Randall Vaught
Blue Bell,United States of America
Summary
With a robust background in clinical operations and a track record of strategic leadership at ICON, I excel in protocol development and fostering investigator relations. Demonstrated success in enhancing patient recruitment and audit preparation, my approach combines decisive leadership with a keen focus on achieving and surpassing project goals.
Overview
31
31
years of professional experience
Work History
Director of Clinical Operations, Global Lead
ICON
Bristol, TN
04.2022 - Current
- Serves as the primary business point of contact.
- Serve as primary contact for client on Procurement/Sourcing topics
- Serve as primary escalation for client on delivery of Service/Functional Area/Regional topics
- Lead Client Program Governance
- Exec oversight Meetings
- Lead Global/ Regional/ Country Operations Management Meetings Program growth and strategy
- Ensure alignment with client goals and objectives - Operations
- Development and maintenance of Relationship Management Plan (or Rules of Engagement) for existing programs and all relevant program documentation (e.g
- RACI, Governance Charter, On/Off-Boarding Plan, Training Plan, Business Continuity Plan, Quality Oversight Plan, etc.)
- Ensure alignment with client goals and objectives - Business
- Identify and lead activities relative to opportunities to expand business within the client
- Manage Proposal Strategy and Development (with client and internal)
- Develop financial terms and rates in alignment with gross margin expectations (internal)
- Negotiate financial terms and rates in alignment with gross margin expectations (with client)
- Manage process for initial creation and updates to MSA/Contract/Task Order/Work Order
- Support proposals and operations as required with country intelligence data
- Direct / oversee non-program related activities of operations
- Manage overall ISS standard / MBO metrics and initiatives relative to innovations and efficiencies
- Make decision to add / hire/ promote/ remove non billable resources to a team
- Interviewing candidates and approving placement
- Establish and manage program level metrics/KPIs and initiatives relative to innovations and efficiencies
- Establish and manage ISS functional deliverable level metrics/KPIs and initiatives relative to innovations and efficiencies
- Establish and manage program level functional deliverable quality oversight plan including tools & processes
- Review individual contributor and team level functional metrics and oversee action plans to resolve issues
- Serve as People Leader for Assigned Staff, including Regional Leads
Associate Director - Americas Regional Lead
ICON
Charlottesville, United States of America
09.2020 - 03.2022
- Company Overview: formerly PRA Health Sciences
- Implements direction, strategy and performance standards for multiple job disciplines to assure that project profitability targets are achieved
- Mentors and develops employees to expand employee performance levels and assure retention of high performing employees
- Ensures appropriate employee resources are available to meeting corporate / client / project objectives while achieving optimal billability of clinical operations staff
- Participates in PRA's Quality Process Management improvements by assuring quality metrics align with company, client and clinical operations objectives
- Hold Americas Resource Meeting with Client
- Manage TA open requisition activities for the Americas
- Formerly PRA Health Sciences
Manager of Operations, Strategic Solutions Division
ICON
Charlottesville, United States of America
04.2018 - 09.2020
- Company Overview: formerly PRA Health Sciences
- Serve as Line Manager for COSLs (PM II) for embedded program
- Serve as Line Manager for various other work groups as directed for the embedded program
- Develop plans to support growth and career Development of assigned Clinical Operations employees
- Manage the delivery of quality performance in line with their job description
- Ensures staff development and performance feedback are provided through activities such as mentor-ship and career development
- Communicated team and individual goals and expectations to ensure direct reports understand their responsibilities
- Responsible for managing the performance of staff, including providing input into salaries, bonuses as well as nominations for promotion
- Promotes a positive and professional work environment that attracts and retains the best talent and delivers services that exceed customer expectations
- Responsible for the management of resources and resource projections to ensure project teams are consistent
- Serve as Manager of the FSP Peer Buddy Program (Worldwide)
- Serve as Line Manager for Associate COPLs (Associate Director)
- Serve as Line Manager for CTAs (In-House CRA)
- Served as Interim Line Manager for SAMs and Lead SAMs (Study Start-Up Manager)
- Formerly PRA Health Sciences
Senior Manager Clinical Operations
Parexel
Billerica, United States of America
05.2012 - 03.2018
- Managed and oversaw On Site Monitors activities including appropriate resourcing of staff, staff assignments, quality control of project deliverable and timely delivery of project deliverable
- Manage and oversee Managers, Clinical Operations (Line Management)
- Serve as COM - overseeing total project deliverables including COL (CTM) oversight, SSU oversight, and overall program directives and budgets
- Maintain level of productivity/bill-ability and staff turnover
- Participate in and contribute to Project bids, including client presentations
- Ensure direct reports meeting departmental and project productivity and quality metrics
- Produce resourcing plans
- Facilitate metrics collection and develop action plans
- Provide technical support to team members
- Develop Mentor Program for new hire CRAs and Line Managers for assigned program
- Maintained the highest team retention rate for 3 years straight
- Served as the Clinical Operations RFP reviewer and trainer
- Won Service Award for Line Management Effectiveness twice
Manager of Clinical Operations
PRA Health Sciences
Fort Washington, United States of America
10.2009 - 04.2012
- Company Overview: formerly ReSearch Pharmaceutical Services (RPS)
- Manage and Evaluate Regional CRAs, Assistant CRA Managers, Lead CRAs, Pharmacy Monitors, EU Monitors, and Monitoring Report Reviewers
- Complete performance Assessment Visits
- Approve expenses and travel schedules for CRAs
- Approve time sheets and expenses for staff
- Work as Liaison for CRAs and Project Management team
- Manage CRA deliverables and timelines
- Hold weekly meetings with CRAs, Associate Line Managers, and Project Management team
- Track CRF review
- Train and mentor new CRA Managers
- Responsible for planning, assigning, and directing work
- Appraising performance and guiding professional development
- Identify quality risks and issues and create appropriate corrective action plans to correct deficiencies in performance of staff
- Formerly ReSearch Pharmaceutical Services (RPS)
Operations Manager
MRA
New York, United States of America
06.2008 - 10.2009
- Manage and evaluate CRAs, Lead CRAs, and Project Managers
- Approve expenses and travel schedule for CRAs
- Complete performance Assessment Visits for CRAs, and work assessments for non-traveling staff
- Review and approve Monitoring Reports and provide QC review for PM reviews
- Manage staff deliverables and timelines
- Train and mentor new Operation Managers
- Responsible for planning, assigning, and directing work
- Appraising performance and guiding professional development
- Identify quality risks and issues and create appropriate corrective action plans to correct deficiencies in performance of staff
- Selected to perform all clinical lay-offs for company
- Started first training program for CRAs and Project Managers for CRO
- Identified as Clinical Research Manager that worked closely with HR and performed lay-offs for entire Clinical Operations staff at CRO closure
Contracting Manager
ISTA PHARMA
San Diego, United States of America
03.2006 - 05.2008
- Manage Contract CRAs to include review of time sheets, expenses, monitoring reports, and day to day deliverables
- Co-monitored Contract CRAs and evaluate performance for sponsor
Director of Project Management
CTMS, Inc.
