Daniela González

I am a versatile Senior Project and Program Manager with over a decade of multi-industry experience spanning life sciences, pharmaceuticals, medical devices, mental health, legal, media production, and aviation/travel digital content. My career is defined by my ability to operate across distinct project management paradigms—ranging from highly regulated, audit-ready clinical governance programs to commercially driven, AI-automated localization and digital content operations.

Depending on organizational needs, I scale my expertise across multiple domains: leading cross-functional tech teams, driving account management and client retention, optimizing global vendor networks, and engineering AI-driven process transformations. I thrive at the intersection of operational excellence and technological innovation, consistently delivering measurable bottom-line growth, such as increasing gross profit margins from 50% to 70%. I am looking to bring this adaptable, multi-faceted project leadership to your organization.

Clinical Governance & Regulatory Program Management: Acting as the primary operational lead across the life sciences, medical device, pharmaceutical, healthcare, and mental health sectors, this function focuses on strict compliance-driven execution and audit readiness within validated Quality Management Systems (QMS).

Responsibilities include managing the complete, audit-ready lifecycle of safety-critical clinical documentation—such as Clinical Trial Protocols, Informed Consent Forms (ICFs), Patient Information Leaflets, pharmacovigilance reports, and Instructions for Use (IFUs)—while ensuring 100% adherence to international frameworks like ICH-GCP, ISO 13485, GxP, and FDA/EMA regulations. Key achievements include successfully steering global programs through numerous internal and external audits, including FDA (21 CFR Part 820) and MDR/IVDR submissions, and executing ISO 14971-aligned clinical risk management across multi-market trial environments to completely eliminate content non-conformances. Furthermore, this role strategically deployed AI and LLM-assisted workflows within validated clinical environments, successfully lowering quality assurance latency without compromising clinical data integrity or patient safety.

Commercial Operations, Team & Vendor Management: Centered on scaling end-to-end operational framework success, this paradigm covers large-scale project and program delivery, resource allocation, and team leadership across global translation, localization, and freelance environments, including over a decade of executing versatile, high-volume project lifecycles on Upwork.

Key responsibilities involve translating strategic goals into scalable, repeatable operational workflows, directing and mentoring cross-functional project teams, establishing standardized production pipelines, and managing extensive global vendor networks to support fluctuating market demands. Operational discipline is maintained through strict budget adherence, cost-containment strategies, rigorous KPI tracking, and compliance with strict SLAs and ISO standards. A major achievement under this framework includes driving continuous process optimization by implementing new workflows, AI-enabled Translation Management Systems (TMS), and complex business suites, which directly resulted in increasing the average team gross profit margin from 50% to 70% in a single year.

Leadership, People Development & Team Training: Built on a foundation of professional cultivation and organizational excellence, this functional profile highlights a proven track record of mentoring talent and managing high-performing teams, including directly leading teams of up to six project managers.

Responsibilities encompass managing global recruitment pipelines, overseeing end-to-end onboarding, evaluating employee performance milestones, and engineering targeted employee performance audits to isolate operational gaps. This methodology relies heavily on executing data-driven Corrective and Preventive Actions (CAPA) and constructing specialized re-training plans. Key achievements include acting as the primary technology implementation lead—spearheading the rollout, tool integration, and comprehensive staff training for industry-standard platforms including Asana, Zoho CRM, HubSpot CRM, Smartcat, RWS Trados Studio, Plunet Business Manager, Jira, Confluence, Monday.com, Trello, Podio, and memoQ—while regularly hosting industry-facing localization webinars and presentations to share operational best practices.

Client Services, Account Management & Business Development: Operating at the front lines of business-to-business professional services, this functional profile balances day-to-day project execution with high-stakes account governance and commercial growth across diverse global markets.

Responsibilities include serving as the primary client point of contact for enterprise-level accounts, managing the entire lifecycle of client satisfaction from onboarding and kick-off calls to comprehensive KPI reporting, financial invoicing, conflict resolution, and SLA monitoring. This position acts as a critical escalation hub for complex account issues, coordinates cross-departmental alignment during client reviews, and directly supports global procurement by driving response efforts for high-value RFI/RFP processes. Achievements center on defining and executing long-term account initiatives that safeguard client retention, resolve intricate escalations, protect business profitability, and represent client interests during high-level executive and cross-functional business reviews (ABRs and QBRs).

Digital Content Strategy & Media Production Project Management: This paradigm drives end-to-end creative workflows, multimedia localization, and data-driven marketing execution across the digital marketing, media production, IT, and aviation/travel tech industries. Core responsibilities include spearheading the production, creative writing, transcreation, and global adaptation of digital-first assets, managing cross-functional teams of creators, copywriters, and multimedia professionals, and maintaining strict global brand voice consistency across multiple geographical targets. This framework relies heavily on data-driven marketing insights, utilizing keyword gap analysis, search intent mapping, taxonomy development, on-page optimization, H-tag hierarchy, and semantic content clustering to refine localized assets.

Key achievements include successfully scaling organic search engine visibility, managing complex travel-industry content localization platforms, and dramatically raising localized search rankings across diverse international growth markets.

Specialized Linguistic Engineering & Subject-Matter Project Support: Rooted in high-precision execution across the psychopharmacology, psychiatry, healthcare, legal, technical, and finance sectors, this framework covers the lifecycle of highly technical human translation, review, editing, proofreading, and transcreation.

Responsibilities involve acting as a critical subject-matter expert, synthesizing complex scientific articles, psychiatric protocols, and intricate legal/financial documentation requiring strict terminology management and native linguistic precision in both Spanish and English. This role ensures absolute cultural adaptation, UX linguistic testing, Machine Translation Post-Editing (MTPE), and MT Quality Estimation while aligning output with foundational digital content standards like E-E-A-T (Experience, Expertise, Authoritativeness, Trustworthiness) and YMYL (Your Money or Your Life). Key achievements include building specialized linguistic quality assurance (LQA) profiles, creating comprehensive style guides and translation memories, and adapting advanced pharmacological mechanisms so they remain authoritative for international medical professionals and researchers.

Bachelor of Science in Biology | Instituto San Pedro Nolasco (Graduated 2015)

Medical Biller and Coder Certification | Middlesex County College (Graduated 2008)

Scientific and Literary Translator Degree | Instituto de Lenguas Vivas (In Progress / Candidate)

PMP® (Project Management Professional) | Project Management Institute (In Progress / Candidate)

Localization Engineer Certification | Localization Academy (Completed 2024)

AI Prompt Engineering Certificate & AI in Localization Coursework (Completed 2025)

Technical & Systems Skills: Advanced scripting in PowerShell and Claude/Claw for AI pipelines; hands-on expertise in optimizing workflows using Google Gemini, Microsoft Copilot, and over 25 enterprise CRM, CMS, and TMS tools (such as Plunet, SinglePoint, Phrase, and Smartling).