Senior Clinical Study Set-Up Lead

Ernest Brown

******.*******@*****.*** 504-***-**** MARIETTA, GA

WORK EXPERIENCE

Senior Set-Up Specialist IQVIA

January 2021 - June 2024 • Durham

Study Design Lead II LabCorp

January 2021 - June 2024 • Indianapolis

- Interpreted and translated clinical protocol requirements into clear, data-ready Statements of Work (SOW) to guide study setup and documentation. - Entered, organized, and validated study requirements and parameters across tracking systems to ensure completeness and accuracy. - Performed quality checks against source and regulatory documents, resolving discrepancies and updating records per SOPs and timelines. - Partnered with cross-functional teams to prioritize tasks and maintain schedule adherence, delivering audit-ready documentation. Senior Set-Up Specialist IQVIA

April 2012 - December 2020 • Durham

- Maintained start-up timelines and task trackers with precise, on-time data entry and updates to meet study milestones. - Configured and reviewed study databases against source documentation to confirm correct field mappings and alignment with protocol requirements. - Conducted data verification and QC, documented findings, and resolved issues in accordance with SOPs and change-control procedures. - Assisted in developing database design documents and standardized templates to support consistent, audit-ready study setup. Senior Design Lead Labcorp

April 2012 - January 2020 • Atlanta

- Produced comprehensive SOWs by synthesizing protocol, client requirements, and Labcorp process standards into structured, traceable specifications. - Captured and maintained study parameters, test lists, and logistical details in centralized trackers to support accurate downstream data entry and reporting. - Advised clients on study setup best practices, documentation standards, and data integrity requirements to ensure compliance and quality. - Executed document reviews and controlled updates, promptly reflecting approved changes to keep stakeholders aligned with current study design. Research Assistant Morehouse School of Medicine

August 2009 - April 2012 • Atlanta

project related issues. Lead set-up activities and communications with client and or sponsor counterparts. Managed the entire set-up process for one region with the oversight of project manager. Mentored and assisted in training more junior staff. Contribute to project improvement initiatives. Coordinated information and communications for setup activities with clients and internal customers to ensure approvals are met and launch is successful. Coordinated set-up activities across data management, logistics, clinical trial materials, laboratory testing and specimen management. Ensured work is in line with standard operating procedures, policies and good practice. Collected and reviewed regulatory documents from clinical sites and communicated with sites regarding trial start-up, conduct, and close-out activities. Liaised with Clinical Operations and vendors regarding tracking information. Managed and tracked study specific payments and clinical and non-clinical supplies. Generated and reviewed management reports from internal tracking systems. Developed research protocols and procedures to produce accurate results. Collected research data through experimentation, surveys and leading focus groups. Conducted tests on equipment and instruments for quality. Participated in lab meetings and project presentations. Analyzed results using analytical software and created reports.

EDUCATION

Spring Hill College

August 1998 - May 2002 Bachelors, Bachelor of Science in Biology Spring Hill College

August 1998 - May 2002 Bachelors, Bachelor of Science-Biology NOTABLE SKILLS

Tracking Systems Self Motivation Regulatory Documents Time Management Development Of Database Design Task Prioritization Adaptability Strong Work Ethic Potential Professionalism Strategic Thinking Improvement Clinical Supplies Project Planning Standard Operating Procedures

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