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ASSISTANT DIRECTOR OF GOVERNMENT SERVICES / AUDIT CO-TASK LEADER Resume Example

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ASSISTANT DIRECTOR OF GOVERNMENT SERVICES / AUDIT CO-TASK LEADER
Professional Overview
Experienced Project Manager with strong oncology clinical research background and excellent communication skills demonstrated by > 15 years experience working within government and industry sponsored trial structures and a CRO environment. Proven record of reliability and strong ability to effectively liaise across pertinent areas of team participation. Detail-oriented with solid organizational skills and proficiency in working independently and within team environments. 
Skill Highlights
  • Strong written and oral communication
  • Effective clinical team and trial management
  • Microsoft Word, Excel and PowerPoint
  • Training and orientation capability
  • Extensive multi-site national trial experience
  • Problem analysis and resolution ability
Project Highlights
  • Coordinated and/or led 12 working groups ensuring the continued trajectory of complex trial development
  • Successfully solicited, tracked and collated nomination materials for > 300 national oncology leaders resulting in the selection of 45 principal investigators for nationwide precision medicine trial
  • Worked with underserved population and patient advocacy committees resulting in successful protocol changes
  • Successfully led office preparation for 3 sponsor audits
  • Co-developed company CRA monitoring plan/procedures, collaborated with CTMB on site audit guidelines
  • Established an electronic filing system for project activities
  • Recognized by NIH for collaborative input to restructure the NCI National Clinical Trials Network
  • Formulated and/or provided input on >20 surveys to ensure study viability and appropriateness
  • Appointed as representative on company committees: Standard Operating Procedures, Employee Recognition
  • Integral team member for Medidata Rave data management system development
Professional Experience
Company NameCity, StateASSISTANT DIRECTOR OF GOVERNMENT SERVICES / AUDIT CO-TASK LEADER08/2011 to 07/2015
  • Senior project management of a national multi-faceted collaborative genomic profile oncology trial
  • Review protocols, case report forms and informed consent for development of new studies
  • Joint oversight of federal audit program to assure clinical trial adherence stipulated by CTMB
  • Augment audit team as a site auditor, when necessary
  • Generation of monthly audit statistic report for all NCI funded trials sponsored by participating CTSU members
  • Coordinate and manage project trial teams including clinical operations, data management, monitoring and regulatory compliance
  • Develop project SOP tracking and timeline adherence
  • Responsible for implementing supplemental accrual efforts; i.e. newsletters, surveys, site correspondence, patient and physician directed information
  • Maintain project status and fiscal reports for all managed studies.
  • Ensured meeting minutes accuracy through precise documentation and electronic file maintenance.
  • Ensured proper confidentiality agreement documentation 
Company NameCity, StateSENIOR PROJECT MANAGER / AUDIT CO-TASK LEADER09/2003 to 08/2011
  • Oversee manual patient randomization process and provide guidance to site participants regarding study eligibility determination
  • Data query resolution process oversight
  • Developed departmental electronic file system
  • Tracking metrics for results
  • Participated in SOP development and ongoing team educational training
  • Ensured efficacy of protocol due diligence through auditor and monitor trip report assessments.
  • Primary contact for routine protocol efforts across departments
  • Manage and identify study appropriate sites through use of performance metrics and feasibility surveys
Company NameCity, StatePROJECT MANAGER05/1999 to 07/2001
  • Effectively manage industry supported projects
  • Monitor the project timeline, budget, and resource allocation.
  • Interact and routinely communicate with Sponsor relative to daily operational issues.
  • Maintain current knowledge of federal regulations pertaining to clinical research in accordance with GCPs and company SOPs.
  • Provide assistance in the development of systems and procedures for the department.
  • Track and analyze performance metrics for projects under responsibility.
  • Manage clinical staff for projects under responsibility and ensure the quality of their work.
  • Review written communication from clinical staff under supervision.
  • Assist with the continued professional development of staff within area of responsibility.
  • Prepare monthly study status reports for company and sponsor SAE tracking and site follow-up.
  • Oversight of all project related duties including: investigative site identification, regulatory document process, monitor visits, case report form and source document input and review, and drug accountability and reconciliation.
Company NameCity, StateSENIOR CLINICAL RESEARCH ASSOCIATE / CLINICAL RESEARCH ASSOCIATE11/1997 to 05/1999
  • Managed Clinical Research Associates for all aspects of monitoring: including monitor report review, co-monitoring of sites, if necessary and point of contact for escalation of identified site problem.
  • Created and maintained monthly study newsletter and pamphlet.
  • Conducted clinical monitoring visits for oncology and other trial types in accordance with company and sponsor SOP's and standard GCPs.
  • Investigative site identification, drug accountability and reconciliation review.
  • Detailed monitoring visit reports generated and maintained within trial master file system.
Education and Training
Bachelor of Arts:Business Administration1991University of Pennsylvania - Wharton School of Business, City, State
Certifications
Society Of Clinical Research Associates Certification  2005 - 2015

REFERENCES
Available Upon Request
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Resume Overview

School Attended

  • University of Pennsylvania - Wharton School of Business

Job Titles Held:

  • ASSISTANT DIRECTOR OF GOVERNMENT SERVICES / AUDIT CO-TASK LEADER
  • SENIOR PROJECT MANAGER / AUDIT CO-TASK LEADER
  • PROJECT MANAGER
  • SENIOR CLINICAL RESEARCH ASSOCIATE / CLINICAL RESEARCH ASSOCIATE

Degrees

  • Bachelor of Arts : Business Administration 1991

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