Wendy Oden
Summary
Detail-oriented clinical research professional with 8 years experience in the research industry. Strong organizational, problem solving, and planning skills with ability to handle multiple projects simultaneously.
Therapeutic experience: Oncology, Ophthalmology, Cardiovascular Disease, Endocrinology/Metabolic Diseases, Genitourinary, Infectious Disease, and Respiratory Disease.
Indication Experience: T-cell Lymphoma, Myelodysplastic Syndrome, Breast Cancer, Dedifferentiated Liposarcoma, Macular Degeneration, Diabetes Mellitus type 2, Pediatric Diabetes, Overactive Bladder, Hypertension, Hyperlipidemia, Vaginal Atrophy, Endometriosis, Herpes Zoster, COPD, and HIV.
Overview
23
23
years of professional experience
Work History
ASSOCIATE CLINICAL OPERATIONS LEAD
PAREXEL
02.2023 - Current
- Function in support of the Project Lead for multiple trials in Oncology
- Partner with cross functional groups in operational activities including conduct and completion of trials
- Provide leadership and direction to project team members
- Prioritize effectively and respond to urgent requests within team or from sponsor
- Manage study start up activities through project closeout
- Assist with ensuring all team members have access to necessary tools and documents
- Provide performance feedback on team members as appropriate
- Support development of study plans, tools, and forms
- Address identified and escalated site issues and follow to closure
- Monitor study timelines, patient recruitment, retention and data cleaning to ensure successful outcome
- Prepare and participate in and follow up on audits and inspections
- Proactively prepare for timelines such as database locks, interim analysis, and other key deliverables
- Support early recognition of areas of potential problems and provide input to contingency plans
- Review and approve monitor visit reports and site closeout reports
MEDICAL RESEARCH ASSOCIATE
PAREXEL
03.2022 - 02.2023
- Functioned in support of the Clinical Trial Manager for trials of varying therapeutic areas
- Partnered with cross functional teams in operational activities including start up, conduct, and closeout of clinical trials
- Built and maintained positive relationships internally cross functional teams and externally with clinical trial sites
- Managed various aspects of clinical trials including vendor access, clinical trial documentation, clinical supplies, and timelines for deliverables
- Provided guidance to clinical monitoring team and regulatory teams during the clinical trial
- Served as the first line of contact for site staff for trial related questions
- Communicated data findings to appropriate team members and provided guidance to sites as needed
- Maintained quality, performance, and operational oversight for assigned sites, issue escalation, implementation of mitigation strategies and provided solution-based recommendations cross functionally
- Updated and maintained trial-specific systems, databases, and trackers such as CTMS, metrics, IVRS, and Excel spreadsheets to ensure data quality and integrity
- Supported site and sponsor inspection readiness activities
- Played an active role within the clinical team to help reach project goals, achieve deliverables, and meet project timelines
- Utilized knowledge to proactively prepare for timelines such as data base locks and key deliverables
- Participated in trial team meetings including vendor meetings, Investigator meetings, Country Trial Oversight meetings along with the creation and distribution of meeting minutes
- Remained in close contact with sites to assist with query resolution and/or missing data
Sr RSM-L
PPD
07.2020 - 03.2022
- Performed all aspects of in-house site management in accordance with good clinical practices
- Served as the primary point of contact for study site staff
- Performed regularly scheduled site management calls with study sites to support the sites' execution of their study responsibilities
- Followed findings / issues to resolution through site management contacts as well as ad hoc communication with site staff
- Utilized technologies to run reports, explore metrics, assist sites with query resolution and/or missing data
- Ensured study site contacts are updated as needed and site essential site document management
- Ensured study systems were updated per agreed study conventions (e.g., Clinical Trial Management System - CTMS) to ensure adequate communication to project team and sponsor as well as to facilitate timely site payments
- Played an active role within the clinical team to help reach project goals, achieve deliverables, and meet project timelines
- Utilized knowledge to proactively prepare for timelines such as data base locks and key deliverables
- Attended Investigator Meeting and collaborated with Sponsor, PPD Team, and site staff.
TEACHER/NURSE
TATUM ISD
08.2016 - 07.2020
- Taught Medical Terminology and Principles of Health Science to grades 9-12
- Demonstrated and instructed various health care related skills and proper techniques to students
- Provided nursing care and physical screening to students
- Assessed students and implemented first aid measures as needed
- Maintained and recorded vaccination records for 400 plus students and transposed records into appropriate school computer software.
