Hunter McDaniel
Fortrea Inc (Formerly LabCorp)
Broussard,LA
1
Language
1
Certification
11
years of professional experience
Accomplished clinical trial manager with extensive experience leading end-to-end global clinical research studies. Proven expertise in operational strategy, risk mitigation, and financial management across diverse therapeutic areas. Dedicated to driving cross-functional excellence and delivering high-impact clinical milestones.
Work History
Clinical Trial Manager III
4 Years 8 Months- Provided leadership for end-to-end clinical delivery across studies/programs/portfolios, ensuring alignment with enterprise and client objectives.
- Led global risk strategy, proactively identifying, mitigating, and resolving complex, cross-study issues with executive-level escalation as needed.
- Developed global risk strategy, identified and mitigated complex, cross-study issues, and escalated to executives.
- Managed study/program-level financials, focusing on forecasting, margin optimization, and global resource strategy.
- Defined global country/site strategies, optimizing feasibility, activation, and recruitment across diverse geographies.
- Oversaw critical start-up and regulatory pathways, ensuring quality, speed, and compliance in all phases.
- Ensured excellence in global operations, including vendor ecosystems, monitoring models, patient safety, and data integrity.
- Led inspection readiness across projects/programs, achieving audit/inspection success and fostering continuous quality improvement.
- Served as senior client partner, leading governance, influencing strategy, and shaping long-term partnerships.
- Led and developed clinical trial manager teams, building high-performing, globally aligned capabilities
- Contributed to business growth through leadership in proposals and strategic initiatives
Project Manager, Start-up
1 Year 1 Month- Oversaw Investigator Package compilation and green light approval regionally and/or globally. Proactively identified and escalated any risks to meeting deliverables. Propose effective mitigation plans, as applicable
- Managed site activation and maintenance progress, expectations, and deliverables to align with project goals
- Developed site activation and maintenance strategies in conjunction with the Project Lead, other functional groups and the client to ensure start-up and maintenance deliverables are completed within agreed project timelines and in accordance with client's expectations
- Oversaw submissions and approvals from ethics and regulatory bodies, coordinating responses to queries to meet required timelines
- Oversaw ethics and regulatory bodies' submission and approval status. Coordinate addressing queries ensuring required timelines are met
- Proactively identified and escalated any risks to meeting deliverables
- Facilitated cross-functional teamwork among project members and external services to enhance collaboration and achieve project objectives
Associate Project Manager II, Start-up
2 Years 3 Months- Developed a site activation and maintenance strategy in conjunction with the Project Lead, other functional groups and the client to ensure start-up and maintenance deliverables are completed within agreed project timelines and in accordance with client's expectations
- Proactively managed site activation and maintenance progress, expectations and deliverables
- Clarified client expectations for deliverables/milestones and liaised with functional teams to create and modify site activation timelines throughout project lifecycle
- Oversaw submission and approval status with ethics and regulatory bodies, coordinating query responses to meet required timelines
- Oversaw Investigator Package compilation and green light approval regionally and/or globally. Proactively identified and escalated any risks to meeting deliverables. Developed effective a mitigation plan
- Oversaw ethics and regulatory bodies' submission and approval status. Coordinated addressing queries ensuring required timelines are met
- Facilitated cross-functional teamwork among project members and external ancillary services to enhance collaboration and project alignment
Centralized Start Up Lead
1 Year 3 Months- Oversaw Investigator Package compilation and green light approval regionally and/or globally. Proactively identified and escalated any risks to meeting deliverables. Proposed effective mitigation plan, as applicable
- Managed maintenance progress and deliverables, ensuring alignment with project expectations
- Developed an amendment submission and approval strategy in conjunction with the Project Lead, other functional groups and the client to ensure maintenance deliverables were completed within agreed project timelines and in accordance with client's expectations
- Proactively managed maintenance progress, expectations and deliverables
- Oversaw Investigator Package compilation and green light approval regionally and/or globally. Proactively identified and escalated any risks to meeting deliverables. Proposed effective mitigation plan.