Bristol, United States of America
05.1999 - 02.2006
- Manage and evaluate staff and support staff to include Clinical, Data Management, Regulatory, Finance, Recruitment and Contracts
- Manage Vendors, Data Management, Regulatory and Recruitment
- Served as liaison and contact for sponsor, vendors, QA, DM, CRAs, and support staff
- Manage day to day activities of clinical trials
- Oversee day to day activities of Project Managers assigned to projects under my direction
- Prepare and arrange for education and training of staff
- Assist in the training and coaching of new Project Managers
- Planned and presented at Investigator Meetings
- Clin-Ops RFP representative
- Present in Bid-Defense meetings
Project Manager
CTMS, Inc.
Bristol, United States of America
05.1997 - 05.1999
Clinical Research Associate
CTMS, Inc.
Bristol, United States of America
05.1994 - 05.1997
- Perform Site Qualification, Initiation, Interim and Termination Visits
- Responsible for Site Management to include site start up activities, IRB approval review, document review, first line of contact for site, and issue resolution
- Complete all required site visit documentation to include Monitoring Report, Conformation and FU letters
- Responsible for Drug accountability and return
Education
BA - Medical Social Work
Virginia Intermont College
Bristol, VA, United States of America05.1989
Diploma -
Johnson County High School
Mountain City, TN, United States of America05.1985
Skills
- Protocol development
- Patient recruitment
- Investigator relations
- Audit preparation
- Site selection
- Clinical research
Therapeutic Experience
- Gastroenterology, Esophageal, GERD, Clinical, 1, 3 yrs, 0 mos, III, ADULTS
- Neurology, Mental Disorders, Neurotic Disorders, Project Manager, 1, 6 yrs, 9 mos, II, ADULTS
- Oncology, Solid Tumors, Breast, Project Manager, 1, 2 yrs, 0 mos, II
- Respiratory, Asthma, Mod/Severe Asthma, Project Manager, 1, 6 yrs, 9 mos, III, COPD Subjects; ADULTS
Geographic Experience
- ARGENTINA, Neurology, Project Manager
- BRAZIL, Neurology, Project Manager
- COSTA RICA, Neurology, Project Manager
- UNITED STATES, Gastroenterology, Oncology, Respiratory, Clinical Research Associate, Project Manager
Drug Type Experience
- Chemical Entity (Sch 2), Neurology, Respiratory, ADULTS, COPD Subjects; ADULTS
- Device, Oncology
- Diagnostic, Gastroenterology, ADULTS
Environment Experience
- Doctor's Office, Gastroenterology, Respiratory, ADULTS, COPD Subjects; ADULTS
- Out-patient, Gastroenterology, Neurology, ADULTS
System Experience
- Clinical Trial Management Systems, Client Proprietary System, Elara (Pfizer), IMPACT CTMS, ISS Sponsor CTMS, Medidata CTMS
- CRF Design (paper), Teleform
- EDC, Oracle Clinical - RDC, Oracle Inform, Veeva Vault EDC
- IVRS/IWRS/RTSM, Datalabs IVRS
- TMF, Documentum ETMF
Vendor Experience
- Drug Packaging & Distribution, Pfizer
- IRB, WIRB
Degree
BA
Field
Medical Social Work
Personal Information
Title: Director, of Clinical Operations I
Languages
English, High, High, High, High
Cv Confirmation
Randall Vaught, 02/25/25
Generated On
02/25/25
Websites
Timeline
Director of Clinical Operations, Global Lead
ICON
04.2022 - Current
Associate Director - Americas Regional Lead
ICON
09.2020 - 03.2022
Manager of Operations, Strategic Solutions Division
ICON
04.2018 - 09.2020
Senior Manager Clinical Operations
Parexel
05.2012 - 03.2018
Manager of Clinical Operations
PRA Health Sciences
10.2009 - 04.2012
Operations Manager
MRA
06.2008 - 10.2009
Contracting Manager
ISTA PHARMA
03.2006 - 05.2008
Director of Project Management
CTMS, Inc.
05.1999 - 02.2006
Project Manager
CTMS, Inc.
05.1997 - 05.1999
Clinical Research Associate
CTMS, Inc.
05.1994 - 05.1997
BA - Medical Social Work
Virginia Intermont College
Diploma -
Johnson County High School
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