Summary
Work History
Education
Skills
Certification
Timeline
Generic

Wubet Redda

Coppell,TX

Summary

Versatile clinical research leader with strong clinical research knowledge and experience managing complex Oncology clinical trials from Phase I to Phase IV and across various therapeutic areas. Highly organized and thorough with good planning, problem-solving and abilities to handle multiple projects simultaneously with a high degree of accuracy.

Work History

Clinical Program Lead and Site Relations Manager

Anova Enterprises, Inc.
02.2021 - 02.2023
  • Collaborated closely with Anova's Senior Leadership Team to drive business development, manage leads, control costs to increase profits and implement growth campaigns.
  • Successfully managed several research trials, AnovaOS product launch and site development projects and ensured clinical trial activities and deliverables are completed on time, within budget, and meet quality standards
  • Developed and reviewed trial-specific documents (e.g., Protocols, Subject Information Leaflet/Informed Consent Forms, Laboratory Manual, Pharmacy Manual) for Sponsors
  • For studies managed by Anova: assisted in the preparation and conduct of Kick-Off Meetings, Investigators' meetings and other meetings with Key Opinion Leaders
  • Managed relationships with sponsors, CROs, research sites, community practices, and vendors/suppliers
  • Managed several Clinical Projects including overseeing operational aspects of assigned clinical trials from study start-up to maintenance and closeout.
  • Developed and maintained SOPs, tools, and study-related documents, emphasizing quality and compliance in clinical trial management.
  • Provided senior management and clients with comprehensive reports and updates on site relationships, project progress, and key performance metrics, offering transparency and actionable insights.

Lead Site Manager/ Lead Clinical Research Associate

IQVIA/ Previously Quintiles IMS
12.2015 - 02.2021
  • Managed the progress of clinical studies, patient recruitment, and data monitoring efforts to ensure study compliance, timelines and milestones are met
  • Monitored trial systems (CTMS, eTMF, CRF, IRS, central lab portal, etc.) and provided updates on regular basis to ensures systems reports are up to date and reports generated are current and correct.
  • Coordinated and led regular project team meetings, developed study tools and provided protocol refresher trainings to ensure all CRAs are informed and aligned
  • Conducted Accompanied Site Visits on behalf of Direct Line Managers, reviewed monitoring reports and follow up letters and provided essential coaching and constructive feedback to junior CRAs
  • Mentored and trained new CRAs during their onboarding phase as a Subject Matter Expert (SME) in Sponsor & Quintiles systems.

Regional Clinical Research Associate (RCRA) - Oncology

Theorem Clinical Research- CRO
05.2014 - 12.2015
  • Managed the progress of Oncology clinical studies at investigator sites and conducted onsite and remote monitoring visits
  • Performed comprehensive site management activities, trained site personnel on study protocol and regulatory requirements and supported them in the evaluation and recruitment processes.
  • Served as a liaison between the sponsor and the trial sites and ensured sites meet study requirements, enrollment goals and help identify and rectify any deficiencies.
  • Conducted pre-study site qualification visits on behalf of Project managers and Fit for Purpose Sponsor Audit visits in strict accordance with contracted scope of work and good clinical practice (GCP).
  • Maintained strict adherence to study timelines and budgets while consistently delivering timely and comprehensive visit status reports and telephone reports.

Lead CRA/ Sr. Clinical Research Associate

St. Jude Medical- Neuromodulation Division
11.2012 - 05.2014
  • Led study start-up activities including study document preparation and site identification. Assisted Sr. Project Manager with preparing and reviewing study documents (protocol, ICF, CRFs, operation manuals, study aids) for FDA submission and ethics committee/ IRB approval.
  • Collaborated closely with the Senior Project Manager to streamline project delivery, tracked and maintained study budget including monitoring expenses, site payments and helped control costs within the projects.
  • Identified potential investigator sites and conducted Pre-study Qualification visits. Reviewed study plans with clinical investigators to ensure alignment with study parameters and regulatory guidelines.
  • Tracked and maintained Investigational device supply throughout the studies and followed up on device related issues reported in the studies.
  • Managed study progress and maintained Clinical trial management trackers and databases, provided crucial support in Adverse Event adjudication and reconciliation
  • Provided regular updates to research team and research sites on project progress, milestones, protocol amendments and addressed any issues or concerns that arise.
  • Conduct periodic audits to ensure the quality and compliance of clinical trial data and regulatory files and help identify and rectify any deficiencies.

