Caroline Flessa, MPH | Clinical Data & Governance Leader

0+
Years across clinical and adjacent research: <0 mo
To novel internal wearable QC framework: 0%
On-time SAS exports at Clario: 0+
Concurrent global eCOA implementations

I run an independent clinical data practice focused on digital health technology governance, wearable and sensor data, and eCOA operations. Previously Associate Director of Data Operations at Pfizer's Digital Sciences team, where I directed the design and build of a novel internal QC and governance framework for wearable sensor data, built from the ground up with no existing vendor model to follow.

Before Pfizer, I managed eCOA data operations at scale across global clinical portfolios: 15+ concurrent studies at Clario, including multiple Phase III oncology trials, and 10+ concurrent global implementations at Kayentis, where I was the sole US-based CDM responsible for study start-up. My work spans the full data lifecycle: study start-up, specifications, database lock, and analysis-ready delivery.

I hold an MPH from Boston University and work across Python, SAS, SQL, and clinical data platforms including Veeva CDMS and Veeva CDB. Therapeutic areas span oncology, CNS, dermatology, rheumatology, immunology, respiratory, and reproductive endocrinology. Much of my work comes down to making complex data usable for the people who act on it: I've written documentation suites for regulatory audiences, co-authored scientific abstracts and poster materials, and translated between data science, biostatistics, and operations teams. I'm actively looking for a senior individual contributor or lead role in clinical data management, digital health, data operations, or medical communications, whether in pharma, biotech, research, nonprofit, or adjacent sectors.

OncologyDermatologyRheumatologyImmunologyRespiratoryReproductive EndocrinologyCNS

Career Path

Founder, Clinical Data & Governance Consultant · Bridgid Advisory

May 2025–Present

After Pfizer, went deeper on the technical side and built an independent practice at the intersection of clinical data and digital health technology. Advised an early-stage digital health company on data governance strategy, EDC selection, and regulatory-aligned standards for clinical and sensor data, delivering a vendor comparison and compliance framework that informed the CSO's platform decision. Completed targeted certifications in clinical data governance, clinical trials operations, data science, and AI tooling. Built applied tools including regulatory AI and biofeedback prototypes.

Clinical Data ConsultingData GovernanceEDC SelectionPythonAI/ML21 CFR Part 11

Education & Certifications

MPH, Epidemiology & Biostatistics
Boston University School of Public Health
BA, Psychology, Cum Laude
Framingham State University
Clinical Trials Operations Specialization, Johns Hopkins (2026) | ICH GCP, TransCelerate & ICON (2025) | Veeva Vault CDMS & CDB | REDCap Cloud
Clinical Operations & Compliance
Databricks (Generative AI, AI Agents, Data Engineering) | Neo4j | Anthropic Model Context Protocol (2026)
AI & Data Engineering
Responsible AI Governance, 5-course series, All Tech Is Human | Ethical Data Handling, Fred Hutch (2026)
Responsible AI & Data Governance
Genentech Data Sciences in Pharma (Real-World Data, Patient-Centered Outcomes, HTA) | Making Data Science Work for Clinical Reporting, Genentech (2026) | ML in Healthcare, Cleveland Clinic | PySpark, Biopython, RAG (2026)
Data Science in Pharma & Health
Foundations of Agile Project Management, Google (2026)
Project Management

Community

Women Applying AI (WAAI): Web Content Manager (2026)
Healthcare Businesswomen's Association (HBA): Connector (2026); Mentee (2025); presented on Executive Presence to cohort and distributed supporting materials as part of HBA New England Mentor Program (2026)

Endorsements

“Caroline consistently exemplified leadership qualities by providing guidance to colleagues and fostering a cohesive work environment. Her meticulous attention to detail and analytical acumen ensured the integrity and precision of every deliverable, reflecting her unwavering dedication to excellence.”

Karnaditya Rana, MBA, MPHAssociate Director, Clinical Data Management · Multi-omics, Precision Medicine & Cancer Gene Therapy

“After completing her project with us, Caroline continued to work with Kupenda as a pro-bono consultant for an additional year, working closely with both our US developers and Kenyan app users to further refine and scale the app. She demonstrated leadership throughout and was consistent in meeting every deliverable and deadline.”