- Monitored regional Green Light (GL) approval status, identifying and escalating risks to deliverable timelines
- Facilitated cross-functional teamwork among project members and external services, enhancing collaboration and efficiency
- Contributed to a Start-Up Plan if required, oversaw Investigator Package compilation, green light approval and contributed to a cross functional team ensuring that sites achieve Ready to Enroll status on time
Clinical Research Regulatory Specialist
2 Years 1 Month- Performed regulatory responsibilities for active studies including: preparation of yearly continuing reviews for Institutional Review Board (IRB) submission, submission of study amendments and reportable information to Institutional Review Board (IRB), maintenance of an accurate and up-to-date site regulatory binder, involvement in site monitoring visits, and completion of site documentation during study close out visit
- Performed study start-up tasks including: submission of appropriate initial trial documents to Institutional Review Board (IRB), submission of contract and budget documents for internal approval, participation in negotiation of confidentiality agreements, conduction of informed consent negotiations, completion of regulatory documents for sponsor approval, completion of site selection questionnaires, and coordination of site initiation visits
- Trained and mentored new regulatory coordinators on study start-up processes and other regulatory tasks.
- Assisted in creating and maintaining departmental standard operating procedures to support regulatory compliance and operational consistency
Associate Clinical Research Coordinator
1 Year 7 Months- Managed regulatory responsibilities including preparation of yearly continuing reviews for Institutional Review Board (IRB) submission, submission of study amendments and reportable information to IRB, maintenance of accurate site regulatory binder, participation in site monitoring visits, and completion of documentation during study close-out visits
- Coordinated studies as the lead and back-up study coordinator across various trials.
- Coordinated study tasks such as transcribing data into electronic data capture systems, collecting and processing biological samples, screening and consenting patients, processing and shipping biological specimens, conducting National Institute of Health Stroke Scales and Frailty Assessments, and attending investigator meetings and site initiation visits.
- Conducted study start-up activities including submission of initial trial documents to the Institutional Review Board (IRB), obtaining internal approval for contract and budget documents, negotiating confidentiality agreements, facilitating informed consent negotiations, completing regulatory documents for sponsor approval, finalizing site selection questionnaires, and coordinating site initiation visits.
Data Coordinator
1 Year 2 Months- Managed data tasks: transcribed data into electronic data capture systems, acquired patient data for internal screening logs, generated screening logs and trial documentation, participated in investigator meetings and site initiation visits
- Conducted laboratory tasks: collected biological samples from biopsies and blood draws, processed in-house specimens, coordinated shipment of biological specimens
- Coordinated data collection and entry for patient records, ensuring accuracy and compliance with healthcare standards.
- Managed data integrity by conducting regular audits and implementing corrective measures as needed.
- Collaborated with cross-functional teams to streamline reporting processes and enhance data accessibility.
Engineering Technician 4
2 Months- Assisted in the development of a daily work plan to install and remove the recorders from assigned monitoring sites
- Maintained Tracking of Projects System (TOPS) to ensure accurate project monitoring and reporting
- Assisted the District Laboratory field crew in handling augers, taking routine samples, and maintaining equipment
- Became familiar with Department procedures, policies, standards and specifications as related to the processing of construction-related documents such as partial and final estimates, test reports, and materials audits (2059); assist higher-level technicians in a Project or District Laboratory Engineer's office engaged in these tasks
- Learned basic testing procedures and operation of testing equipment for quality assurance testing of construction and maintenance materials such as soils, aggregate, asphalt binders, geo-textiles, cement, metals, soil additives, etc.
- Provided assistance to senior inspectors in performing precise measurements and executing field tests for quality assurance.
