Wanda Ivelisse Melendez
Burnsville,USA
Summary
Clinical Research Data Manager with 20 years of experience with Phase I – Phase IV studies (pharmaceutical and medical device). Foundational background in academic research. Proficiency with industry Data Management processes, procedures, and best practices. Collaborates well with patients, providers, pharmaceutical companies, regulatory and medical affairs, safety, biostatics, data management, clinical research and site management associates, pharmacovigilance, and QA. Well-versed in ICH guidelines, Good Clinical Practice (GCP), HIPAA, and AE / SAE / SADR tracking.
Overview
22
22
years of professional experience
1
1
Certification
Work History
Program Clinical Data Manager
Worldwide Clinical Trials
Research Triangle Park, USA
04.2024 - Current
- As Program Clinical Data Manager, my role is to manage the client relationship of the assigned client
- To represent WCT at meetings with the key client, and in all dealings with the client’s staff with respect to Data Management
- Experience in supervisory role level data management activities and mentoring others, database build and database lock plans, and dealing with vendors for data transfers, and manage all aspects of study within Data Management responsibilities
- To manage the trials of the assigned client, providing leadership and management to the corresponding data management team
- Collaborate with other WCT departments working with the same client
- To take responsibility for the training, development and performance of assigned staff
- To ensure that all data management operations are conducted to WCT SOPs; contributing to the ongoing revision/improvement of these SOPs
- To coordinate the design of the paper or electronic Case Report Form as required
- To write specifications for the set-up and modification of project specific data entry and consistency checking software for assigned trials (such as reconciliation and EDC database build specifications)
- To co-ordinate those aspects of adverse event management and central event adjudication which relate to assigned projects and to write or approve the corresponding manuals/guidelines
- To represent WCT in dealings with Endpoint committees or their designates, as required
- To participate as required in sponsor audits, regulatory authority inspections and other third-party meetings
- Ensure than any recommendations are discussed and that solutions are incorporated
Senior Portfolio Lead / Project Manager
eClinical Solutions LLC
Mansfield, USA
11.2021 - 04.2024
- Manage Data Management related aspects for customer's program
- Serve as the Customer's Subject Matter Expert (SME) on Data Management topics and strategies
- Also serve as study Data Manager for 3 of my 5 portfolio studies and Project Manager for my portfolio
- As Project Manager I am responsible for the successful initiation, planning, execution, monitoring, controlling, and closure of a project in collaboration with Delivery Managers
- Responsible for strategic oversight of assigned Customers
- Also, identify areas for process and systems innovation and implement change that will enhance the overall effectiveness of the team
- Collaborates with the study project team on overall data management strategy for a customer's program of studies, assuring overall quality and efficiency
- Provide proactive, timely verbal and written communication of Customer's program status, data trends and issue resolution with internal team and Customers
- Performs peer reviews of key Data Management study documents or other Data Management deliverables to assure quality of content and, where appropriate, consistency across a customer's program of studies
- Provide training and develop training of Data Management staff
- Apply data-driven methods to make informed decisions about solutions, deliveries, and teams
- Track team trainings and PTO
- Acts as an escalation path for internal teams in relation to a customer's program challenges or issues
- Serve as a point of contact for the client when multiple functional areas are assigned to the project to ensure team actions
- Maintains the project schedule/timelines and ensures project stays within scope/budget
- Take and maintain all project minutes, facilitate meetings including kick-off meetings, and online CRF review meeting
- Attend Governance meetings
- Supervisory role within portfolio
- Track and update milestones and initiate any work order changes
- Request study access activities, maintain Data Services Clinical Operations and Governance Plan
