Jackie Dye Email & Phone Number

Cambridge, Ma, Us

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.

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.

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.

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.

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.

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.

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.

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).