Loren VanPelt
Pipersville,PA
Summary
Strong leader and problem-solver dedicated to streamlining operations to decrease costs and promote organizational efficiency. Strengths in building relationships with a diverse range of stakeholders in dynamic, fast-paced settings.
Overview
17
17
years of professional experience
Work History
Operations Portfolio Lead
Bristol-Myers Squibb (BMS)
09.2020 - Current
- Provides operational oversight of Late Development Cardiovascular Book of Work of approximately 80 studies
- Accountable for study execution, managing budget and quality parameters
- Knowledge in feasibility assessments, including protocol design, site/country feasibility and enrollment projections
- Identifies and manages risk and issue escalation across portfolio
- Communicates program status updates to cross functional leadership across matrix organization
- Strategically access study and program metrics to ensure appropriate methods are implemented to lead to project success
- Provides operational decisions related to vendor and CRO selection
- Acts as primary escalation point for all operational issues.
- Successfully managed crisis situations maintaining focus on priorities while providing guidance for rapid resolution.
Global Trial Manager
Bristol-Myers Squibb Company
07.2018 - 08.2020
- Lead successful and timely operational execution of ISR clinical trial from concept to study closure
- Facilitated identification and prompt escalation of project risks and issues along with mitigation/ resolution strategies to appropriate stakeholders to expedite resolution
- Primary operational contact for clinical trials including ISR issue resolution and stakeholder management
- Lead and facilitated study team meetings to review for operationally delayed studies, identifying source of delays and issues and escalation as appropriate
- Managed new concept submission facilitating medical and governance review
- Monitored study budget and maintained close communication with finance and medical team by co-leading Reporting, Executing and Finance Meetings (REF) held monthly
- Expertise with clinical trial management systems to track metrics, timelines, and other data to ensure Protocol and/or Program quality timelines and budget are managed according to expectations
- Built strong relationships and encouraged collaboration with team members and internal and external stakeholders across organizational, functional, and geographic boundaries to achieve project and/or program deliverables
- Oversight of large portfolio, including global Book of Work of 119 Studies.
- Maximized performance by monitoring daily activities and mentoring team members.
Clinical Study Manager
Syneos Health
03.2017 - 07.2018
- Experience in all aspects of study start-up and maintenance, regulatory obligations, adverse event reporting, budget awareness, and working with Contract Research Organizations (CROs), or external vendors (IVRS/IXRS)
- Project planning and prioritization, timeline management, time and meeting management skills, and ability to identify and manage or escalate risks
- Formed positive working relationships with stakeholders and effectively management ability; effectively communicate and aligns with other departments; contributes to cross-functional teams, task forces, or local and global initiatives
- Understanding of ICH/GCP Guidelines and local regulatory guidelines/ regulations
Clinical Research Associate
Bioclinica Post Approval Services
08.2015 - 03.2017
- Performed routine site monitoring calls to ensure protocol, regulatory, and GCP compliance
- Review Case Report Forms for completeness and safety triggers
- Collect, track, and review required regulatory documents
- Prepare and submit ongoing regulatory documents to central and other local regulatory authorities to ensure compliance
- Complete Quality Control review of regulatory files and site specific Trial Master File
- Submit investigator grant payments and additional vendor payments.
Clinical Research Coordinator
Deborah Heart and Lung Center
08.2012 - 08.2015
- Responsible for screening of patients, consenting, collecting patient data, and proper patient compliance within study
- Complete Case Report Forms for each trial participant and document medical data in subject study chart
- Appropriately document adverse events to sponsor and IRB
- Maintain accurate and complete trial binder and records
- Receive, inventory, return and destroy investigational product
- Adherence to protocol, GCP, applicable regulations and trial related documents.
Scheduling Representative
Deborah Heart and Lung Center
04.2011 - 08.2012
- Scheduling capabilities related to all areas of outpatient clinic with focus on vascular surgery scheduling
- Primary contact for research coordinators regarding scheduling follow up appointments for patients participating in clinical trials.
- Provided exceptional customer service while addressing inquiries related to appointments, rescheduling requests, or general information on services offered.
Physician Relations Coordinator
Kingley Institute
08.2007 - 10.2008
- Primary contact for all physicians and healthcare companies within company
- Managed all physician related responsibilities related to fitness, nutrition, and behavioral counseling services
- Updated physicians on status of their patients.
Education
Bachelor of Science - Exercise Physiology
West Virginia University, School of Medicine
Morgantown08.2007
Skills
- Operational Efficiency
- Teamwork and Collaboration
- Decision-Making
- Effective leader
- Operations Oversight
- KPI Tracking
- Project Planning
- KPI Tracking
- Project Planning
Timeline
Operations Portfolio Lead
Bristol-Myers Squibb (BMS)
09.2020 - Current
Global Trial Manager
Bristol-Myers Squibb Company
07.2018 - 08.2020
Clinical Study Manager
Syneos Health
03.2017 - 07.2018
Clinical Research Associate
Bioclinica Post Approval Services
08.2015 - 03.2017
Clinical Research Coordinator
Deborah Heart and Lung Center
08.2012 - 08.2015
Scheduling Representative
Deborah Heart and Lung Center
04.2011 - 08.2012
Physician Relations Coordinator
Kingley Institute
08.2007 - 10.2008
Bachelor of Science - Exercise Physiology
West Virginia University, School of Medicine
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