Jessica AbramsDevelopment Director · Kupenda for the Children

Let's Connect

Open to full-time clinical data and data operations roles. If you're building a team that works with digital measures or sensor data, let's talk.

Get in touch →cmflessa@proton.me

Design for reuse from the start

Modular code, standardized specs, and documentation built to last, so a QC framework or data system can be picked up and applied across studies, not rebuilt each time.

Document for the auditor

Every workflow I build is structured for regulatory and internal governance from day one: validation logs, dataflow maps, and inspection readiness built in, not added at the end.

Work across the aisle

I've worked directly with data science, biostatistics, and clinical operations teams to turn ambiguous requirements into shared technical specs, and to keep data decisions traceable back to a clinical rationale.

Know the tooling, know its limits

I actively pursue Python, Databricks, and AI coursework so the data practices I recommend reflect where the field is going, and so I can tell the difference between a useful tool and an unvalidated one.

Selected Work · tap a row to expand

Challenge

No reusable framework existed for QC of continuous wearable sensor data across a pharma portfolio.

Approach

Directed the design and build as the accountable Data Operations lead, independently delivering five deliverable categories: standardized data definitions, modular Python QC code, a quality metrics framework and specifications, validation logs, dataflow maps, and project timelines. Master technical QC requirements co-developed with the internal data science team.

Outcome

Full framework delivered in under six months and ready for testing on formal handover. Governance included dual-reviewer sign-off across QC checkpoints, a cross-study metrics database for reporting, and a full documentation suite structured for audit.

Challenge

A high-visibility global portfolio needed eCOA implementations stood up across 10+ concurrent studies, with one US-based CDM available to lead.

Approach

Led study start-up as the sole US-based CDM, authoring data management plans and edit-check specs, and collaborating with sponsor and CRO partners on CDISC/SDTM-aligned data transfer and mapping specifications. Retained post-handover as subject-matter expert on protocol amendment impacts.

Outcome

Delivered start-up across 10+ concurrent global studies, maintained as the go-to SME on amendment and data transfer implications, and trained and mentored 3–5 monitoring data managers through a period of significant departmental restructuring.

Challenge

15+ concurrent global studies, including multiple Phase III oncology trials with thousands of randomized subjects, required eCOA data management from setup through database lock with no margin for export delays.

Approach

Owned eCOA data management across the full portfolio, with solid-tumor oncology indications among the largest studies. Refined instrument and export configurations to protect data accuracy and runtime performance at scale.

Outcome

Delivered 100% on-time, analysis-ready SAS exports across 15+ concurrent global studies and received the Endeavor Award for sustained client impact.

Challenge

A digital health startup needed to choose an EDC platform and establish regulatory-aligned governance for sensor and outcome data.

Approach

Advised on data strategy and EDC platform selection, assessing options against regulatory requirements for sensor and outcome data governance.

Outcome

Delivered a regulatory-informed vendor comparison and integration roadmap to the CSO and team within the first month of the engagement.

Challenge

Kupenda needed a scalable digital tool to track and support children with disabilities and their families across Kilifi County, Kenya, with no dedicated technical staff to lead the build.

Approach

Contributed pro-bono consulting as part of a BUSPH team, working in partnership with Kupenda's US and Kenya-based staff to design and build the CommCare child case management app, aligning features with organizational workflows and community needs. Extended the engagement a full year post-coursework to collaborate on refinement and scale. Generated and validated custom SAS code to analyze piloted app data in-house.

Outcome

App launched and deployed in Kilifi County, enabling Kupenda staff to screen and support hundreds of families in its first months of operation and identify families in crisis at scale.

Data Science & Analytics

PythonReproducible WorkflowsDataset PrepLongitudinal & Observational DataData Summaries & VisualizationDatabricksSASSQL

Digital Measures & Endpoints

Wearable & Sensor Data QCDigital BiomarkersMeasurement Validation (reliability, validity)eCOA / ePROEndpoint Data Documentation

Data Quality & Governance

Data Governance & QCValidation Logic & SpecsRBQMAudit & Inspection ReadinessUAT

Standards & Regulatory

CDISC / SDTMGCP / ICH E6(R3)21 CFR Part 11Documentation for Regulatory

Clinical Data Management

Study Startup LeadershipDatabase BuildData Review & CleaningDatabase Lock & CloseoutEDC Systems & ConfigVeeva Vault CDBREDCapOracle

