Nadia Sukhraj-Singh

About Nadia Sukhraj-Singh

Clinical Trial Phases and Regulatory Affairs:Phase I-IV: Managing clinical trials across all phases.Regulatory Affairs: Handling regulatory submissions and ensuring compliance with FDA guidelines.Development of SOPs and Work Instructions: Creating and maintaining standard operating procedures.Contract and Vendor Management:Contract Negotiation: Managing the contract negotiation process, including RFI/RFP processes.Vendor Selection and Management: Selecting and managing vendors effectively.Budget Review and Negotiations: Reviewing, developing, and negotiating budgets.Site and Study Management:Site Qualification and Management: Overseeing site qualification, initiation, interim monitoring, and close-out visits.Study Management: Managing research facilities and clinical studies.Electronic Data Capture (EDC) and Source Data Verification (SDV): Ensuring accurate data capture and verification.Writing and Reporting:Scientific Writing: Writing clinical study reports, informed consents, and protocols.Publications Submissions: Submitting abstracts and publications for conferences.SAE Reporting: Reporting serious adverse events.Project and Data Management:Project Management: Overseeing project timelines, tracking, and execution.Data Management: Developing informed consent forms, clinical protocols, and case report forms (CRFs).Business Development and Training:Business Development: Engaging in sponsor trial management and site training.Team Leadership: Developing talent and ensuring high-quality work.Additional Responsibilities:Regulatory Submission: Preparing and submitting regulatory documents.Abstract Creation: Creating and submitting abstracts for conferences.Source Creation: Developing source documents for clinical trial

Experience

1. Sr Clinical Financial Planning and Analyst Specialist

   Dexcom

   Nov 2023 — Present

   Senior Clinical Financial Planning and Analysis SpecialistI lead multifaceted initiatives that support the successful financial and operational management of clinical research programs. My work bridges fiscal strategy with cross-functional collaboration to drive clinical and financial excellence. Core Responsibilities- Budget Strategy & Development• Designed and managed budgets for clinical departments, forecasting performance and identifying efficiency and revenue opportunities• Led budget setup and negotiated investigational site budgets to ensure alignment with trial goals- Financial Performance Analysis• Monitored KPIs across clinical and financial operations to assess and optimize performance• Executed financial modeling, variance analysis, monthly consolidations, and annual forecasting- Data Governance & Cross-Functional Collaboration• Maintained robust financial data systems for accuracy and accessibility• Partnered with clinical leaders, administrators, and finance teams to align fiscal strategy with operational priorities- Contract Management & Compliance• Negotiated and finalized Master Clinical Trial Agreements and individual site budgets• Ensured documentation and processes adhered to SOPs and internal governance standards- Operational Readiness Oversight• Supported global site budgeting and contracting with CROs and study teams• Managed contract timelines and readiness milestones to keep sites on track for activation- Protocol Development & SOP Alignment• Facilitated protocol refinement and ensured team-wide adherence to regulatory and institutional standards

Education

• Anthem College

  Associate's degree, NCMA

• Professional Career Development Institute ,LLC

  Diploma of Education, The Professional Medical and Dental Office Assisting Program

• Gwinnett Technical College

  Bachelor's degree, Business Administration, Management and Operations