines and drive progress for interim data locks.Accountable for study close out; provide project management for database lock and release activities, working with the LDM to ensure all timelines and quality goals are met.Continuous training. Mentor other Study Managers.Work to provide continuous improvement, risk mitigation strategies, dosing oversight strategies, inspection readiness. Ensure that studies are compliant with GCP, relevant SOPs, regulatory requirements, globally agreed processes, technologies and strategies.
Barbara Busby Education Details
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Hibernia CollegePharmaceutical Sciences -
Baylor University
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Hibernia CollegePharmaceutical Medicine
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Hibernia CollegePharmaceutical Sciences
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The University Of Texas Health Science Center At Houston (Uthealth Houston)Registered Nursing/Registered Nurse
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The University Of Texas Health Science Center At Houston (Uthealth Houston)Registered Nursing/Registered Nurse
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The University Of Texas Nursing School At HoustonNursing
Frequently Asked Questions about Barbara Busby
What company does Barbara Busby work for?
Barbara Busby works for Eliassen Life Sciences
What is Barbara Busby's role at the current company?
Barbara Busby's current role is Director, Senior Global Clinical Project Lead.
What is Barbara Busby's email address?
Barbara Busby's email address is bb****@****sen.com
What is Barbara Busby's direct phone number?
Barbara Busby's direct phone number is (813) 386*****
What schools did Barbara Busby attend?
Barbara Busby attended Hibernia College, Baylor University, Hibernia College, Hibernia College, The University Of Texas Health Science Center At Houston (Uthealth Houston), The University Of Texas Health Science Center At Houston (Uthealth Houston), The University Of Texas Nursing School At Houston.
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