- Obtain all study approvals, track risks, and action items
Senior Clinical Data Manager
eClinical Solutions LLC
Mansfield, USA
05.2021 - 11.2021
- Served as the primary representative for eCS/Sponsor data management interaction, ensure eCS data management process is followed and deliverables meet quality and timelines within approved Scope
- Senior technical resource providing Data Management services for project requirements including Protocol Conversion, Database Build, CRF design, Data Entry, Data Verification, Data Review, Query Management
- Define specifications and collaborate with technical team on configuration of centralized data management platform, elluminate Data Central for data cleaning strategy and oversight activities
- Perform Quality Control on deliverables developed by team members including study documents, program and report specifications, deliverables and elluminate Data Central, data analysis, and analytics modules
- Function as senior OM consultant to sponsor providing guidance on data management best practices as applied to sponsor and protocol specific situation
- Perform data trending review via reporting and elluminate analytics to identify risks and develop mitigation and data cleaning strategies
- Delegate and prioritize tasks, provide support and guidance to study data management team mentoring junior level staff and peers on all associated tasks within a study helping to grow individual capabilities
- Support business development by participating in proposal defenses
- Maintain project documentation related to assigned tasks
Clinical Data Manager
eClinical Solutions LLC
Mansfield, USA
12.2020 - 05.2021
- Served as Clinical Data Manager in phase I and II studies
- Provided Clinical Data Management support in study start-up, conduct, and study close
- Assist with Data Management deliverables including DMPs, CRFs, CRF Completion Guidelines, edit checks, UAT testing and data review plans
- Assist with creation/review of data transfer agreements (OTAs) between external data vendors and/or core labs
- Reconcile electronic data transfers from external vendor ensuring data in alignment with the DTAs
- Assist and/or lead data cleaning activities such as data cleaning in EDC or via data listings, generate queries, review, and close answered queries
- Run and review data management metrics standardized reports
- Identify data trends and communicate to the Clinical Data Management team
- Collaborate with the Clinical Data Management team for the project to ensure the deliverables are completed on time with high quality
- Attend internal and sponsor study team meetings
Clinical Data Coordinator -CRO
ICON plc
Dublin, Ireland
06.2014 - 06.2020
- Served as Clinical Data Coordinator / Clinical Data Management and managed up to 10 late phase (Phase IIIb and IV) for pharmaceutical clients with thousands of subjects globally
- Provided study teams with deliverables and reports (e.g., enrollment, query management, site management, coding reports, and missing data)
- Collaborated with 14 companies to support study launches by performing user acceptance testing (UAT), validations during database build, testing edit functions, DMP, eCRF Completion guidelines, eCRF design
- Wrote and reviewed internal SOPs
- Monthly data cleaning with line listings
- Conducted WHO Drug and MedDRA coding for at least five clinical trials, managed and conducted the upgrade of coding dictionaries for studies including coordinating external resources, and worked closely with medical monitor, data manager, safety, programmer, vendors, and sponsor
- Performed monthly, quarterly, and annual reconciliation for records related to AE (adverse event), and SAE (severe adverse event) to assure consistent data capture for client
- Extracted data; locked and archived studies
- Archived study data in electronic trial master file (eTMF)
- Provided direct and indirect (through CRAs and SMAs) support to study sites with data entry, call center triage, and query resolution as well as startup and closing activities
- Entered patient research data; ran SAS programs
- Conducted audits of Case Report Form (CRF) data for completeness, accuracy, and consistency
- Provided technical support, administrative support, and trained internal staff, sites, and sponsor for Smart Measurement Systems (SMS System) which housed data from at least 20 studies including user training, access, issues, permissions, and passwords
Sr. Clinical Study Coordinator / Site Management Associate
Alliqua BioMedical, Inc.
