Clinical Study Manager

Lance Ehrold
Sarmiento

Clinical Database Architect  ·  Trial Master File Lead  ·  Clinical UX & Product Liaison
🚀 Start-up Operator 🌏 Trials: US & Canada · Teams: Vietnam & Philippines ✦ Applied AI in Clinical Research
01

About

Lance Ehrold Sarmiento
Phase I–IV EDC TMF GCP Start-up
🗄Clinical Database Architect
📋Trial Master File Lead
🛠Clinical UX & Product Liaison
🚀
As a key team member at Talosix, Lance operates as a true generalist — simultaneously owning Clinical Study Management, Data Management, TMF, Finance Oversight, Quality, and Product UX across multiple live trials. Comfortable working across cultures and time zones, collaborating daily with colleagues and stakeholders spanning the US, Canada, Philippines, and beyond — because great clinical research doesn't stop at borders.

Clinical Project Manager with extensive experience across Phase I–IV clinical trials, research management in drug discovery, and pre-clinical studies. Clinical trial operations span the U.S. and Canada, while cross-functional collaboration extends to engineering teams in Vietnam and operations in the Philippines.

As clinical UX representative, works directly with Talosix’s engineering team to shape EDC and database development — translating real-world trial requirements into product features aligned with industry standards. Combines rigorous GCP knowledge with hands-on AI-enabled clinical tool development in one of the industry's most innovative established clinical technology platforms.

Clinical Trial Operations
🇺🇸
United States
🇨🇦
Canada
Cross-functional Teams
🇻🇳
Vietnam · Engineering
🇵🇭
Philippines · Operations
4+
Years Clinical Research
US & CA
Clinical Trial Markets
I–IV
Trial Phases
7+
Roles Held at Once
02

Experience

Feb 2024 — Present · 2 Years
Talosix · Seattle, WA  ·  Growth-Stage Company
Clinical Study Manager
Clinical Database Architect Trial Master File Lead Clinical UX & Product Liaison
Healthcare technology company specializing in clinical research solutions and a proprietary EDC platform. As an early team member of a now growth-stage company, Lance operates across seven functional areas simultaneously — a hallmark of high-impact start-up contribution.
🩺 Clinical Ops 📊 Data Management 🛠 Product / UX 💰 Finance ✅ Quality & Compliance
  • Clinical Operations: Managed Phase I–IV trial execution across the US and Canada — including site activation, monitoring support, CRA training, and regulatory documentation — spanning therapeutic areas such as Oncology, Investigational Product (IP) trials, and Orthopaedic Registry studies
  • Client Management: Primary sponsor and CRO contact for contract coordination, scope alignment, and study kick-offs — managing relationships across Oncology, IP, and Registry trial portfolios in the US and Canada
  • Data Management: Led eCRF design and database build for Oncology, IP, and Registry protocols — developing data validation scripts, edit check logic, and data review plans tailored to protocol-specific endpoints, adverse event reporting, and regulatory submission requirements
  • TMF Lead/Owner: Owned and maintained the Trial Master File across concurrent Oncology, IP, and Orthopaedic Registry studies using Kivo — ensuring inspection-readiness, QC compliance, and completeness metrics aligned with ICH E6(R2) and TMF Reference Model standards
  • Quality & Compliance: Developed SOPs, validation plans, and training materials ensuring GCP and 21 CFR Part 11 compliance
  • Finance Management: Managed project financials, site reimbursement verification, and payment tracking
  • Product Management / UX: Served as clinical UX representative for AI-enabled tool development — including an Endpoint Adjudication module for Oncology outcomes, automated MedDRA/WHODrug medical coding for IP adverse event management, and a remote trial inventory system supporting multi-site IP accountability
Kivo TMFeCRF DesignGCP / 21 CFR Part 11 MedDRA / WHODrugEpic · Medidata Rave · Oracle Clinical AI Tools UXPhase I–IVCross-functional Leadership Investigational Product (IP) TrialsOncologyOrtho Registry
Jul 2022 — Jul 2023 · 1 Year 1 Month
Philippine Council for Health Research and Development (PCHRD) · DOST
Senior Project Manager
End-to-end management of government-funded projects spanning drug discovery, pre-clinical trials, and emerging disease programs — coordinating with international health bodies and multi-country stakeholders.
  • Primary liaison for WHO, NICT Tokyo, EU-Greentech Initiative, e-ASIA Joint Research Program, Baylor College of Medicine, and the Department of Health
  • Oversaw ICT health application projects including ML, automation, database architecture, and web/mobile app deployment for Local Government Units
  • Played a key strategic role in planning the Virology and Vaccine Institute of the Philippines (VIP)
  • Drafted technical position papers, policy briefs, and media statements for high-level government and international audiences
WHOInternational PartnershipsPolicy & AdvocacyPre-clinical Research
Feb 2023 — Jun 2023 · 5 Months
Technology Application and Promotion Institute (TAPI) · DOST
Project Management Consultant
Supported technology commercialization initiatives and inventor assistance programs within the national science and technology agency.
Technology TransferInnovation ProgramsGovernment Consulting
May 2021 — Jun 2022 · 1 Year 2 Months
PCHRD · Department of Science and Technology (DOST)
Junior Project Manager
Coordinated national health research programs under DOST — supporting project monitoring, reporting, and stakeholder coordination across government-funded health research initiatives.
Health Research CoordinationGovernment ProgramsProject MonitoringStakeholder Management
Feb 2020 — Jul 2020 · 6 Months
University of the Philippines Manila · Biological Models Laboratory
Laboratory Analyst
Drug discovery laboratory specializing in the utilization of C. elegans to identify potential therapeutic compounds and study disease mechanisms from Philippine natural products.
Drug DiscoveryC. elegans ModelsPre-clinical StudiesNatural Products Research
03

