About Carla
Carla Heuer is a clinical technology professional with 10+ years of experience across regulated clinical trials, healthcare SaaS, quality, localization, and global delivery. Her career combines hands-on quality work with project leadership, process development, stakeholder management, and cross-functional collaboration.
Her experience spans patient-facing clinical technology, eCOA/COA, multilingual delivery, software testing and validation, SOP development, team leadership, and work with Product, Engineering, QA, Regulatory, clients, and vendors.
Choose a focus to view the parts of Carla's experience most relevant to that type of role.
Professional Profile
Carla's background sits at the intersection of clinical technology, quality, and project delivery. Select a focus above to see a role-specific professional summary, experience highlights, and core competencies.
I am a senior healthcare operations and project management professional with 10+ years of experience leading cross-functional initiatives across regulated clinical trial, healthcare technology, and client-facing environments.
I manage concurrent workstreams, implementation activities, stakeholders, vendors, timelines, risks, resources, and delivery requirements. I have partnered with Product, Engineering, QA, Regulatory, clinical teams, clients, and vendors to resolve issues, improve processes, and deliver high-quality work in regulated environments.
I am a clinical technology and quality professional with hands-on experience testing patient-facing software and eCOA applications in regulated clinical trial environments. My work has included functional, regression, validation, and acceptance testing against defined requirements.
I have tested web, iOS, Android, BYOD, and simulated environments; identified and documented defects; worked with Engineering and QA on corrections; retested fixes; and supported release readiness. I also develop and improve SOPs, testing procedures, checklists, and work instructions, and use AI tools to support test scenarios, quality reviews, documentation, and issue analysis with human verification.
Experience
Select Project Management or Quality & Software QA above to view role-specific experience.
Quality Specialist
- Review clinical trial materials for linguistic accuracy, clarity, consistency, and alignment with clinical and regulatory standards.
- Identify recurring quality issues, evaluate vendor performance, and document findings that contribute to improved delivery quality.
Client & Communications Liaison
- Led cross-functional workstreams involving families, administrators, educators, and external service providers while managing timelines, documentation, and service delivery.
- Built relationships with 400+ families and staff in a compliance-driven, cross-cultural environment.
Senior Project Manager
- Managed localization professionals and concurrent clinical technology workstreams, providing mentoring, performance feedback, and quality oversight.
- Drove initiatives across Product, Engineering, QA, and Regulatory teams by aligning requirements, dependencies, timelines, and workflow needs.
- Designed and implemented SOPs, playbooks, documentation, and training materials to standardize workflows and reduce turnaround times.
- Owned delivery from requirements and planning through execution, issue resolution, quality review, and final delivery across studies with 30+ locales.
Project Manager
- Owned multilingual clinical trial projects from initiation through final delivery, managing scope, timelines, risks, dependencies, client expectations, and cross-functional coordination.
- Led translation and validation workstreams supporting cardiac safety, eCOA/COA, and respiratory programs while maintaining compliance and data integrity.
- Selected as lead across three service lines, improving processes and reducing delivery timelines.
Branch Manager & English Program Lead
- Managed branch operations and led a team of 15+ instructors and administrative staff.
- Coordinated schedules, services, client relationships, and team development in a fast-paced environment.
Project Manager
- Established the respiratory translation function and developed operational procedures, manuals, and guides, improving deliverable quality by 45%.
- Managed multilingual delivery of patient- and site-facing clinical trial content in regulated environments.
- Trained team members and coordinated workflows, timelines, and quality expectations.
Quality Specialist
- Perform detailed quality review of clinical trial content, identifying linguistic, machine-translation, reviewer, and vendor quality issues.
- Document recurring findings, challenge discrepancies, and work with project and technical teams to correct issues before final delivery.
- Review patient-facing content for accuracy, consistency, clarity, and compliance with defined clinical and regulatory requirements.
Senior Project Manager | Quality & Software Testing Responsibilities
- Performed hands-on functional, regression, validation, and acceptance testing of patient-facing clinical technology and eCOA applications against defined requirements.
- Tested web, iOS, Android, BYOD, virtual/simulated environments, and multilingual configurations for screen behavior, navigation, questionnaires, scrolling, formatting, content, and localization accuracy.
- Identified and documented software defects in Jira/GitLab, collaborated with Engineering and QA to clarify issues, tracked corrections, and retested fixes before acceptance.
- Compared updated functionality with prior versions to identify regressions and verify that new changes did not adversely affect previously working content or workflows.
- Reviewed testing performed by others, identified missed discrepancies, and escalated functionality that did not meet requirements or was not ready to proceed.
- Created and improved SOPs, testing procedures, checklists, work instructions, and playbooks as systems, tools, and processes changed.
- Used generative AI tools including ChatGPT and Copilot to support test scenarios, checklists, documentation, issue summaries, and quality review, with human verification of outputs.
Project Manager | Quality & Validation Responsibilities
- Tested clinical technology and eCOA/COA screens against requirements, source content, language specifications, and expected behavior before study delivery.
- Performed requirements-based review and validation of patient-facing screens, including wording, layout, navigation, questionnaires, screen fit, and multilingual content.
- Documented issues, coordinated corrections with technical teams, and retested updated functionality to verify resolution.
- Supported quality-controlled delivery and release readiness across respiratory, eCOA, and cardiac safety service lines while maintaining data integrity and regulatory compliance.
Project Manager | Quality Process Development
- Built procedures, manuals, guides, and quality workflows for the respiratory translation function, contributing to a 45% improvement in deliverable quality.
- Reviewed multilingual patient- and site-facing clinical trial content for accuracy and compliance and trained team members on standardized quality processes.
Education & Volunteering
Florida International University
Graduated Cum Laude with a GPA of 3.58.
Fundacao Joao Pinheiro
Focus on Budgeting, Healthcare Administration, and Nonprofit Management.
Best Buddies International
Provided one-to-one friendship, support, and companionship to adults with intellectual and developmental disabilities.
Core Competencies
Certifications
- 21 CFR Part 11 (Code of Federal Regulations)
- Medical Devices Consultant according to 31 MPG
- Construction Management Certificate
- Cambridge Advanced English Certificate (CAE)
- First Cambridge English Certificate (FCE)
Languages
- English: Native / Bilingual
- Portuguese: Native / Bilingual
- Spanish: Native / Bilingual
- German: Limited Working Proficiency
Contact Information
- Email: CarlaCHeuer@gmail.com
- Phone: (267) 699-8821 (Mobile)
- Location: South Carolina (Eastern US)
- LinkedIn: linkedin.com/in/carlacheuer