Clinical Research Associate

St. Jude Medical- Neuromodulation Division
08.2010 - 10.2012
  • Conducted monitoring visits remote and onsite to ensure site's compliance to study Protocols, FDA regulations, ICH-GCP guidelines, ethics committees, and SOPs.
  • Trained site staff on protocol requirements and GCP guidelines to ensure proper conduct of the study.
  • Ensured the completion/ collection of Adverse Events (AEs), Serious Adverse Events (SAEs) and timely report of all safety reports to Sponsors, regulatory and ethics committees.
  • Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
  • Adhered to procedures, practices and regulatory requirements to maintain health, safety and environmental compliance.

Associate Manager/ Oncology Project Coordinator

Mary Crowley Cancer Research Centers
01.2009 - 08.2010
  • In collaboration with senior project managers, provided project management support for all the sites managed by the Site Management Organization (SMO)
  • Managed regulatory and safety submission, patient screening & enrollment activities, data management, and the overall coordination of research activities at the sites.
  • Ensured timely distribution of information from sponsors to network of sites including ongoing Oncology trial communications, Amendments and updated study documents.
  • Oversaw Monitoring visits and conducted exit interviews with sponsor CRAs/ Auditors to address any discrepancies noted during monitoring visits.
  • Coordinated with satellite sites to resolve database queries and audit findings.

Oncology Regulatory Affairs Specialist

Mary Crowley Cancer Research Centers
03.2008 - 01.2009
  • Provided regulatory and safety support for network of sites participating in 5-7 Oncology Phase I-III clinical studies for different cancer types including Ovarian, Colorectal, Pancreatic, Head and Neck and Solid tumor.
  • Maintained regulatory records accurate, detailed and fully compliant with reporting requirements to meet local, and federal requirements.

Oncology Research Data Coordinator II

Mary Crowley Cancer Research Centers
11.2006 - 03.2008
  • Accurately entered and maintained data in databases, spreadsheets, and electronic Case Report Forms (eCRFs) for network of sites across 5-7 Oncology studies sponsored by different companies and for cancer types such as Melanoma, Breast, Lung, Prostate, Colorectal etc.

Clinical Research Technician

RCTS, Inc.
12.2005 - 10.2006
  • Coordinated all aspects of clinical trials, from initial planning to closeout
  • Evaluated participants, obtained informed consents, enrolled participants in research studies and collected data per study protocol and SOPs.
  • Designed, constructed and implemented research proposals, protocols and procedures.
  • Assisted with analysis of research data in collaboration with research department.

Education

Bachelor of Science in Biology -

University of Texas at Arlington
05.2005

Skills

  • Clinical Operations
  • Protocol Development
  • Cross-functional Collaboration
  • Budget Management
  • Vendor Management
  • Training and Mentoring
  • Data Analysis
  • Monitoring Oversight

Certification

  • CCRA, Association of Certified Research Professional, 09/2012
  • Barnett Accreditation – Expert GCP Exam for Managers and Staff interacting with investigational sites

Timeline

Clinical Program Lead and Site Relations Manager

Anova Enterprises, Inc.
02.2021 - 02.2023

Lead Site Manager/ Lead Clinical Research Associate

IQVIA/ Previously Quintiles IMS
12.2015 - 02.2021

Regional Clinical Research Associate (RCRA) - Oncology

Theorem Clinical Research- CRO
05.2014 - 12.2015

Lead CRA/ Sr. Clinical Research Associate

St. Jude Medical- Neuromodulation Division
11.2012 - 05.2014

Clinical Research Associate

St. Jude Medical- Neuromodulation Division
08.2010 - 10.2012

Associate Manager/ Oncology Project Coordinator

Mary Crowley Cancer Research Centers
01.2009 - 08.2010

Oncology Regulatory Affairs Specialist

Mary Crowley Cancer Research Centers
03.2008 - 01.2009

Oncology Research Data Coordinator II

Mary Crowley Cancer Research Centers
11.2006 - 03.2008

Clinical Research Technician

RCTS, Inc.
12.2005 - 10.2006

Bachelor of Science in Biology -

University of Texas at Arlington

Similar Profiles

CREATE PROFILE
Wubet Redda