Spearhead the development and communication of the corporate vision prioritizing quality for snapIoT's Decentralized Clinical Trial (DCT) Software as a Service (SaaS) platform to foster a cohesive delivery for global clients. Direct global team focused on product and project delivery. Ensure broader corporate commitments are achieved by promoting a results-driven work environment. Collaborate across Fortrea's broader organization to synchronize delivery requirements and enhance operational efficiency. Serve as the Subject Matter Expert (SME) for Regulatory and Quality Affairs by overseeing controlled documents, managing quality events, and facilitating audit hosting.Key Accomplishments: Engineered a comprehensive overhaul of the monthly invoicing process, resulting in the identification and resolution of invoicing discrepancies for 28% of active studies. Successfully captured and invoiced over $1M in previously unbilled activities as well as achieved a 100% invoicing accuracy rate by instituting a refined invoicing procedure. Implemented Key Performance Indicators for departments resulting in increased cross functional understanding. Instituted a monthly global all hands meeting to align disparate product, development operations, and project delivery teams.

In this role, I oversaw controlled documents, managed quality events, and orchestrated audit hosting, significantly reducing audit findings as the Subject Matter Expert (SME) for Quality Affairs. Addressing internal and external escalations, I ensured seamless service delivery and maintained client satisfaction. Playing a crucial role in addressing intense escalations, I actively participated in regulatory inspections. Mitigated operational delivery risk by ensuring cross functional teams aligned on priorities.Key Accomplishments: Implemented an audit methodology, leading to a 75% decrease in audit findings.  Led a comprehensive initiative to close inactive databases, resulting in a substantial monthly server cost reduction of 40%. Orchestrated the formulation and global dissemination of the corporate vision for snapIoT's Decentralized Clinical Trial (DCT) platform, encompassing eConsent, ePRO, eCOA, Telemedicine, and Mobile Nursing eSource.

Facilitating communication between internal operational teams and DCT vendors, I ensured timely and budget-conscious study deliveries. Developed tailored DCT tools for internal stakeholders, supporting successful business development. Conducting pipeline reviews, I proactively identified potential risks and implemented preemptive measures.Key Accomplishments: Recognized as an early core team member and actively participated in the launch of DCT services for LabCorp. Delivered impactful coaching to teams and clients on an entirely new service offering, while enabling the seamless continuation of studies during the challenges posed by the pandemic.

Addressing escalations and proactively identifying budgetary shortfalls, I collaborated with sponsors to develop corrective plans, leading to formal change orders. Managing studies across various phases, I oversaw a mega post-marketing safety review study and formulated study-specific Key Performance Indicators (KPIs), eliminating backlog within eight months. As the key point of contact for global clinical trials, I oversaw the entire lifecycle.Key Accomplishments: Successfully managed studies across various phases, including the oversight of a mega post-marketing safety review study. Formulated study-specific Key Performance Indicators (KPIs), resulting in the complete elimination of backlog within an eight-month timeframe. Spearheaded communication as the key point of contact for global clinical trials to oversee entire lifecycle from bid defense to eTMF transfer and closeout.

As a pivotal core team member, I played a key role in the successful launch of a revenue-generating service offering focused on the seamless delivery of clinical trial data. This initiative targeted assays not validated by Covance protocols.Key Accomplishments: Launched a certified clinical laboratory within a remarkable nine-month timeframe and strategically integrated into an existing commercial laboratory structure. Managed the commercial capability pipeline and overall corporate partnerships after laboratory's launch. Lead the creation of a tool used by a global team for all aspects of daily work, including reporting for ISO15189 compliance.

Pioneering a newly established role as the Onsite Representative for Covance Central Laboratories at a major pharmaceutical company, I actively shaped day-to-day activities and drove market share growth. Establishing robust relationships within the organization, I identified challenges and implemented effective solutions.Key Accomplishments: Attained significant success in transforming routine updates into highly interactive sessions for all participants by orchestrating quarterly lessons-learned meetings. Adopted and implemented successful model across the organization, while extending to other major pharmaceutical clients.

Commencing employment at Covance Central Laboratories, I focused extensively on Oncology and Endocrinology studies. Serving as the primary point of contact for all facets of central lab delivery, I demonstrated excellence in budget management responsibilities.Key Accomplishments: Played a key role in a small team tasked with developing a proactive budget management tool; efficiently identifying studies at risk of deviating within 5% of the contracted value.

Managed a hospital department in coordinating both professional and medical staff in the delivery of services. Reversed a negative net income of $6,000 to a positive $59,420 within 5 months. Audited and accounted for a charge variance of $500k, implemented process changes to prevent. Exceeded hospital FY budget by $1M by creating and implementing a marketing plan that increased new patient volume by over 20% resulting in a doubling of net income.