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Senior Regional Site Manager Resume Example

Resume Score: 60%

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SENIOR REGIONAL SITE MANAGER
Professional Summary
Seasoned Clinical Research Professional with diverse project experience from concept to development in the pharmaceutical and biotechnology setting. Talents include in-depth knowledge of ICH Guidelines, SAE reporting, GCP Auditing, Study Start-Up, and Risk-Based Monitoring (RBM) acquired from hands-on experience with CRO and direct sponsor clinical trial programs. Integral team-player with excellent written and oral communication skills. 
Skills

Technical Skills:  MS Word, Excel, Outlook, Lync, and PowerPoint; Working Knowledge of Autodesk AutoCAD; Working Knowledge of MATLAB; IBM SPSS; STATISTICA; GRAPHIC STATE; OriginLab; ImageJ; Any-Maze; ARIBA; TIME; Learning Management Systems; WebEx; CONCUR;

Clinical Trial Management Systems (CTMS):  BRAIN; IMPACT Harmony; Forest Laboratories CTMS; iMedidata; Pedagogue; eMVR; EVRETT; IMPACT MySite;

Electronic Data Capture (EDC):  DataLabs; Advantage; iMedNet; INFORM (versions 4.0-6.0); BRAIN; Forest Research Institute (FRI) proprietary EDC; Medidata Rave;


IWRS/IVRS:  ClinPhone; Premier i360; Bioclinica Trident

Additional Skills:  Undergraduate/Graduate-level Teaching Experience; Project Management; Excellent Written and Oral Communicator; Federal/Private Grant and Protocol Writing/Review; Data Production, Representation, and Analysis; Proficient/Avid Biomedical Research Journal Reader

Work History
Senior Regional Site Manager08/2015 to Current
Allergan, Inc. – Field-Based (Houston, Texas)

- Contract Senior Regional Site Manager (RSM) for Allergan and subsidiaries, including   Forest Research Institute (FRI) and Actavis PLC, through Planet Pharma Staffing;

- Demonstrated strong knowledge, understanding, and application of monitoring SOPs   and Good Clinical Practice to ensure protocol and regulatory compliance across   studies and site assignments;

- Employed Risk Based Monitoring (RBM) on a daily basis to assess and improve site   performance and minimize key risk indicators per sponsor's SOPs;

- Regionally monitored several clinical trial research sites via Pre-Site Selection Visits   (PSSVs), Site Initiation Visits (SIVs), Interim Monitoring Visits (IMVs), Remote   Monitoring Visits (RMVs), Telephone Contact Reports (TCRs), and Close Out Visits   (COVs);

- Completed detailed monitoring letters and visit reports within sponsor timelines;

- Created, analyzed, and followed up on weekly site-level reports for timely data entry,   source data verification, query resolution, regulatory compliance, and  action item   resolution;

- Ensured proper storage, dispensation, and accountability of investigational products;

- Assessed completeness and accuracy of regulatory binders in addition to   collecting/eFiling sponsor-requested study documents;

- Assisted in sponsor and federal audit responses;

- Interfaced MS Word, Excel, PowerPoint, Outlook, and Lync, to effectively manage and   communicate study outcomes;

- Completed and submitted monthly RSM metric reports to Director of Global   Monitoring Operations for review and approval;

- Ensured compliance with all sponsor-required training;

- Partnered with sites to ensure recruitment goals are met;

- Assisted sites with operational needs, such as vendor activities and site payments;

- Exceeded all departmental metrics and deliverables for the following activities: MVR   submissions, freezing eCRFs, data cleaning, and expense reports;

- Attended and presented during regular regional teleconferences;

- Presented components of Global Monitoring Operations (GMO) Orientation to newly   hired GMO personnel and served as assigned sponsor-assigned mentor to several new   monitors;

- Operated as representative on Allergan projects managed by CROs;

- Reviewed and provided input to protocols, paper Case Report Forms (CRFs), eCRFs   and monitoring plans;






Chief Executive Officer & Founder06/2015 to Current
ALEXIVENT Clinical Solutions, LLC – Houston, TX

- Provided short- and long-term contract clinical trial monitoring services for CRO and sponsor projects;

- Conducted qualification, initiation, interim monitoring, remote monitoring, telephone contacts, and termination visits;

- Staffed clinical sites, CROs, and Sponsors with qualified research personnel to ensure proper study conduct and regulatory authority compliance;  

- Trained entry-level clinical researchers in study monitoring, GCP, SOPs, regulatory binder composition, and protocol compliance for sponsor projects;

- Provided consulting services for clinical LLC formations and Site Management Organizations;



Clinical Research Associate II11/2013 to 06/2015
PAREXEL International

- Monitoring and other study-related activities including GCP, SOP(s), and protocol compliance for sponsor projects;  