Communication & Translation

Regulatory & Governance DocumentationScientific Abstracts & PostersCross-Functional TranslationTechnical Training & MentoringPresentations & Facilitation

Live Tools & Products Live items link out · Gated items available on request

Live

AI Solution Quality & Risk ScorecardIndependent / Open Source · 2026

AIPythonRegulated IndustriesLive

Live

Trial Terms: Negotiation Prep for Clinical Data & R&D DealsIndependent / Open Source · 2026

StrategyNegotiationResponsible AIClinical OpsLive

Challenge

Providers and health systems have no structured, compliance-first way to discover and compare clinical AI models. Regulatory status, evidence level, and bias disclosures sit scattered across vendors, so model selection happens without governance.

Approach

Designed a clinical decision-support platform that puts regulatory status, evidence level, and documented limitations at the center of AI model discovery and comparison, with verified provider access and role-based controls.

Outcome

Gated demo showing compliance-first AI model discovery, comparison, and selection. Built on Base44. Full design available on request.

Request access to this demo

Challenge

People navigating chronic GI and autoimmune diagnostic limbo lack tools that combine daily symptom tracking, validated peer support, and doctor-ready summaries, leaving them without data or validation between appointments.

Approach

Designed a self-management app combining structured daily symptom tracking, peer support organized by symptom cluster, and plain-language summaries built for clinician visits, with personal health data scoped to its owner.

Outcome

Gated demo illustrating patient-centered tracking, community, and doctor-ready reporting. Built on Base44. Full design available on request.

Request access to this demo

Challenge

Job seekers, especially healthcare workers facing burnout, juggle pipeline tracking, interview prep, and negotiation across scattered tools, none of which blend emotional support with practical career strategy.

Approach

Designed a dual-variant platform (Opus for general professionals, Helix+ for healthcare workers) from a single codebase: a Kanban pipeline, automated Gmail and IMAP sync that builds the pipeline, AI fit scoring, mock interviews, resume tailoring, and wellness-first coaching. Tiered access with row-level security and a documented Terms and Privacy layer (CCPA/GDPR).

Outcome

Gated demo showing end-to-end job-search management with AI coaching, email-driven pipeline automation, and healthcare-specific interview and salary intelligence. Built on Base44.

Request access to this demo

Challenge

AI-assisted AE coding tools can introduce automation bias when the governance layer is absent: reviewers approve proposals without working exceptions, and weak matches or serious-event misclassifications go undetected.

Approach

Browser-based governance console built on a fully fictitious dummy study (VRN-204) with synthetic, non-patient data: AI proposes MedDRA terms with confidence scores; reviewers work exceptions (Approve / Remap with reason / Escalate to medical review). Designed against FDA 2025 AI guidance and 2026 FDA/EMA good AI practice: narrow context of use, risk-matched oversight, full decision provenance.

Outcome

Functional demo on dummy data, not a real study: illustrates compliant AI-assisted AE coding governance, where every decision logs reviewer, timestamp, and reason for audit readiness.

Request access to this demo

Challenge

Show a measurable physiological response to a calming intervention within a single hackathon day, without overclaiming from what an n=1 design can actually support.

Approach

Led measurement and methodology: designed a within-subject A/B protocol where the participant serves as their own control, moving through baseline, stress induction, intervention, and recovery while capturing HR, HRV (RMSSD), and self-reported distress. Built the honest-caveats framing directly into the deck (n=1, single session, fixed order, known confounds like decay and demand effects) so the result was never presented as more than a proof of concept.

Outcome

Presented a cumulative snapshot of the day's data capture, centered on a single-participant A/B run. The tool was shown live, though the session leaned on talking points and Q&A rather than a guided interactive walkthrough.

Request access to this demo

Challenge

No reusable framework existed for QC of continuous wearable sensor data across a pharma portfolio.

Approach

Outcome

Full framework delivered in under six months and ready for testing on formal handover; designed for reuse and structured for inspection readiness throughout.

Deployed in Kenya

Child Case Management Mobile AppKupenda for the Children · 2020–2021

mHealthUX DesignCommCareLive

Live

WAAI Website & Content InfrastructureWomen Applying AI (WAAI) · 2026

Web ContentAI CommunityManagementLive