Applied AI in Clinical Research

Lance actively integrates emerging AI tools into day-to-day clinical operations — not as a technology experimenter, but as a practitioner who understands the regulatory, quality, and operational boundaries of the clinical research environment. These applied capabilities translate directly into faster execution, stronger documentation, and sharper decision-making across live trials.

📋
Clinical Document Drafting & QC
Applies AI to accelerate first-draft generation of SOPs, Data Management Plans, Monitoring Plans, and TMF index documentation — then reviews and validates against protocol and regulatory requirements.
SOPs DMP TMF Docs Monitoring Plans
🔍
Protocol Analysis & Query Resolution
Uses AI to cross-reference protocol requirements against CRF data patterns, supporting faster query identification, edit check logic development, and discrepancy resolution during data cleaning cycles.
Edit Check Logic Query Management Data Cleaning
🌐
Cross-cultural Stakeholder Communications
Leverages AI to adapt technical communications for sponsors, CROs, and site teams across US, Canada, Vietnam, and the Philippines — ensuring clarity, cultural fit, and the right level of regulatory precision for each audience.
Sponsor Updates Site Communications Meeting Summaries
🛠
Product UX & Requirements Support
As clinical UX representative for Talosix's AI-enabled modules, uses AI to synthesize user feedback, draft feature requirements, and develop user acceptance criteria for Endpoint Adjudication and automated medical coding tools.
User Stories UAT Criteria Feature Requirements
⚙️
Operational Workflow Optimization
Applies AI to compress multi-step operational tasks — automatic meeting note summarization, action item extraction, status report generation, and project tracking updates — enabling faster turnaround in a lean start-up team.
Meeting Notes Status Reports Action Items
📚
Regulatory & GCP Research
Uses AI to efficiently research and summarize applicable GCP, FDA, ICH, and HIPAA guidance — quickly identifying compliance considerations relevant to active trial protocols, EDC configurations, and evolving regulatory landscapes.
GCP Guidance ICH Guidelines HIPAA FDA Regulations
03

My Clinical Research Journey

Clinical Technology · Seattle, WA Growth-Stage

Talosix builds proprietary clinical trial technology — including a purpose-built EDC platform, AI-enabled data review modules, and end-to-end trial management infrastructure — for CROs and sponsors running complex, multi-site studies. The company operates at the intersection of clinical science and enterprise software, with a product built by clinicians, for clinicians.

My Role Clinical Study Manager + Database Architect · TMF Lead · Clinical UX & Product Liaison

As one of the early team members, I wear multiple hats simultaneously — spanning clinical operations, EDC architecture, regulatory compliance, product UX representation, and client management across Phase I–IV oncology, investigational product, and orthopaedic registry studies in the US and Canada.

EDC / eCRFPhase I–IVAI-Enabled Tools Clinical OpsTMF21 CFR Part 11
Government Research Agency · Philippines Dept. of Science & Technology

The Philippine Council for Health Research and Development (PCHRD) is the Philippine government's primary funding and coordinating body for health research. Under DOST, PCHRD manages national research programs spanning drug discovery, pre-clinical studies, infectious disease, and health systems — coordinating with WHO, international research bodies, and the Philippine Department of Health.

My Roles Senior PM & Junior PM 2021 – 2023 · 2 Years · Promoted within organisation

Progressed from Junior PM to Senior PM — managing government-funded health research programs end-to-end, from budget oversight and stakeholder coordination to international partnerships with WHO, Baylor College of Medicine, and the EU-Greentech Initiative. Played a strategic role in planning the Virology and Vaccine Institute of the Philippines (VIP).

