Drove the growth strategy for a startup psychiatry practice, leveraging expertise in clinical operations and management. Defined clear path towards scalability, designing core processes and systems around efficiency, profit, and cost savings.
• Drove organic growth in 10 months by renegotiating insurance contracts and driving operational improvements.
• Revamped growth plan by shifting focus from rapid acquisition to building scalable processes and practices.
• Managed key vendors, managing contracting, and monitoring performance quality and timelines.
• Created standard operating procedures (SOPs) and documentation to streamline onboarding for new hires.
• Oversaw daily operations across the practice, manage budgets, personnel, billing, and marketing.
• Led direct reports, increasing team capabilities via mentoring, performance management, and conflict resolution.
• Hired new talent for critical roles including a healthcare practitioner, billing specialist, and office manager.

Supervised clinical supply chain operations for Teva's first generic / biosimilar therapeutic area as part of the Clinical Study Team (CST). Set up new clinical supply study supply chain processes and SOPs. Guided collaboration among cross functional study teams to drive clinical development operational excellence.
• Project managed high-priority clinical trials, monitoring, triaging, and addressing risk and interdependencies.
• Directed global supply chain design and logistics for 5 global biosimilar programs, including definition of clinical study timelines, kit design, supply planning, and outsourced CSC vendor selection.
• Developed and led direct reports, managing resource allocation and championing a culture of inclusivity.
• Owned the CRO and supply vendor evaluation and internal management process including subcontractor approval, outsourcing, and quality compliance with ICH, GCP, GMP, and GDP guidelines for clinical supply activities.
• Accountable for all aspects of budg

Oversaw global clinical trial supply chain operations for studies across therapeutic areas, ensuring timely and compliant provision of materials across transportation and distribution networks.
• Delivered over 5 study implementation plans for cost-effective and risk adjusted supply plan based on demand. Updated plan in accordance with real-time supply chain data and suggested necessary changes in protocol.
• Supervised multimillion-dollar logistics budgets, working with Finance on accurate and timely payment of invoices.
• Sourced and vetted global vendors as primary contact for management, contracting, and supply chain activities.
• Monitored quality of vendor deliverables while adhering to schedule, budget, and scope. Managed invoices.
• Spearheaded design of the Interactive Response Technology (IRT) platform, creating customized systems for set-up, testing, and maintenance of individual studies.
• Built SOPs and risk protocols across the supply chain cycle including alternati

Supervised clinical operations for global drug trials as part of the Clinical Study Team (CST) from Phase I drug development through Phase IV. Ensured studies adhered to timelines, budgets, and ICH / GCP compliance standards.
• Supported study planning, development and site selection, and study startup activities.
• Partnered with cross-functional stakeholders in Procurement, Supply Chain, Regulatory, Pharmacovigilance and other departments to drive alignment and ensure quality standards.
• Led vendor management including contracts, performance quality metrics, and invoice review.
• Developed SOPs while maintaining alignment with operational plans and activities for assigned studies.
• Developed strong knowledge of clinical research regulatory requirements (including GCP and ICH). Facilitated document review and collaboration for protocol and amendments including informed consent.
• Monitored site close-out activities including reconciliation and archiving, IP / sample disposal,

• Led regional workstreams for global clinical trials in North America and Asia and supported clinical project managers.
• Provided operational expertise, support, and oversight of CROs for studies in various phases and therapeutic areas.
• Ensured timely and accurate reporting of study data at the regional level.

• Served as primary point of regional contact for COMs / SACOMs, vendors, and other functional team members.
• Led on-time execution of study deliverables including maintenance and close out activities, regulatory and protocol documents, clinical input, SAE reports, data cleansing and analysis, budget analysis, and retrieval reports.
• Partnered with internal and external stakeholders to facilitate Phase III global oncology study.
• Ensured quality and consistency of research data from drug discovery and startup through database lock.

On assignment with Pfizer

Clinical Research Associate responsible for site monitoring visits.