Clinical Data Manager

Caroline Flessa, MPH

Greater Boston, MA • +1-508-***-**** • ********.*@***.*** • linkedin.com/in/cflessa Experienced professional in clinical and research data management. Adept at operational and vendor management, including: independently drafting/finalizing key project documentation and proactively collaborating with internal/external stakeholders to achieve milestones. Ready to contribute to the future of our industry in innovative ways. SKILLS

• Cardiology

• CDISC/SDTM

• Consulting Experience

• Creative problem solving

• Critical Thinking

• Cross Functional

Collaboration

• Data Integrity

• Data Transfer

• electronic Clinical Outcome

Assessment /eCOA

• Electronic Data Capture /

EDC

• Global experience

• Good Clinical Data

Management Practice /

GCDMP

• ICH Guidelines

• Industry standards

• Industry trends

• JIRA

• Leadership

• Manage multiple priorities

• Microsoft Office

• Oncology

• Project Management

• Public Health

• Python

• Quality Control

• R

• REDCap

• SAS

• SOPs

• SQL

• Timelines

• UAT

• Vendor Management

WORK EXPERIENCE

Pfizer • Cambridge, MA, USA • 11/2024 - Present

Associate Director, Data Operations

• Operational and vendor engagement point of contact for BEST within clinical studies

• Participate in monitoring DHT-derived data across asset teams

• Development of bespoke QC implementation strategy to support cleaning of device data

• Craft semi-automated QC process using Python tailored for data science needs

• Collaborate with Pfizer stakeholders to understand evolving portfolio needs and requirements

• Contribute technical expertise in design, implementation, upscale of certain DHT elements

• Recommend process improvements to existing data pipelines and workflows Kayentis • Boston, MA, USA • 05/2022 - 11/2024

Clinical Data Manager

• Provided Clinical Data Management (CDM) subject matter expertise at study start-up, implementing global studies

• Facilitated technical feasibility discussions, ensuring client requests aligned with protocol

• Drafted and finalized Data Management and Data Cleaning Plan (DMP/DCP) with Sponsor

• Led creation of design specs and edit checks to assist programming with study build and configuration

• Organized ad hoc calls for DM review, aligning and building strong relationships

• Achieved 100% quality checks passed upon test data delivery, ensuring efficient approval

• Took ownership over data transfer resource planning in JIRA, communicating timelines with internal/external stakeholders

• Contributed majorly to conceptualization/validation of custom reports automated by SAS

• Developed and delivered training to 4 DM colleagues to assist in departmental merge Clario • Medford, MA, USA • 03/2021 - 05/2022

Clinical Data Manager

• Served as primary CDM contact from start-up through closeout and lock, especially for query escalation/resolution and reconciliation

• Authored client-facing DM documents in collaboration with Sponsor, arranged ad hoc calls to review with external partners

• Successfully executed SAS code for all data transfers, utilizing prioritization and ensuring on-time delivery

• Led query management, delegated urgent queries to data coordinators, resolving issues quickly to ensure clean data transfers

• Aided in creation of monthly metrics reports, used for monitoring data transfer dates and other KPIs Carelon • Watertown, MA, USA • 03/2019 - 02/2021

Research Data Manager

• Utilized SAS code to QC de-identified data, ensuring company policies upheld

• Managed and executed UAT for online surveys and adjudication databases created by vendors

• Worked on development and completion of case report forms, codebooks, and other essentials for data collection

• Exchanged logs with vendors, recording QC measures and data security compliance for data transfers Open Health • Newton, MA, USA • 08/2018 - 01/2019

Research Assistant

• Contributed content and completed QC's for eCRFs, Investigator's brochures, dossiers, and promotional slide decks

• Conducted literature reviews and provided supporting evidence for specific patient population's unmet needs Boston University School Of Medicine • Framingham, MA, USA • 06/2016 - 07/2018 Framingham Heart Study

Research Assistant

• Led efforts to convert Medical History survey to e-version on REDCap, trained colleagues, shared feedback for continuous improvements

• Pulled participant data using SQL queries for bi-weekly mailings and annual reports

• Coded diagnostic criteria of medical events on special forms, manually entered into FHS database

• Maintained charts and FHS participant tracking system with demographic, morbidity, and/or mortality updates EDUCATION

MPH in Epidemiology & Biostatistics

Boston University School Of Public Health • 09/2020 BA in Major: Psychology & Minor: Sociology

Framingham State University • GPA: Cum Laude • 05/2016 CERTIFICATIONS

Investigator Site Personnel ICH GCP Training Certificate • 03/2025 Transcelerate Biopharma, Inc.

Good Clinical Practice for Investigational Site Staff • 03/2025 Firecrest/ICON

RCC User Management, Platform Overview Parts 1 + 2, Various Modules • 12/2024 REDCap Cloud

CommCare Certified App Building - Level 1 • 02/2020 Dimagi

AWARDS

ERT Endeavor Award, Clinical Data Manager • 07/2021 Clario

Research Award, Senior Major in Psychology • 05/2016 Framingham State University

VOLUNTEERING & LEADERSHIP

Kupenda for the Children • 02/2020 - 05/2021

Mobile App Development Consultant • Remote

East Boston Neighborhood Health Center • 07/2019 - 05/2020 Boston University MPH Practicum, Program of All-Inclusive Care for Elderly (PACE) Intern

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