Drug DiscoveryPre-clinical Research WHO PartnershipPolicy BriefsInternational Coordination
State University · Manila, Philippines Founding Institution

The University of the Philippines Manila is the country's premier health science university and one of the oldest research institutions in Southeast Asia. Its Biological Models Laboratory conducts pre-clinical drug discovery research — leveraging C. elegans as a biological model to identify therapeutic compounds from Philippine natural products.

My Role Laboratory Analyst Feb 2020 – Jul 2020 · 6 Months · Short-term Research Engagement

Contributed to pre-clinical drug discovery using C. elegans biological models — screening Philippine natural product compounds for therapeutic potential. This early research experience bridged bench science with eventual work in Phase I–IV trial operations.

C. elegans ModelsDrug Discovery Natural ProductsPre-clinical Studies
Private University · Manila, Philippines Alma Mater · Est. 1611

The University of Santo Tomas is the oldest existing university in Asia, founded in 1611. Its Faculty of Pharmacy and College of Science are long-standing centres of excellence in biochemistry and health research — producing graduates who lead in clinical research, pharmaceutical development, and public health across the Philippines and globally.

Degree B.S. Biochemistry Graduated 2019 · Faculty of Pharmacy

Undergraduate thesis applied computational chemistry to drug discovery — using Python scripting, iGEMDOCK, ClusPro, and AutoDock Vina for molecular docking, Modeller for protein homology modelling, and NAMD for molecular dynamics simulations across Windows and Linux environments. This formed the computational backbone connecting to wet-lab work at UP Manila and ultimately to clinical trial data management.

Computational ChemistryMolecular Docking AutoDock VinaiGEMDOCK · ClusPro Protein Modelling (Modeller)Molecular Dynamics (NAMD)Python · Linux
04

Skills

Clinical Operations
Clinical Trial Management (Phase I–IV)95%
EDC Systems & eCRF Design92%
TMF Management (Kivo)90%
GCP & Regulatory Compliance93%
MedDRA / WHODrug Medical Coding85%
Data Validation & Query Management88%
EDC Platforms — Epic · Rave · Oracle85%
Leadership & Strategy
Multi-functional Start-up Operations93%
Cross-cultural Stakeholder Management92%
Agile Project Management85%
Clinical Product UX (AI Tools)82%
Applied AI in Clinical Operations80%
International Research Collaboration88%
Tools & Platforms
KivoMonday.com Epic EHRMedidata RaveOracle Clinical EDC PlatformsHIPAA Compliance ICH Guidelines21 CFR Part 11 Microsoft OfficeAgile / Scrum AI-Assisted WorkflowsClinical Data Management SOPs & ValidationSite Management
05

Education

Bachelor of Science in Biochemistry
University of Santo Tomas, Sampaloc, Manila
June 2019
Strong foundation in biological sciences, chemical analysis, and laboratory research — underpinning a career in clinical trial science and drug development operations.
Continuous Professional Development
Anthropic · Google · Coursera · University of Minnesota · NIDA · HIPAATraining
2017 — Present
14+ professional certifications spanning GCP, HIPAA, AI Fluency, Claude Skills, Agile, Project Management, TMF Standards, Negotiation, and international health research.
06

Certifications

Certificate of Completion: Claude 101
Anthropic
Mar 2026 · Credential ID pfeh6kzu2juq
Claude Skills
AI Fluency Framework & Foundations
Anthropic
Mar 2026 · Credential ID 8v7hvvtbr9xb
AI Fluency
Negotiation Foundations
LinkedIn
Feb 2026
Negotiation
HIPAA Security
HIPAATraining.com · Talosix
Issued Dec 05, 2025 · Expires Dec 05, 2027
Clinical Study Management
HIPAA Awareness for Business Associates
HIPAATraining.com · Talosix
Issued Dec 05, 2025 · Expires Dec 05, 2027
Clinical Study Management
TMF Standard Model V1
Kivo
Dec 2025
Good Clinical Practice (GCP)
NIDA Clinical Trials Network
Feb 2024
Project Management with Monday.com
LinkedIn Learning
Feb 2024
Project Management Specialization
Google / Coursera
Jun 2023
Agile Software Management
University of Minnesota
May 2023
World One Health Congress 2022
Temasek Foundation
Nov 2022
AMR Innovation Mission UK 2021
AMR Insights
May 2021
07

Awards

🏆
Champion — Young Scientists Forum 2019
46th Philippine Society of Biochemistry and Molecular Biology Annual Conference
November 2019
Co-author — "Cholinergic, beta-secretase, and oxidative activity evaluation of spider venom from Philippine Tarantula (Therposidae)"
🎖️
Gawad Pananaliksik (Research Excellence Award)
University of Santo Tomas
March 2019
Best Operations Committee Member
Philippine Association of Chemistry Students
March 2018
Get in Touch

Let's work together

Open to clinical research leadership roles, start-up clinical operations, and multinational trial management opportunities.

P.S.
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