Clinical Project Management Professional | Communication ExpertAccomplished Clinical Research Professional with extensive expertise in driving the success of clinical studies through proactive, risk mitigated project management. Approaches efficient problem solving and risk mitigation by bridging and implementing best practices from the perspective of both the clinical research site and clinical research organization experience. Ensures effective cross-functional teamwork among project team members including both internal and external stakeholders. Proactively leads both quality control and risk assurance activities to ensure project deliverables are audit ready and meet regulatory, organization and client requirements. Strong organizational and communication skills, with a deep understanding of ICH-GCP guidelines and experience in diverse therapeutic areas. Committed to optimizing study operations, enhancing data integrity, and supporting effective stakeholder communication. Experienced in clinical programming, CTMS integrations, electronic data capture and digital health. Extensive knowledge of TMF processes and clinical documentation.
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Clinical Project ManagerSyneos Health-Cro Oct 2021 - Feb 2024United States• Facilitated companion diagnostic product development through effective meeting management and stakeholder coordination.• Supported contract negotiations and monitored project execution for timely deliverables.• Collaborated with internal and external teams to ensure compliance with clinical protocols.• Oversaw vendor qualification and onboarding for clinical diagnostic alignment.
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Senior Clinical Study AssistantIndiana University School Of Medicine Cro Jun 2013 - Mar 2021Scheduled analysis such as RECIST measurements in tumor clinical trials. This includes but is not limited to study setup, scheduling, maintenance of study information in SharePoint database, maintenance of subjects' records, communication with imaging technologists, and research coordinators/nurses/etc., and billing for services.Screened patients to determine study eligibility criteria by reviewing patient medical information or interviewing subjects.Obtained and organized data for test results, diaries/cards, or other necessary information for the studies.
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Clinical Data CoordinatorIndiana University School Of Medicine Cro Jan 2019 - Apr 2020Indianapolis, Indiana, United StatesExtracted data from source documents to complete case report forms and answer queries in a timely mannerIdentified quality and performance improvement opportunities with staff in the development of action plans to improve quality.Facilitated in the development and coordination of program-related events and workshops for patients with Multiple MyelomaWorked with department supervisor/manager to assist and train new hires in the research department/across all specialtiesImplemented industry-initiated and investigator -initiated oncology clinical research studies.
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Clinical Research CoordinatorMidwest Eye Institute Oct 2019 - Feb 2021Carmel, Indiana, United StatesInitiated 32 gene prescreening visits in two months, documented and maintained accurate records of all research activities, AE (adverse events) monitoring and SAE (serious AEs) reporting.Conducted clinical trials with multi tasks, data entry and resolved queries via EDC systems such as Medidata, Medrio, Clin Trak ,DrugDev, Clinergize.Conduct other delegated tasks such as unmasked role of study drug dispensation, vision check and IOP measure tasks for subjects in ophthalmology studies. Obtained and assessed vital signs, ECG and handling bodily fluids including whole blood, conduct biospecimen collecting, handling, packaging, and shipping per lab manual.Conducted BCVA masked and unmasked vision acuity exams per protocol.
Stephanie D. Education Details
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Buisness Communication -
Indiana University Purdue University IndianapolisMass Communication/Media Studies
Frequently Asked Questions about Stephanie D.
What is Stephanie D.'s role at the current company?
Stephanie D.'s current role is Clinical Project Manager with 10 years of experience, excelling in negotiation, vendor management, and cross-functional team leadership..
What schools did Stephanie D. attend?
Stephanie D. attended Indiana University–purdue University Indianapolis, Indiana University Purdue University Indianapolis.
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Stephanie A. Shaw, Ed.D., MPA, MBA
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Stephanie D
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Stephanie D.
Denver Metropolitan Area -
Stephanie D.
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Stephanie D.
New York, Ny
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