- Conducted qualification, initiation, interim monitoring, and termination visits;

- Simultaneously and adequately managed more than 25 clinical trial sites; ·       Completed detailed monitoring letters and visit reports within CRO/sponsor timelines;

- Performed feasibility studies for potential clinical trials;

- Ensured proper storage, dispensation, and accountability of investigational drugs;  

- Assessed accuracy and completeness of sites' regulatory binders in addition to collecting/eFiling study documents upon requested;  

- Responded to sponsor and federal audits;  

- Interfaced MS Word, Excel, PowerPoint, Outlook, Lync, to effectively manage and communicate study outcomes;

- Attended and presented during weekly WebEx conference calls to ensure study teams remained aware of project updates and deliverables;

- Trained new team members on protocol, regulatory binder composition, monitoring tasks, EDC, and CTMS during on-site co-monitoring visits;  

- Ensured compliance with all sponsor- and CRO-required training;  

- Met and exceeded all monitoring and non-monitoring business metrics set forth by CRO and sponsor;


Clinical Research Associate 06/2009 to 10/2013
Baylor College of Medicine – Field-Based (Houston, Texas)

- Monitoring and other study related activities including assurance of adherence to GCPs, SOPs, and study protocols;

- Monitored university affiliated clinical trials at on and off site locations; ·       Performed site selection visits, qualification visits, site initiation visits, interim monitoring visits, and close out visits;  

- Performed feasibility studies for potential clinical trials;

- Ensured proper storage, documentation of use, and dispensation of investigational drugs;

- Responded to institutional and federal audits;  

- Designed and managed projects for new team members, interns, and graduate students;

- Used MS Excel, PowerPoint, and other computational software to create spreadsheets, graphs, presentations, and statistically analyze data to effectively communicate study outcomes;

- Gave weekly PowerPoint and improvised chalk-talk presentations on project progress to team members;  

- Fostered intra- and inter-institutional collaborations between PIs;


Clinical Research Assistant05/2008 to 07/2008
Baylor College of Medicine – Houston, Texas

- Monitored clinical trials to ensure subject safety and compliance with the study protocol, FDA regulations, and ICH/GCP Guidelines;

- Coordinated necessary activities required to set-up, monitor, and close-out clinical trial sites;  

- Worked closely with university and external sites' clinical research coordinators to review and respond to data management inquiries; 


Education
Master of Science: Neuroscience2012Baylor College of Medicine- Houston, Texas
Bachelor of Science: Chemistry2009Morehouse College - Atlanta, Georgia
  • Minor:  Mathematics
  • Honors Graduate:  Cum Laude
Training

Good Clinical Practices                                                                        Code of Business Conduct and Ethics ICH Guidelines Drug Accountability   Protocol Deviations Management and Reporting Corrective Action Preventative Action (CAPA)    Protection of Confidential Business Information Personal Identifying Information (PII) HIPPA Guidelines                                                                    Project Team Member Handover FDA Code of Federal Regulations                                                                       DEA Guidelines Federal and Private Grant Writing/Review/Submission                   IACUC Guidelines

Academic & Professional Honors

  ·       McNair Scholar                                                                     ·    University of California–Davis/Santa Barbara   ·       NASA Scholar                                                                                 Summer Institute in Cognitive Neuroscience   ·       Morehouse College Academic Scholarship                                                  Fellowship                                         ·       North Houston Frontier's Club Scholarship                            ·    UTMB Frances Adoue Lynch Addiction           ·       U.S. Department of Energy Scholarship                                          Research Endowment Award                         ·       NSBE Scholarship                                                                ·    Morehouse College Department of Biology     ·       U.S. Department of Energy Outstanding Scholar Award                 Seminar Series, Invited Alumni Speaker         ·       Morehouse College Honor Roll and Dean's List                    ·    NASA Johnson Space Center - Intern             ·       Morehouse College Department of Mathematics Awards            Technical Writing Competition, 1st                 ·       Ruth L. Kirschstein National Research Services Award (NRSA)                                                       Place WinnerF31 Individual Pre-Doctoral Grant, Awardee – NIH National Institute for Drug Abuse (declined)

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Resume Overview

Companies Worked For:

  • Allergan, Inc.
  • ALEXIVENT Clinical Solutions, LLC
  • PAREXEL International
  • Baylor College of Medicine

School Attended

  • Baylor College of Medicine
  • Morehouse College

Job Titles Held:

  • Senior Regional Site Manager
  • Chief Executive Officer & Founder
  • Clinical Research Associate II
  • Clinical Research Associate
  • Clinical Research Assistant

Degrees

  • Master of Science : Neuroscience 2012
    Bachelor of Science : Chemistry 2009

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