Professional Summary
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.
Skilled in managing multiple concurrent workstreams, supporting implementation activities, driving stakeholder alignment, resolving operational issues, and creating scalable processes, documentation, and training materials. Experienced partnering with product, technology/engineering, clinical, QA, regulatory, and vendors to improve delivery, support client/partner needs, and ensure high-quality execution.
I am known for being detail-oriented, proactive, and highly collaborative, with a strong ability to mentor and motivate teams, manage stakeholder expectations, and drive projects forward. I bring a strong combination of project management and healthcare technology experience, thriving in roles where I can support SaaS operations, partner success, and process optimization.
Experience
Quality Specialist
- Identify recurring quality issues and evaluate linguist performance, including machine translation errors, reviewer/translator quality gaps, and document findings to improve overall translation quality.
- Review clinical trial materials to ensure linguistic accuracy, clarity, and consistency in alignment with clinical and regulatory standards.
Client & Communications Liaison
- Led cross-functional workstreams involving families, school administrators, educators, and external service providers to align timelines and ensure coordinated service delivery.
- Navigated sensitive and complex situations, ensuring compliance with policies and maintaining clear, consistent communication across stakeholders.
Senior Project Manager
- Led a team of 12 translation managers, resolving client escalations and improving overall customer satisfaction.
- Mentored 3 project managers/localization professionals, providing performance feedback and quality oversight to ensure high-quality deliverables.
- Designed and implemented SOPs, playbooks, documentation, and training materials to support scalable team execution and improve efficiency.
- Owned delivery workflows, quality standards, and vendor coordination, resolving integration issues to ensure on-time execution.
- Served as an SME in translation workflow and as a primary point of contact for internal/external stakeholders across healthcare SaaS delivery workstreams.
Project Manager
- Selected as senior lead across three service lines (respiratory, eCOA, and cardiac safety), streamlining processes and reducing delivery timelines.
- Managed end-to-end delivery of multilingual clinical trial content within GxP-regulated environments, partnering with cross-functional teams.
- Defined project scope, timelines, and delivery requirements in collaboration with sales and cross-functional teams to support client governance.
Branch Manager & English Program Lead
- Managed day-to-day branch operations and led cross-functional teams in a fast-paced, client-facing environment.
- Led a team of 15+ instructors and administrative staff to ensure consistent delivery of programs and services, strengthening client retention.
Project Manager
- Established the respiratory translation function by designing SOPs, workflows, and training materials, improving deliverable quality by 45%.
- Established and led localization operations supporting global clinical trials in GxP-regulated environments, driving process standardization.
- Managed multilingual delivery of patient- and site-facing clinical trial content, ensuring accuracy and compliance in regulated environments.
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