Eden Prairie, USA
06.2013 - 06.2014
- Managed / tracked study enrollments for 10 US sites as part of study team for non-contact ultrasound device for wound care
- Assisted sites with study start up, patient enrollment process, closure, supplies, database questions, and ensure site compliance with study protocols and Institutional Review Board (IRB) requirements
- Maintained study sites’ regulatory binders
- Assisted CRA during site monitoring visits and with adverse events
- Conducted local monitoring visits to hospitals and clinics
- Performed study reports to track enrollments and resolve missing data or PROs for sites
- Reviewed CRF; tracked and requested study payments
- Conducted study database lock down
- Performed double pass data entry, data entry review, documenting deviations, and query management / resolution
Clinical Study Coordinator / In-House CRA Medical Device
American Medical Systems
Minnetonka, USA
11.2009 - 10.2012
- Served on study team that managed several registry studies and phase studies in Women’s Health Urinary Incontinence Division across 35+ sites in US, Africa, Europe, and Australia
- Worked with study team to write data management plan, data entry rules, and study final report
- Conducted local monitoring visits as needed
- Handled data management, study start up and closure, site enrollment tracking, study database administration, and ad hoc reports
- Set-up and filed documentation in central eTMF
- Communicated with physicians and staff; worked with monitors during site visits
- Worked with legal to prepared site contracts and collected final contracts and budgets
- Reviewed case report forms, assisted sites with enrollment process, tracked and shipped site study supplies, and tracked / issued study payments
- Performed data entry in study databases; issued and resolved study queries; reconciled data related to devices and adverse events
- Assisted in Investigator Meeting planning and execution
- Monitored adverse events for study sites and ensured proper reporting for regulatory bodies by jurisdiction, FDA, and internal governance within AMS
- Maintained study sites’ regulatory binders and ensured sites were compliant with IRB or requirement regulations across all countries
- Assist with the document translation, SOP development, and protocol development
Clinical Research Coordinator
Radiant Research
Edina, USA
10.2005 - 04.2006
- Coordinated pharmaceutical trials and device studies in cardiology, diabetes, obesity, pain, allergy, headaches, sleep, vaccines, hormone therapy, arthritis, and osteoporosis
- Recruited, enrolled, and educated study patients; conducted study visits and drug accountability, completed CRFs
- Tracked / reported AEs to sponsor and FDA
- Scheduled patients for follow up visits
- Performed patient vitals, labs, ECGs, diabetes testing, allergy testing, vaccinations, and any other study required tests and procedures; shipped study samples collected during visits; and scheduled patients for external study requirements such as x-rays or scans
- Conducted mass screenings for cardiology, allergy, diabetes, and vaccine studies
- Organized patient binders; signed records; obtained PI signatures; and submitted paper CRFs to sponsor
- Collaborated with study monitors to address any corrections to monitoring logs and address study queries
- Managed study IRB requirements for startup, during, and closure responsibilities
- Submitted any necessary documents and reports to IRB and clients
Research Study Data Coordinator
Park Nicollet Community Clinical Oncology Program (CCOP)
St. Louis Park, USA
01.2003 - 10.2005
- Managed North Memorial Health, Mercy, and Unity Hospitals study patients for participation in ~ 350 Phase I – IV clinical trials through National Cancer Institute, US Oncology, pharmaceutical and independent hospital research
- Delivered study drugs and conducted drug accountability for sites; managed IRB regulatory binders; assisted with collection of vitals, patient binders, data collection of CRFs, informed consents, questionnaires, logs, and other clinic requirements
