Reena Naranjo
Springfield,USA
Summary
Strategic and people-centered clinical research leader with 22 years of experience delivering high-impact results in complex, multi-site clinical trials across biotech, pharmaceutical, and government sectors. Known for transforming operational efficiency, building cross-functional teams, and leading programs from concept through closeout in therapeutic areas such as infectious diseases, multiple sclerosis, TBI, asthma, and women’s health. Successfully managed IND and non-IND trials, registries, and cohort studies under FDA, ICH-GCP, and NIH guidelines, including a 17-year leadership tenure at Social & Scientific Systems (DLH). Trusted by sponsors and stakeholders to guide regulatory compliance, improve data integrity, and drive innovation in clinical operations.
Overview
23
23
years of professional experience
1
1
Certification
Work History
Co-founder, Director of Growth and Strategy
Consilium Research, LLC
09.2024 - Current
- Founded and lead a women-owned consultancy advancing research excellence for biotech, pharmaceutical, and federal sponsors.
- Architect operational frameworks and trial management tools to streamline startup, regulatory compliance, and cross-site coordination.
- Provide strategic guidance to early-phase trials and translational research initiatives, ensuring scientific integrity and operational execution.
- Foster inclusive, high-performance teams by aligning staff strengths with client goals and trial success metrics.
Project Manager, National Institute on Deafness and Other Communication Disorders (NIDCD)
CAMRIS International, Inc.
09.2024 - Current
- Spearhead the development of infrastructure for clinical trial readiness across the NIDCD extramural research portfolio.
- Lead design and implementation of over 35 standardized templates, SOPs, and operational guides for adoption across grantee institutions.
- Act as a clinical operations subject matter expert to investigators, ensuring alignment with NIH expectations and GCP standards.
Program Director – National Institute of Environmental Health Sciences (NIEHS) ID/IQ Contract
Social & Scientific Systems, Inc. (DLH Holdings Corp.)
05.2022 - 02.2024
- Directed a $7M/year clinical support services contract; ensured seamless delivery of complex administrative, programmatic, and cross-operational functions.
- Managed contract deliverables, timelines, staffing, and internal QA processes.
- Provided budget analysis and reporting.
- Collaborated with government sponsors to manage multiple task order portfolios and proactively mitigate contract risks.
- Managed multidisciplinary teams and served as a hiring lead and line manager across multiple task orders.
Project Manager – North American Multiple Sclerosis (MS) Registry Study
Social & Scientific Systems, Inc. (DLH Holdings Corp.)
08.2021 - 05.2022
- Led all phases of a multi-stakeholder registry study in MS, including protocol development, budget negotiation, IRB processes, site selection, and site management.
- Directed a multidisciplinary team including statisticians, data managers, academic investigators, and clinician-researchers.
Project Lead / Protocol Navigator – National Institute of Nursing Research (NINR) Resource Center
Social & Scientific Systems, Inc. (DLH Holdings Corp.)
09.2017 - 03.2021
- Directed a multidisciplinary team supporting non-IND studies in the intramural program.
- Promoted from protocol navigator to project lead in under one year based on performance and initiative, managing 8 staff across clinical, editorial, financial, and admin functions.
- Managed trial planning, IRB coordination, budget tracking, and sponsor reporting for complex behavioral and biomedical protocols.
Project Manager – AIDS Clinical Trials Group (ACTG) Network Coordinating Center
Social & Scientific Systems, Inc. (DLH Holdings Corp.)
06.2007 - 09.2021
- Oversaw end-to-end management of over 25 IND and non-IND HIV-related clinical trials across U.S. and global sites.
- Acted as liaison to protocol chairs, biostatistics teams, and clinical monitors to ensure compliance and data fidelity.
- Supervised a Scientific Committee Support Group with 12 staff, created over 100 internal SOPs/guidelines.
- Contributed to the network’s central management information system (MIS) quality assurance process, report development, and continuous enhancement activities.
- Served as a principal contributor to proposal strategy and technical writing for federal RFPs; led winning submissions for major projects.
Research Program Coordinator, Asthma Clinical Research Centers (ACRC) Network Coordinating Center
Johns Hopkins Bloomberg School of Public Health
10.2002 - 05.2007
- Supported multi-site asthma studies funded by the National Heart, Lung, and Blood Institute (NHLBI).
- Managed investigational product logistics; liaised with vendors and clinics; maintained IP supply reports.
- Ensured compliance with FDA and IRB regulations; wrote and reviewed protocols, consents, and regulatory submissions.
- Compiled materials for DSMB reviews and authored annual IND reports for regulatory agencies.
- Developed SOPs and served as a key contact for protocol interpretation and data quality resolution across the network.
Education
Master of Arts - Health Communication
The Johns Hopkins University
Washington, DCBachelor of Arts - Biopsychology
University of Maryland Baltimore County
Baltimore, MDSkills
- Clinical Operations
- IND/Non-IND Trial Management
- Regulatory Compliance
- Publication & Abstract Support
- NIH-Funded Research
- SOP Development
- Contract Oversight
- Risk Management
- Trial Startup & Closeout
- Budgeting & Forecasting
- Proposal Writing
- Cross-functional Stakeholder Engagement
- Relationship & Team Building
- Sponsor Collaboration
- Continuous Improvement
- Approachable Leader
Certification
- PMP, Project Management Institute, 2007, Active
- CCRP, Society of Clinical Research Associates, 2007, Active
Citi Program Trainings
- Biomedical Responsible Conduct of Research
- Social and Behavioral Responsible Conduct of Research
- GCP for Clinical Trials with Investigational Drugs and Biologics
- Biomedical (Biomed) Comprehensive
- FDA Inspections: From Site Preparation to Response
- IRB Administration
- Refresher Course – Human Subjects Research (Social/Behavioral Research Course)
- Conflicts of Interest
- Information Privacy Security
Therapeutic Areas and Clinical Trial Designs
- Infectious Diseases
- Women’s Health
- Multiple Sclerosis
- Traumatic Brain Injury
- Asthma
- Fatigue
- HIV
- Tuberculosis
- HPV
- Phase I–III Trials
- Behavioral & Observational Studies
- Registries
- Epidemiological Cohorts
- International Trials
- FDA-regulated INDs
Timeline
Co-founder, Director of Growth and Strategy
Consilium Research, LLC
09.2024 - Current
Project Manager, National Institute on Deafness and Other Communication Disorders (NIDCD)
CAMRIS International, Inc.
09.2024 - Current
Program Director – National Institute of Environmental Health Sciences (NIEHS) ID/IQ Contract
Social & Scientific Systems, Inc. (DLH Holdings Corp.)
05.2022 - 02.2024
Project Manager – North American Multiple Sclerosis (MS) Registry Study
Social & Scientific Systems, Inc. (DLH Holdings Corp.)
08.2021 - 05.2022
Project Lead / Protocol Navigator – National Institute of Nursing Research (NINR) Resource Center
Social & Scientific Systems, Inc. (DLH Holdings Corp.)
09.2017 - 03.2021
Project Manager – AIDS Clinical Trials Group (ACTG) Network Coordinating Center
Social & Scientific Systems, Inc. (DLH Holdings Corp.)
06.2007 - 09.2021
Research Program Coordinator, Asthma Clinical Research Centers (ACRC) Network Coordinating Center
Johns Hopkins Bloomberg School of Public Health
10.2002 - 05.2007
Master of Arts - Health Communication
The Johns Hopkins University
Bachelor of Arts - Biopsychology
University of Maryland Baltimore County
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