- Gained proficiency in surveying equipment and field terminology to support Department/Section procedures
- Utilized data collection and review equipment to verify completeness and quality of pavement and bridge condition data
- Performed basic math computations and measurements
Graduate Teaching Assistant
11 Months- Was the instructor of calculus-based and algebra-based undergraduate physics laboratories and recitation courses.
Education
Bachelor of Science (BS) - Physics
Therapeutic Experience
Cardiovascular
- Hypertension (Device)
- Pulmonary Arterial Hypertension (Phase I, II)
- Cardiovascular Outcomes Studies (Phase IV)
- Atherosclerosis (Phase IV)
- Peripheral Artery Disease, Peripheral Artery Occlusive Disease (Device)
- Coronary Artery Disease (Device, Other)
- Acute Myocardial Infarction (Device)
- Carotid Artery Disease (Device)
- Heart Failure, Left Ventricular Dysfunction (Device)
- Dysrhythmia, Atrial Fibrillation (Phase IV, Device)
- Stroke, Cerebrovascular Accident, Transient Ischemic Attack (Phase IV)
- ST-elevation myocardial infarction(Device)
- Congestive Heart Failure (Phase III, IV, Device)
- Rare Disorders – Amyloid Cardiomyopathy (Phase II)
Infectious Disease
- COVID-19 (Phase I, II, III)
Oncology
- Head & Neck – Squamous Cell Cancer (Phase II)
- Melanoma (Metastatic) (Phase I, II)
- Non-Small Cell Lung Cancer (Phase I, II, III)
- Small Cell Lung Cancer (Phase I, II, III)
- Multiple Solid Tumors (Phase I)
- Renal Cancer (Phase I)
- Bladder Cancer (Phase II)
- Hematological Cancer (Phase I)
- Lymphoma (Phase I)
Immunology
- Chronic graft-versus-host disease (Phase II)
Obstetrics/Gynecology
- Vaginitis (Phase IV)
Systems Experience
Veeva Unified Clinical Vault (UCV): 9 years of experience
Siebel Clinical Trial Management System (CTMS): 3 years of experience
OnCore Clinical Trial Management System (CTMS): 5 years of experience
Xcellerate Risk Management Suite: 5 years of experience
Site Agreements Management System (SAMS): 3 years of experience
Advarra IRB Center for IRB Intelligence (CIRBI): 9 years of experience
WCG IRB Connexus: 9 years of experience
Medidata Rave Electronic Data Capture (EDC): 6 years of experience
InForm Electronic Data Capture (EDC): 5 years of experience
Medrio Electronic Data Capture (EDC): 5 years of experience
Suvoda IRT: 1 year of experience
SPEED Portal: 1 year of experience
Affiliations
- The Society of Clinical Research Associates, Inc. (SOCRA) Member
- Ochsner Institutional Review Board (IRB), Alternate Panel Member
Certification
International Council for Harmonization Good Clinical Practice (ICH GCP), Fortrea, 2025
Languages
English - ILR 5 (Native or Bilingual)
Timeline
Project Manager, Start-up
Fortrea Inc (Formerly LabCorp)
06.2025 - 07.2026Read More
Associate Project Manager II, Start-up
Fortrea Inc (Formerly LabCorp)
03.2023 - 06.2025Read More
Clinical Trial Manager III
Fortrea Inc (Formerly LabCorp)
12.2021 - CurrentRead More
Centralized Start Up Lead
Fortrea Inc (Formerly LabCorp)
12.2021 - 03.2023Read More
Clinical Research Regulatory Specialist
Ochsner Health
11.2019 - 12.2021Read More
Associate Clinical Research Coordinator
Ochsner Health
04.2018 - 11.2019Read More
Data Coordinator
Ochsner Health
02.2017 - 04.2018Read More
Engineering Technician 4
Louisiana Department of Transportation
12.2016 - 02.2017Read More
Graduate Teaching Assistant
University of New Orleans
01.2016 - 12.2016Read More
Louisiana State University
Bachelor of Science (BS) from Physics
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