STUDY COORDINATOR
DIAGNOSTIC CLINIC CENTER FOR CLINICAL RESEARCH
05.2012 - 08.2016
- Overseen the daily activities of clinical research studies while protecting subject safety and reporting accurate study data
- Ensured that studies at site were conducted according to ICH-GCP guidelines
- Recruited, screened, and participated in the consenting process of participants for clinical trials
- Ensured quality, consistency, and accuracy in the conduct of clinical research trials and completed and maintained case report forms including paper and eCRFs
- Monitored for and reported SAEs as per protocols
- Performed investigational drug administration and accountability
- Performed lab draws and assessments per protocol
- Created trial specific source documentation
- Assessed patient eligibility prior to PI overview of eligibility criteria
- Provided patient education regarding use of trial supplies such as diabetic testing equipment, eDiaries, and paper diaries.
- Attended investigator meetings
LICENSED VOCATIONAL NURSE/OFFICE MANAGER
N.B. RIDDLE, MD
09.2003 - 05.2012
- Performed direct patient care including injections, venipunctures, in office lab work, and vital signs
- Assisted physician with minor skin surgeries
- Conducted office duties such as: insurance billing, payment posting, patient accounts, office deposits, federal tax payments, monitor physician licensing, supply ordering, scheduling, medication refills, medication prior authorizations, answering multiple phone lines, and benefit verification.
LICENSED VOCATIONAL NURSE
LARRY SMITH, MD
02.2001 - 09.2003
- Performed in office dermatology nursing duties such as: collected patient history, routine injections, surgery scheduling, assisted physician with skin surgeries, typed physician dictation, performed tissue dissection, and staining for MOH's surgery, sterilization of instruments, assisted physician with written prescriptions, and documentation
- Gained significant knowledge of and treatment of skin disorders such as acne, actinic keratosis, alopecia, skin ulcers, decubitus ulcers, dermatitis, eczema, impetigo, molluscum contagiosum, psoriasis, rosacea, urticaria, warts, basal cell carcinoma, squamous cell carcinoma, and melanoma
Education
B.Sc. - Health Science
West Texas A&M University
Canyon, TX08.2019
AGS - General Studies
Panola Junior College
Carthage, TX08.2018
Licensed Vocational Nurse -
Kilgore Junior College
Kilgore, TX12.1999
Skills
Clinical Trial Operations
Clinical Trial Management Systems (CTMS)
Regulatory Documentation
Vendor Management
Site Management
Cross Functional Collaboration
Leadership
Good Clinical Practice
Informed Consent
Clinical Monitoring
Affiliations
Member of the Association of Clinical Research Professionals, USA, since 2015
Licenses Certificates
- Certified Clinical Research Coordinator, Association for Clinical Research Professionals, 01/2015
- Licensed Vocational Nurse, Texas State Board of Nursing, 02/2000
Languages
English
Timeline
ASSOCIATE CLINICAL OPERATIONS LEAD
PAREXEL
02.2023 - Current
MEDICAL RESEARCH ASSOCIATE
PAREXEL
03.2022 - 02.2023
Sr RSM-L
PPD
07.2020 - 03.2022
TEACHER/NURSE
TATUM ISD
08.2016 - 07.2020
STUDY COORDINATOR
DIAGNOSTIC CLINIC CENTER FOR CLINICAL RESEARCH
05.2012 - 08.2016
LICENSED VOCATIONAL NURSE/OFFICE MANAGER
N.B. RIDDLE, MD
09.2003 - 05.2012
LICENSED VOCATIONAL NURSE
LARRY SMITH, MD
02.2001 - 09.2003
B.Sc. - Health Science
West Texas A&M University
AGS - General Studies
Panola Junior College
Licensed Vocational Nurse -
Kilgore Junior College
Similar Profiles
Malarvizhi DhanapalMalarvizhi Dhanapal
TMF Lead at ParexelTMF Lead at Parexel
SREERANJINI VENKATAKRISHNANSREERANJINI VENKATAKRISHNAN
Internal Auditor at PAREXELInternal Auditor at PAREXEL
Sean BlackwoodSean Blackwood
Financial Analyst II at ParexelFinancial Analyst II at Parexel
Dennis Chirstian MondaresDennis Chirstian Mondares
Clinical Research Associate at ParexelClinical Research Associate at Parexel
Arunava MajumderArunava Majumder
Associate Director and Country Lead-Clinical Trial Operations at Pi Health Ltd.Associate Director and Country Lead-Clinical Trial Operations at Pi Health Ltd.