ECOA consulting Services

In this role, I directed four solution specialists representatives to expand product portfolio for large CRO clients. I coordinated efforts among Medidata sales, services, and development teas to increase sales and system utilization through partner-procured solutions. I initiated the development of relaltionships for rater training.A few noteworthy contributions in this tenure include: Enhanced product capabilities; demonstrated expertise in eCOA and trained solution sales… Show more In this role, I directed four solution specialists representatives to expand product portfolio for large CRO clients. I coordinated efforts among Medidata sales, services, and development teas to increase sales and system utilization through partner-procured solutions. I initiated the development of relaltionships for rater training.A few noteworthy contributions in this tenure include: Enhanced product capabilities; demonstrated expertise in eCOA and trained solution sales specialists to identify and capitalize high value business opportunitiesEstablished new communication channels with dormant customers,leading to contract renewals and revenue growth. Show less

I educated sponsors on IQVIA’s eCOA offering during bid defense and capabilities meetings. Additionally, I prioritized the product roadmap in collaboration with the eCOA development team and trained the business development team on eCOA-specific selling strategies. I reviewed all clinical protocols for eCOA solutions and shared relevant information with the proposal team. Furthermore, I coordinated with the DCT team for larger IQVIA team proposals and directed the development of a rater… Show more I educated sponsors on IQVIA’s eCOA offering during bid defense and capabilities meetings. Additionally, I prioritized the product roadmap in collaboration with the eCOA development team and trained the business development team on eCOA-specific selling strategies. I reviewed all clinical protocols for eCOA solutions and shared relevant information with the proposal team. Furthermore, I coordinated with the DCT team for larger IQVIA team proposals and directed the development of a rater training offering for IQVIA alongside the patient-centered endpoint team. I also played a role in staffing and hiring new IQVIA eCOA personnel and represented IQVIA as a company representative for the C-Path organization.Sent from my iPhone Show less

I provided expert insights to the clinical business development team, contributing to strategic initiatives. I maintained scientific integrity by performing eCOA protocol evaluations from sponsors. I delivered comprehensive eCOA training to sales team, ensuring compliance with requirements. I acted as Bracket's subject matter expert in capability and bid defense meetings ensuring alignment with sposors and regulatory requirements.

I managed the Clinical Solutions Group, overseeing its activities and staff. My responsibilities included analyzing client protocols to identify E-solutions tailored to their requirements and reviewing completed solutions for quality, efficiency, and regulatory compliance. As a subject matter expert for the e-clinical business development group, I successfully demonstrated software products to sponsors and CROs, resulting in the closure of 70% of development projects. Additionally, I developed… Show more I managed the Clinical Solutions Group, overseeing its activities and staff. My responsibilities included analyzing client protocols to identify E-solutions tailored to their requirements and reviewing completed solutions for quality, efficiency, and regulatory compliance. As a subject matter expert for the e-clinical business development group, I successfully demonstrated software products to sponsors and CROs, resulting in the closure of 70% of development projects. Additionally, I developed an e-clinical training program for new employees, ensured metrics and timelines were met, and designed reports to offer transparency into sponsor data. Proactively, I reviewed data, identified trends, and maintained accuracy. Moreover, I monitored eCOA studies from design to data lock to ensure quality and trained sites and CRAs in the use of eCOA devices and applications.Sent from my iPhone Show less

ePRO specialist, Clinical Operations, manager solutions development

As the overseer of clinical systems, I was responsible for reviewing and approving their implementation while managing a global cross-functional team and IT budget. Ensuring compliance with 21CFR standards, I meticulously evaluated the effectiveness of various clinical systems. Heading the Global Technology Team, I spearheaded the identification of data collection tools for trial use, assessed new technology and software, and conducted comprehensive vendor reviews, delving into financials and… Show more As the overseer of clinical systems, I was responsible for reviewing and approving their implementation while managing a global cross-functional team and IT budget. Ensuring compliance with 21CFR standards, I meticulously evaluated the effectiveness of various clinical systems. Heading the Global Technology Team, I spearheaded the identification of data collection tools for trial use, assessed new technology and software, and conducted comprehensive vendor reviews, delving into financials and business history. My role extended to managing the IT budget for Bayer North America’s product development group, where I meticulously monitored expenditures to align with predetermined budgets. Additionally, I supervised the EDC help desk, crafting and delivering training sessions and authoring SOPs to streamline global help desk operations. Serving as a crucial link between medical affairs and product development, I ensured clinical sites met internal requirements for participation in trials, thereby facilitating seamless collaboration across departments. Show less

As a seasoned professional, I have demonstrated proficiency in reviewing and approving clinical systems, leading global cross-functional teams, and managing IT budgets effectively. At Bayer North America, I meticulously reviewed clinical systems for 21CFR compliance and spearheaded the identification of data collection tools for trials while overseeing vendor reviews and financial assessments. Managing the IT budget for the entire product development group, I ensured adherence to planned… Show more As a seasoned professional, I have demonstrated proficiency in reviewing and approving clinical systems, leading global cross-functional teams, and managing IT budgets effectively. At Bayer North America, I meticulously reviewed clinical systems for 21CFR compliance and spearheaded the identification of data collection tools for trials while overseeing vendor reviews and financial assessments. Managing the IT budget for the entire product development group, I ensured adherence to planned budgets and supervised the EDC help desk, implementing comprehensive training programs and standard operating procedures. In previous roles, I excelled as a Senior Clinical Programmer Analyst, contributing to the design and development of Electronic Data Capture systems, facilitating technology transitions, and specializing in custom function development within the Rave environment. Show less