Summary
Overview
Work History
Education
Skills
Timeline
Therapeuticareaexpertise
Studytypes
Professional Highlights
Military Service
Therapeutic Areas & Indications of Expertise
Study Types
Professional Highlights

Iliana Maldonado

Mansfield,TX

Summary

Diligent experienced Clinical Trial Manager and Sr. Clinical Research Professional with over 17 years of experience and a proven record of overseeing more than 100 IVD, medical device, and complex drug clinical trial studies from inception to completion. Skillfully manage cross-functional teams to ensure project milestones are met within timelines. Strong analytical capabilities and leadership skills. Extensive background in managing comprehensive study protocols and data management. Advanced skills and strategic planning that drives successful project completions. Foster team collaboration, and communication, ensuring high-quality data integrity, meeting stringent regulatory standards, lending to overall development, process optimization, and enhanced operation improvements. With a deep understanding and passion for clinical research, seamlessly allows prioritizing excellence and upholding a strong work ethic, resulting in a highly productive work environment.

Overview

12
12
years of professional experience

Work History

Clinical Trials Study Manager

Quest Diagnostics
10.2021 - 04.2024
    • Lead trial manager independently directed multiple concurrent clinical research IVD studies
    • Led coordination and execution of phase I, II, III, and IV global clinical trials for leading esoteric laboratory, overseeing cross-functional teams domestically and across EU, South America, Canada, and Asian countries enhancing enrollment
    • Total oversight of study regarding quality, expenses, and schedule adherence
    • Managed annual $11M trial budget, study sites, and agreements refining resource allocation and reducing overhead
    • Implemented risk-based monitoring approach, increasing data quality and efficiency
    • Formulate technical study designs in partnership with both internal and external specialists, along with operation and development teams
    • Direct line management responsibility of junior-level study management and trial support teams
    • Ensures all studies are planned, executed, monitored, and closed out without compromise of study synopsis
    • Manage and own stakeholder relationships
    • Continuous oversight and maintenance of data management processes, ensuring data quality, results, reporting, and database closure from inception to completion including archiving
    • Ensure compliance of applicable standards and regulations associated with clinical trial and laboratory conduct
    • Develop and draft study protocols, project plans, standard operating procedures, and monitoring reports
    • Managed all aspects of study close-out, ensuring timely delivery of final reports and proper archival of essential documentation for future reference or regulatory inspection purposes.
    • Led regular status update meetings with internal teams and clients, ensuring transparency and alignment on project progress.
    • Established strong relationships with key stakeholders, facilitating open lines of communication and fostering collaborative working environment.
    • Collaborated with quality assurance teams to ensure all aspects of study adhered to strict regulatory guidelines at every stage.

Medical Monitor, Safety Quality Assurance

Alcon
11.2019 - 06.2021
    • Oversight of quality case management of technical and adverse event complaint records, reported by customers and healthcare providers involving client devices and products
    • Manage approximately 30 new cases daily of technical and adverse events stemming from intake, customer communications, triage, and system entry
    • Review and assess all medical safety case accountabilities, reflect the required local and international regulations, FDA guidelines, and comply with applicable directives for HCPs, patients, and internal Client personnel
    • Assure all information/data is accurately captured from the point of contact to ensure required compliance with regulations and directives
    • Manage and review ongoing technical and adverse event medical safety cases using designated safety system(s) ensuring data entry activities and corresponding source documents are processed promptly per local and international regulations and guidelines for assigned therapeutic areas requirements
    • Monitor safety databases and reporting tools to identify potential issues and emerging trends.

Sr. CRA & Neurocognitive Rater

Pillar Clinical Research, LLC
01.2016 - 10.2019
    • Managed and maintained a clinical laboratory compliant with routine OSHA-recommended safety and biohazard maintenance
    • As the delegated pharmacist, dispensed treatment and performed accountability of investigational products including schedule II drugs
    • Shipping and transport of Category A, infectious substances affecting humans, Category B biological substances, and dangerous goods
    • GCP and NIH training for clinical research conduct and facilitate designated clinical research studies
    • Completing study procedures per protocol, data entry, query resolution, trained in multiple EDC systems, phlebotomy, and EKG
    • Managed between 9 and up to 17 clinical research studies simultaneously, in conjunction with sponsor CRAs and affiliates on IMVs, SIVs, and RMVs, protocols, amendments, and continuing reviews
    • Assist in the creation and maintenance of associated study documents and tasks
    • Mentored research assistants, coordinators, and junior staff on study policies and procedures

Clinical Research Manager & Team Lead

St. Jude Medical
08.2013 - 01.2016
    • Led a 10-person team, which later expanded to a team of 25 people
    • Trained staff on investigational tasks and responsibilities as part of the response to the FDA, associated with a 483 warning letter on a medical device and associated components
    • Performed the required device history record (DHR) review for the Neuro-modulation Department complaint unit that met criteria standards for clients implanted with SJM implantable electronic system devices
    • DHR team lead providing support conducting internal audits, peer reviews, and mentoring
    • Create/Conduct individual and team presentations for upper management, unit, and department directors

