Multi-faceted, analytical and results-driven Clinical Data Associate and Business Development professional bringing 24+ years of work experience with expertise in leading data management activities for clinical studies, comprising the design, development, and management of electronic databases as well as implementation of data management processes and plans. Proven experience in reviewing SOPs and WIs as well as in serving as the project and client liaison while overseeing project specific data management status, cycle time, and productivity metrics. Demonstrated ability to close large complex deals, exceed sales goals and work well with both internal and external stakeholders along with proven track record of meeting and exceeding sales quota. Resilient with the ability to constructively work in a fast-paced environment with a unique mix of strategy and tactical planning skills coupled with highly effective communication and motivational skills. Key contributions and skills include:• At Bluegreen Properties - Emerged as the Top Sales Agent from 2004 to 2007Key Skills: Clinical Data Management • CRO Management • Data Quality • Clinical Trials & Research • Electronic Data Capture • Good Clinical Practice (GCP) • Instructional Design • Audits & Inspections • Standard Operating Procedure • Work Instructions • Sales & Business Development • Entrepreneurship • Pharmaceutics • Cross-functional Coordination • Vendor Management • Communication Skills • Real Estate • Team LeadershipIT Skills: MS Windows XP, MS Word, MS Excel, Internet Explorer, Outlook, Netscape, Rightfax, MS PowerPoint, Inform Database, MeetingPlace, CASCADE, Medidata Rave, Trial Works, and LivelinkTherapeutic Experiences: Cardiovascular - Circulatory System, Vascular Occlusion • Dermatology - Psoriasis • Endocrinology/Metabolism - Diabetes Mellitus, Type 2 • Infectious Disease - Infection, Cytomegalovirus • Nephrology - Kidney Disease • Oncology - Cancer, Acute Myeloid Leukemia; Cancer, Basal Cell Carcinoma; Cancer, Lung; Cancer, Lung Non-Small Cell; Cancer, Sarcoma • Respiratory - Rhinitis, Seasonal Allergic • Skeletal Diseases - Mobility Impairment • Urology - Urinary Frequency
-
Data ManagerPharpoint Research, Inc. Apr 2021 - PresentDurham, Nc, Us -
Clinical Data Associate IiiInc Research 2015 - 2020Raleigh, North Carolina, UsINC Research/inVentiv Health/Syneos Health is the only fully integrated end-to-end clinical and commercial solution organization.• Review and adhere to the requirements of Study-Specific Clinical Data Management plans for assigned projects domestically and globally while meeting deadlines by prioritizing workload and maintaining flexibility.• Communicate project status and progress to study leads and managers as well as mitigate regulatory risks by ensuring compliance with clinical data management plan requirements.• Perform review of discrepancy output and validation listings based on data entered as well as review and generate ad hoc listings, reports, and quality control documentation to facilitate validation of the clinical database.• Serve as the Lead CDA on numerous studies, including global studies along with providing training and delegating tasks.• Review SAS listings and reports, SAE reconciliations, and third-party vendor data as well as participate in internal and external project team meetings.• Support database testing, CRF/eCRF data review (query creation, closure, re-queries), listing review and QC procedures including data management quality review for electronic data capture (EDC) and paper studies.• Assist in several database locks, along with all database lock tasks and database user acceptance testing for edit checks. -
Clinical Data Associate IiiPpd 2013 - 2014Wilmington, Nc, UsA global CRO providing comprehensive, integrated drug development, laboratory and lifecycle management services.• Interacted with inter-organizational and outside customer contacts as well as with central and external laboratories, CROs, etc.• Assisted in design of protocols and development of relevant quality standard specifications according to protocol and approved standards along with participating in user acceptance testing.• Trained less experienced CDAs to assist with general and study-specific issues as well as data management procedures.• Oversaw, monitored, and tracked quality of vendor data management deliverables, ensuring audit practices were in place to validate the quality of database content as well as external electronic data transfers.• Performed data cleaning with minimal supervision and in accordance with GCPs and SOPs/WPDs along with performing activities such as CRF design, database design and data validation manual creation.• Generated, tracked, and resolved data clarifications and queries as well as resolved and updated data discrepancies. -
Clinical Data Associate IiPpd 2011 - 2013Wilmington, Nc, Us• Supported data abstraction and data entry of assigned studies as well as gathered and entered data in accordance with SOPs and protocol specific processes. • Performed advanced aspects of the data cleaning process, with a high degree of accuracy and in accordance with GCPs and SOPs/WPDs as well as data listing reviews, and reconciliation of serious adverse events and third party vendor data.• Assisted Programmers, Biostatisticians and other Clinical, DSPH, Regulatory and Project Management staffs to meet project deliverables and timelines for non-routine clinical data acquisition, quality checking and reporting.• Reviewed data listings for accuracy and consistency as well as analyzed and resolved data validation and management reports.
-
Senior Document TechnicianPpd 2008 - 2011Wilmington, Nc, Us• Performed multiple studies by sorting, filing and creating files and provided primary records management and file room support.• Worked on special projects as assigned by Records Coordinator/Supervisor as well as assisted in reviewing inventory and documentation of all records held by off-site vendors.• Developed and maintained health information networks as well as maintained data on patient safety, patterns of disease, and disease treatment and outcome.• Provided service to internal customers by fulfilling file requests as well as prepared transfers and off-site archival tasks.
-
Project AssistantPpd 2007 - 2008Wilmington, Nc, Us• Assisted with the identification of potential investigators as well as development and distribution of initial protocol packets.• Reviewed regulatory documents for proper content in accordance with FDA, ICH/GCPs, PPD and Client Company appropriate SOPs prior to submission to the Project Manager, central IRB, Regulatory Affairs and clients.• Oversaw execution and distribution of study related information, and provided project updates to clients, clinical study teams and other departments as well as resolved outstanding regulatory issues identified through regulatory and investigator file reviews.• Developed and maintained assigned data points in CTMS database according to established conventions and tools.
Kenny Stone Education Details
-
University Of MarylandSociology -
Cape Fear Community CollegeOverview Of Contract Research Organizations Course
-
Job TrainingCompleted The Following Trainings:
Frequently Asked Questions about Kenny Stone
What company does Kenny Stone work for?
Kenny Stone works for Pharpoint Research, Inc.
What is Kenny Stone's role at the current company?
Kenny Stone's current role is Data Manager.
What schools did Kenny Stone attend?
Kenny Stone attended University Of Maryland, Cape Fear Community College, Job Training.
Free Chrome Extension
Find emails, phones & company data instantly
Download 750 million emails and 100 million phone numbers
Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.
Start your free trial