- Prepared study binders and collected necessary images, scans, or documents for extensive preparation for annual FDA audits and ongoing internal audits for quality control
- Responded to unanticipated or ad hoc audit needs
- Followed over 5K patients, including those who were deceased
- Completing CRFs for those in long-term follow up through phone / mail outreach and contacted cancer registries for information
- Collected retrospective data, images, and scans to evaluate trends and identify new findings or new possible treatment applications
Education
BS - Biology / Chemistry
Texas Woman's University
Denton, TXSkills
- Medrio
- Smart Measurement Systems
- Medidata Rave EDC
- Medidata Coder
- Zelta EDC
- Clindex EDC
- InForm EDC
- InForm Coder
- Oracle EDC
- Registrak CTMS system
- SmartSheet
- IRT
- IVRS system
- Elluminate
- Trial Interactive System
- Medidata Rave TMF
- Veeva System
- Immunocytochemistry
- Immunohistochemistry
- Immunoassay
- Immunofluorescence
- Immunoblotting
- In-situ hybridization
- Lowry’s Protein Assays
- Spectrophotometry
- Quantitative Analytical Chemistry
- Histology
- Tissue Culture
- EM and SEM-EDX Microscopy
- HPLC Analyses
- Neurology
- Rare Disorders
- Wound Care
- Oncology
- Endocrinology
- Dermatology
- Gastroenterology
- Immunology
- Infectious Diseases
- Urology
- Allergy
- Vaccines
- Rheumatology
- Pulmonology
- Cardiology
- Genetic
- Brain injury
- Trauma
- Spinal Cord
- Headaches
- Sleep Disorders
- Wound Healing
- Skin
- Lung
- Breast
- Cervical
- Colon
- Rectal
- Gastrointestinal
- Liver
- Kidney
- Leukemia
- Testicular
- Uterine
- Prostate
- Ovarian
- Pancreatic
- Thyroid
- Oral
- Biomarker
- Diabetes
- Hormones
- Obesity
- Psoriasis
- Burns
- Inflammatory Bowel Disease
- Crohn’s Disease
- GERD
- IBS
- Ulcerative Colitis
- Hepatitis
- Tuberculosis
- Asthma
- Autoimmune
- Rare diseases
- Animal Health
- Dentistry
- Small Animals
- Large Animals
- Cats
- Dogs
- Pigs
- Mice
- Rats
- Prolapse
- Urinary Incontinence
- Pelvic prolapse
- Urinary Tract Infections
- Dry Eye
- Glaucoma
- Retinal genetic diseases
- Musculoskeletal Disorders
- Connective Tissue Disorders
- Osteoarthritis
- Psoriatic Arthritis
- Rheumatoid Arthritis
- Osteoporosis
- Pain
- Hypercholesterolemia
- General Cardiovascular
- Chronic Obstructive Pulmonary Disease
Selected Publications
- Therapy-resistant Itch After Major Burn Injury, Nelson, R.D., Solem, L.D., Ahrenholz, D.H., Melendez, W.I., Cole, J.B., Abstract, Regions Hospital Department of Surgery, 1999
- Immunocytochemical Localization of Sodium-Calcium Exchanger in Canine Nephron, Bourdeau, J.E., Taylor, A.N., Iacopino, A.M., J. AM. Soc. Nephrol, 4, 105-110, 1993
Certification
Certification for Clinical Research Professionals (CCRP), Society of Clinical Research Associates
Clinical Therapeutic Expertise
- Neurology
- Rare Disorders
- Wound Care
- Oncology
- Endocrinology
- Dermatology
- Gastroenterology
- Immunology
- Infectious Diseases
- Urology
- Allergy
- Vaccines
- Rheumatology
- Pulmonology
- Cardiology
- Genetic
Laboratory Skills
- Immunocytochemistry
- Immunohistochemistry
- Immunoassay
- Immunofluorescence
- Immunoblotting
- In-situ hybridization
- Lowry’s Protein Assays
- Spectrophotometry
- Quantitative Analytical Chemistry
- Histology
- Tissue Culture
- EM and SEM-EDX Microscopy
- HPLC Analyses
Timeline
Program Clinical Data Manager
Worldwide Clinical Trials
04.2024 - Current
Senior Portfolio Lead / Project Manager
eClinical Solutions LLC
11.2021 - 04.2024
Senior Clinical Data Manager
eClinical Solutions LLC
05.2021 - 11.2021
Clinical Data Manager
eClinical Solutions LLC
12.2020 - 05.2021
Clinical Data Coordinator -CRO
ICON plc
06.2014 - 06.2020
Sr. Clinical Study Coordinator / Site Management Associate
Alliqua BioMedical, Inc.
06.2013 - 06.2014
Clinical Study Coordinator / In-House CRA Medical Device
American Medical Systems
11.2009 - 10.2012
Clinical Research Coordinator
Radiant Research
10.2005 - 04.2006
Research Study Data Coordinator
Park Nicollet Community Clinical Oncology Program (CCOP)
01.2003 - 10.2005
BS - Biology / Chemistry
Texas Woman's University
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