Judy Wilson

Judy Wilson Email and Phone Number

Principal Lead Data Manager | Data Designer | Clinical Data Management @ Cytel
Judy Wilson's Location
Malden, Massachusetts, United States, United States
Judy Wilson's Contact Details

Judy Wilson personal email

n/a
About Judy Wilson

Accomplished Clinical Data Management Professional with expertise ranging from end-to-end project management to hands-on operations for multiple, global trials in pharmaceutical, biotechnology and CRO environments. Broad knowledge of CDM processes, systems and best practices. Proficient technical skills of design, build, test and implementation. Proven record to build positive, internal and external relationships across multi-functional groups. Known for attention to detail and commitment to drive timely, compliant, high quality deliverables. Adaptable to changing priorities under tight timelines.Specialties* Project Management * Client Relationships * Process Improvement * Quality Management* Requirements Gathering * CRF Design * Database Design * Data Validation Specifications* Data Cleaning * Documentation * EDC Tools and Processes * Oncology Clinical TrialsCDM computer software experience* Oracle InForm and Central Designer * Oracle Clinical * Medidata Rave * ClinTrial* Wyeth Clinical Data Management Systems (CDMS) and Wyeth Remote Data Capture (RDC) * Adobe InDesign * eDesigner * Quicksilver * CaseLink * Perform Pro * SQL Assist * COSTART* MedDRA * WHO-Drug * Documentum Electronic Document Management System (EDMS) * MS Office (Word, Excel, PowerPoint, Outlook, Access) * MS Project * Lotus Notes * Groupwise* Service Management Suite (SMS) * Viewpoint * Sharepoint

Judy Wilson's Current Company Details
Cytel

Cytel

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Principal Lead Data Manager | Data Designer | Clinical Data Management
Judy Wilson Work Experience Details
  • Cytel
    Senior Clinical Data Manager
    Cytel 2013 - Present
    Cambridge, Ma, Us
    Perform clinical data management tasks from study start-up through database lock for both EDC and paper studies, focusing on data consistency and documentation of clinical research projects. Manage start-up activities such as protocol review, CRF development, database design and specification of data validations. Conduct study maintenance and final database lock activities such as data review/ discrepancy management, tracking/reporting of data status and data quality control. Liase between study center personnel and the client regarding clinical and/or technical issues to ensure data/operations consistency and adherence to best practices.
  • Accenture
    Study Designer - Eisai Medical Research
    Accenture 2010 - 2013
    Dublin 2, Ie
    Provided clinical data management expertise for the startup and update activities of both EDC (InForm) and paper (InDesign) studies for oncology and neuroscience clinical trials. Performed hands-on CDM tasks such as protocol review, CRF and database design, edit check specification, guideline documentation (CCGs) and User Acceptance Testing. Conducted project management activities (e.g., project planning, negotiation, coordination, tracking, quality review, issue escalation, execution) to drive key deliverables.
  • Accenture
    Database Design Project Manager At Wyeth/Pfizer
    Accenture 2006 - 2010
    Dublin 2, Ie
    Managed development and amendment of clinical trial databases for multiple, EDC, phase II-III oncology trials in Medidata Rave and Oracle Clinical. Served as Subject Matter Expert for processes and standards relating to CRF design, database design specifications, validation requirements and implementation of new technologies. Provided oversight of all study setup activities (design, build, program and QC) that were outsourced to multiple offshore Accenture teams in India (similar to CRO operations).
  • Accenture
    Data Management Liaison And Study Builder At Pfizer/Wyeth
    Accenture 2003 - 2006
    Dublin 2, Ie
    Managed end-to-end delivery of data management services from startup to database lock for phase I-II oncology studies in Oracle Clinical. Served as primary CDM contact who interacted with medical research, clinical operations, regulatory, biostatisticians, clinical programming and site coordinators. Acted in PM capacity of overseeing and coordinating CDM tasks that were outsourced to offshore Accenture teams (e.g., data cleaning/locking, lab/AE/SAE reconciliation, metrics reporting). Trained junior level DML staff. Created CRFs, CRF completion guidelines, clinical databases, data validation specification document and DMP.
  • Wyeth Research/Genetics Institute
    Senior Clinical Data Associate
    Wyeth Research/Genetics Institute 1997 - 2003
    Performed nuts-and-bolts tasks of CDM life cycle for global, orthopedic trauma and oral/maxillofacial, medical device studies. Designed/annotated CRFs, built clinical databases, developed CRF completion/data review/data entry/coding guidelines, identified edit checks, created/tested UAT data, produced and reviewed data/patient listings, generated/resolved data queries and modified clinical data accordingly, reconciled vendor/lab/SAE data, reported metrics/trends both ad-hoc and at team meetings, ordered CRF printing/shipment, tracked data flow for paper CRFs/electronic vendor data, collected protocol deviations and violations, addressed data audit findings and archived project files. Participated in development of DM working instructions. Presented at global investigator meetings/CRA training sessions.
  • Parexel International
    Senior Clinical Data Manager
    Parexel International 1993 - 1997
    Responsible for executing or overseeing all data management activities (preparing, validating, cleaning and locking clinical trial databases) in accordance to contractual timelines for multiple clients. Tasks included day-to-day activities of data review, query processing, form design, manual and automated edit check specification, UAT testing, adverse event/medication coding and tracking/reporting study status updates. Supervised 10 data managers. Presented at investigator and CRA/study coordinator meetings.

Judy Wilson Skills

Clinical Data Management Edc Clinical Trials Cro Data Management Oncology Oracle Clinical Gcp Clinical Research Pharmaceutical Industry Cdisc Biotechnology Inform Regulatory Affairs Software Documentation Quality Assurance Clinical Development Data Validation Medical Devices Ctms Fda Databases Crf Design Database Design 21 Cfr Part 11 Ich Gcp Validation Sas Sop Medidata Requirements Gathering Meddra Cross Functional Team Leadership Phase Forward Inform Sharepoint Medidata Rave Adobe Indesign

Judy Wilson Education Details

  • Temple University School Of Pharmacy
    Temple University School Of Pharmacy
    Regulatory Affairs And Quality Assurance
  • Washburn University
    Washburn University
    Computer Information Sciences
  • University Of Kansas
    University Of Kansas
    Anthropology
  • Southern Methodist University
    Southern Methodist University
    Sociology
  • Austin College
    Austin College
    Liberal Arts

Frequently Asked Questions about Judy Wilson

What company does Judy Wilson work for?

Judy Wilson works for Cytel

What is Judy Wilson's role at the current company?

Judy Wilson's current role is Principal Lead Data Manager | Data Designer | Clinical Data Management.

What is Judy Wilson's email address?

Judy Wilson's email address is jw****@****tel.com

What is Judy Wilson's direct phone number?

Judy Wilson's direct phone number is +161766*****

What schools did Judy Wilson attend?

Judy Wilson attended Temple University School Of Pharmacy, Washburn University, University Of Kansas, Southern Methodist University, Austin College.

What are some of Judy Wilson's interests?

Judy Wilson has interest in Quality Management, Aerobics, Collecting Antiques, Exercise, Community Service, Sweepstakes, Nascar, Home Improvement, Shooting, Reading.

What skills is Judy Wilson known for?

Judy Wilson has skills like Clinical Data Management, Edc, Clinical Trials, Cro, Data Management, Oncology, Oracle Clinical, Gcp, Clinical Research, Pharmaceutical Industry, Cdisc, Biotechnology.

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