Jackie Dye

Jackie Dye Email and Phone Number

Director, Clinical Data Management @ EyeBio
Cambridge, MA, US
Jackie Dye's Location
Cambridge, Massachusetts, United States, United States
Jackie Dye's Contact Details
About Jackie Dye

I am a Biometrics and Data Management (DM) executive with over 24 years of proven success in the Biotech and Pharmaceutical industry. Innovative business reformer, with 15 years in business process consulting and 20+ years in Data Management / Data Science technology development, planning and implementation. Driven to produce positive team culture and healthy working atmosphere, within Biometrics/DM department and across all Clinical Development functional areas. My expertise is in: • Clinical Data Management • SAS programming• CDISC, CDASH, SEND, SDTM and ADaM standards• Medidata RAVE, Medrio, InForm, TrialMaster, Oracle Clinical• Change Management • Project Management• Regulatory submission activities • Operational Excellence

Jackie Dye's Current Company Details
EyeBio

Eyebio

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Director, Clinical Data Management
Cambridge, MA, US
Jackie Dye Work Experience Details
  • Eyebio
    Director, Clinical Data Management
    Eyebio
    Cambridge, Ma, Us
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  • Sdc (Statistics & Data Corporation)
    Senior Director, Clinical Data Management (Cdm)
    Sdc (Statistics & Data Corporation) 2023 - Present
    Tempe, Arizona, Us
    Oversee clinical data management operations, ensuring operational excellence, on time and quality-based deliverables and client service excellence. Promotes, demonstrates and mentors team in regard to vision, mission, core values and quality. Actively supports business development in capabilities presentations to prospective and current clients. Effectively manages clinical study budgets and change management processes. Member of leadership team for department level strategic planning.
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  • Deciphera Pharmaceuticals
    Senior Director, Head Of Clinical Data Management
    Deciphera Pharmaceuticals 2020 - 2023
    Waltham, Massachusetts, Us
    Organize the CDM department as a cohesive team, contributing to the CDM activities of four Clinical Development programs and involving more than twenty clinical trials. I plan and drive the CDM vendor and technology strategy and am responsible for the selection and implementation of innovative data analytics and RBQM technologies to automate and reengineer the data acquisition and clinical data workflow, offering solutions to internal Deciphera clinical/medical reviewers, CDM and clinical operations staff, as well as external service providers.
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  • Immunogen, Inc.
    Director, Head Of Clinical Data Management
    Immunogen, Inc. 2017 - 2020
    North Chicago, Illinois, Us
    Established Clinical Data Management department; I drove the planning and execution of CDM activities across all trials in clinical development programs and put SOPs in place for the department. Accountable for the data quality and data integrity, I implemented three different data visualization/analytic solutions to streamline the data review work flow, provide visualizations for clinical and operational insights and ensure GCP compliance. Piloted two RBQM solutions on Phase III Ovarian Cancer clinical trials.Responsible for the successful database locks of the mirvetuximab soravtansine Phase I, FORWARD I and FORWARD II clinical trials and the database deployments of MIRASOL and SORAYA.
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  • Infinity Pharmaceuticals
    Head Of Data Management
    Infinity Pharmaceuticals 2016 - 2017
    Cambridge, Massachusetts, Us
    Planned and directed clinical and nonclinical DM activities over multiple drug programs, overseeing a department of Data Management and DM Systems staff, contractors and consultants. I was also accountable for Contract Research Organization (CRO) and service providers’ performance related to DM and SDTM conversion.
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  • Accenture
    Manager, Clinical Programming
    Accenture 2012 - 2015
    Dublin 2, Ie
    I directed global statistical programming activities to deliver high quality clinical datasets and outputs (including ADaM datasets and TLFs for study, ISS and ISE projects) within time and cost allocated. I represented ADaM programmers on client study teams and as a point of escalation on projects managed by lead programmers.
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  • Premier Research Group
    Sr. Clinical Data Coordinator
    Premier Research Group 2011 - 2012
    Morrisville, Nc, Us
    I led data cleaning teams across multiple global submission studies. I also advised clients on budgetary and resource forecasting for EDC studies and represented Clinical Data Management in bid defense meetings with new clients.
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  • Accenture
    Supervisor, Cdm, Clinical Data Project Manager
    Accenture 2004 - 2011
    Dublin 2, Ie
    I drove Pfizer's (formerly Wyeth) CDM study activities to meet timelines, milestones and SLAs. I ensured high-quality data delivery for clinical studies, including large scale, long-term, oncology submissions. I led a team located in India, and managed communication among global clinical study team members, vendors and CDM services. I was known for turning struggling teams around to effectively manage workload and track progress in metrics and quality.
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  • Medpace
    Sas Programmer / Database Builder / Statistical Analyst
    Medpace 2000 - 2004
    Cincinnati, Oh, Us
    I wrote and validated analysis and table and listing programs in SAS, according to the sponsor’s standards. I programmed edit checks and developed specifications and programs to integrate external data, and mapped databases to sponsor or SDTM standards. I prepared the Case Report Form Tabulations section of NDAs for paper and electronic submissions (CTD and eCTD).
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Jackie Dye Skills

Clinical Data Management Data Management Oracle Clinical Edc Cro Pharmaceutical Industry Clinical Trials Oncology Gcp Clinical Research Sas Programming Software Documentation Clinical Development Regulatory Submissions Project Management Leadership Validation Cro Management Cdisc Sdtm 21 Cfr Part 11 Electronic Data Capture Process Improvement Operational Excellence Database Design Meddra Computer System Validation Crf Design Medidata Training Vaccines Pl/sql Cross Functional Team Leadership User Acceptance Testing Change Management Data Integration Bpo

Jackie Dye Education Details

  • University Of Dayton
    University Of Dayton
    General

Frequently Asked Questions about Jackie Dye

What company does Jackie Dye work for?

Jackie Dye works for Eyebio

What is Jackie Dye's role at the current company?

Jackie Dye's current role is Director, Clinical Data Management.

What is Jackie Dye's email address?

Jackie Dye's email address is ja****@****gen.com

What is Jackie Dye's direct phone number?

Jackie Dye's direct phone number is +178189*****

What schools did Jackie Dye attend?

Jackie Dye attended University Of Dayton.

What skills is Jackie Dye known for?

Jackie Dye has skills like Clinical Data Management, Data Management, Oracle Clinical, Edc, Cro, Pharmaceutical Industry, Clinical Trials, Oncology, Gcp, Clinical Research, Sas Programming, Software Documentation.

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