Assistant Clinical Research Manager & Coordinator

UT Southwestern Medical Center
05.2012 - 07.2013
    • Initial team member of pilot program for clinical research within academic sector. Apart of 'pool' of experienced clinical research specialists capable of supporting strict requirements, infrequent needs across different specialties/departments, and often short study timelines of grant-funded studies
    • Primary coordinator of assigned studies and backup coordinator for secondary studies.
    • Assistant research manager, work on-call schedule
    • Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
    • Assessed patients'' eligibility criteria following strict adherence to inclusion/exclusion guidelines.
    • Managed patient recruitment, informed consent process and data entry to support trial objectives.
    • Developed and maintained accurate and up-to-date case report forms and source documents.
    • Prepared and maintained regulatory documents for clinical trial submissions.

Education

MBA - Healthcare Management

American InterContinental University, Buckhead, GA
09.2007

Degree achieved

BBA - Business Administration

American InterContinental University, Buckhead, GA
06.2006

Degree achieved

Skills

  • Phase I - IV Clinical Trial Management
  • Global Study & Project Management
  • Self Motivated
  • Team Leadership & Multitasking Abilities
  • Clinical Development & Operations
  • Quality Assurance Regulatory Compliance
  • CRO & Investigator Relations
  • Data Management & Validation
  • Pharmacovigilance awareness
  • Management of Study Sites & Agreements
  • Stakeholder Communication & Vendor Management
  • Clinical Trial Management Systems
  • UAT, EDC, TMF, & eTMF
  • Protocol & SOP Drafting & Compliance
  • Auditing, FDA & Internal
  • ICH/GCP Adherence & Guidelines
  • Data Monitoring Plans
  • Training and Development of Jr Staff

Timeline

Clinical Trials Study Manager - Quest Diagnostics
10.2021 - 04.2024
Medical Monitor, Safety Quality Assurance - Alcon
11.2019 - 06.2021
Sr. CRA & Neurocognitive Rater - Pillar Clinical Research, LLC
01.2016 - 10.2019
Clinical Research Manager & Team Lead - St. Jude Medical
08.2013 - 01.2016
Assistant Clinical Research Manager & Coordinator - UT Southwestern Medical Center
05.2012 - 07.2013
American InterContinental University - MBA, Healthcare Management
American InterContinental University - BBA, Business Administration

Therapeuticareaexpertise

  • Neurology - Central Nervous System (CNS)
  • Psychiatry
  • Oncology
  • Cardiology
  • Ear, Nose, & Throat
  • Pathology
  • Infectious Disease
  • Molecular
  • Chemistry
  • Microbiology

Studytypes

  • IVD: Pilot, Feasibility, Comparator & Reproducibility, some requiring an honest broker
  • Clinical: Interventional & Observational, unblinded, blinded, & double-blind

Professional Highlights

  • Independently managed & conducted over 250 In Vitro Diagnostic (IVD) & clinical trials.
  • Led over $7 million in study contracts over the past 2+ years with consistent oversight of the scope of work, assessment of ongoing & potential new contracts, routine review of awarded contracts identifying any requirement of an amendment or change orders for assigned IVD, 510K submissions & clinical study contracts.
  • Adept in all phases of research, I, IIa, IIb, III, and post-market clinical trials. Expertise in data management and regulatory compliance. Advanced proficiency of FDA guidelines, 21 CRF Part 820, and ICH GCP standards. Competent with UAT, CRF/eCRF design, data analysis and reconciliation of clinical trial databases, validation programming, and implementation with an exceptional standard of accuracy.

Military Service

United States Marine Corp, Medically Discharged under honorable conditions

Therapeutic Areas & Indications of Expertise

  • Neurology - Central Nervous System (CNS)
  • Psychiatry
  • Oncology
  • Cardiology
  • Ear, Nose, & Throat
  • Pathology
  • Infectious Disease
  • Molecular
  • Chemistry
  • Microbiology

Study Types

  • IVD: Pilot, Feasibility, Comparator & Reproducibility, some requiring an honest broker
  • Clinical: Interventional & Observational, unblinded, blinded, & double-blind

Professional Highlights

  • Independently managed & conducted over 250 In Vitro Diagnostic (IVD) & clinical trials.
  • Led over $7 million in study contracts over the past 2+ years with consistent oversight of the scope of work, assessment of ongoing & potential new contracts, routine review of awarded contracts identifying any requirement of an amendment or change orders for assigned IVD, 510K submissions & clinical study contracts.
  • Adept in all phases of research, I, IIa, IIb, III, and post-market clinical trials. Expertise in data management and regulatory compliance. Advanced proficiency of FDA guidelines, 21 CRF Part 820, and ICH GCP standards. Competent with UAT, CRF/eCRF design, data analysis and reconciliation of clinical trial databases, validation programming, and implementation with an exceptional standard of accuracy.

Similar Profiles

CREATE PROFILE
Iliana Maldonado