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clinical trial manager resume example with 11+ years of experience

Jessica Claire
  • , , 609 Johnson Ave., 49204, Tulsa, OK 100 Montgomery St. 10th Floor
  • H: (555) 432-1000
  • C:
  • resumesample@example.com
  • Date of Birth:
  • India:
  • :
  • single:
  • :
Professional Summary

Experienced Clinical Trial Manager specializing in establishing project objectives, developing experimental plan and effectively prioritizing tasks to meet time sensitive delivery clinical trial milestones and timelines

Skills
  • 10 Years of clinical research experience.
  • Excellent written, verbal, and interpersonal communication skills.
  • Ability to collaborate coherently with clients and site personnel.
  • Experience working in phases I- III clinical trials.
  • Ability to work independently and with cross functional teams.
  • Proficient in developing trial plans including site monitoring plans, risk mitigation strategies, site selection, and
  • Clinical supplies management
  • Superior analytical and creative thinking skills.
  • Strong knowledge of clinical trial monitoring, regulatory compliance, clinical research methodology and all
  • Applicable regulations and guideline.
  • Ability to deal with time demands, incomplete information or unexpected event.
Work History
Clinical Trial Manager, 01/2018 - Current
Planet Pharma , , Houston, TX
  • Closely collaborates with cross function team leads to streamline study management equipment and processes
  • Serves as lead in the development of study pivotal strategy( strategies to increase subject enrollment, vendor management)
  • Provides leadership to clinical site management team members from study start through to closure Serves as Site Management (SM) primary point of contact for clinical monitoring and site activities within the project
  • Hosts Internal and External study team calls
  • Assist with project specific Audits / Inspections
  • Oversees compliance to the CMP, including site visits, outstanding trip reports and visit follow up letters
  • Oversees TMF (Trial Management File) compliance of site management documents Reviews/finalizes trip reports according to Gilead SOPs and expectations
  • May perform site qualification, initiation, interim monitoring, and/or close out site visits as needed
  • Serves as first line issue escalation regarding monitoring and site issues, providing proposed solutions to the project management team and sponsor
  • Participates in study strategy development, Line
  • Listing Review, and Clinical Study Report preparation, as appropriate
  • Manages the study project plan, including timelines and budget
  • Participates in study strategy development, Line
  • Listing Review, and Clinical Study Report preparation, as appropriate
  • Manages the study project plan, including timelines and budget
  • Provides training and manages CRO partner, and third party vendors such as IVRS, Central lab, and Specialty Labs.
Senior Clinical Research Associate, 02/2016 - 01/2018
Ockham , , Houston, TX

•Provides support to the Project Team and Clinical Operations Team

• Maintains strong working knowledge of protocols and Monitoring Plans for assigned projects

• Demonstrates strong written and verbal communication skills

• Serves as primary contact for assigned research sites Verifies that the investigator, staff, and site facilities remain adequate throughout the trial period

• Responsible for the scheduling and conduct of pre-study visits, initiation visits, interim monitoring visits and close-out visits according to the Monitoring Plan

• Ensures research sites conduct studies according to protocol requirements or investigational plan and applicable regulations and guidelines

• Ensures the rights and well-being of human subjects are protected, the reported trial data are accurate, complete, and verifiable from source documents

• Verifies the rights and well-being of trial subjects are protected

• Reconciles site regulatory binder assuring collection and completeness of regulatory documents

• Collects and ensures completeness of all essential regulatory documentation from sites from study startup through closeout

• Verifies that written informed consent was obtained before each subject's participation in the trial

• Verifies that the investigator is enrolling only eligible subjects Performs source data verification against Case Report Form/Electronic Data Capture entries in compliance with the Monitoring Plan

• Ensures accurate and complete data and that corrections are appropriately documented by authorized site staff.

Clinical Research Associate II, 01/2014 - 02/2016
Drug Information Association Inc , ,
  • Works with Sponsor to develop and revise study specific plans and detailed timelines and ensure that transferred obligations and performance expectations are met
  • Proactively identifies potential study issues/risks and recommends/implements solutions
  • Participates in the selection, training and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function
  • Provides support to the Project Team and Clinical Operations
  • Team
  • Maintains strong working knowledge of protocols and
  • Monitoring Plans for assigned projects
  • Demonstrates strong written and verbal communication skills
  • Serves as primary contact for assigned research sites
  • Verifies that the investigator, staff, and site facilities remain adequate throughout the trial period
  • Responsible for the scheduling and conduct of pre-study visits, initiation visits, interim monitoring visits and close-out visits according to the Monitoring Plan
  • Ensures research sites conduct studies according to protocol requirements or investigational plan and applicable regulations and guidelines
  • Ensures the rights and well-being of human subjects are protected, the reported trial data are accurate, complete, and verifiable from source documents
  • Verifies the rights and well-being of trial subjects are protected
  • Reconciles site regulatory binder assuring collection and completeness of regulatory documents
  • Collects and ensures completeness of all essential regulatory documentation from sites from study startup through close- out
  • Verifies that written informed consent was obtained before each subject's participation in the trial
  • Verifies that the investigator is enrolling only eligible subjects
  • Performs source data verification against Case Report
  • Form/Electronic Data Capture entries in compliance with the
  • Monitoring Plan
  • Ensures accurate and complete data and that corrections are appropriately documented by authorized site staff.
Clinical Research Associate, 04/2011 - 01/2014
Arthrex, Inc. , ,
  • Served as an ambassador for research studies so that subjects find our enrollment and informed consent process welcoming, manageable and accessible
  • Conducted review of documentation needed for internal and external audits to ensure all essential clinical trial master file documents are compliant with CP, IQVIA and US regulations
  • Conducted site initiation visits
  • Conducted site monitoring visits and follow-up to identify significant problems and issues and to ensure that all clinical aspects of studies are being carried out in accordance with the study
  • Ensured compliance with terms and conditions
  • Trained site personnel according to Good Clinical Practices and the Code of Federal Regulations
  • Managed assigned clinical sites, partnering with field monitors and site staff to identify and escalate or resolve compliance issues, and escalation of site questions or needs
  • Supervised the conduct of clinical studies in the field
  • Acted as a liaison between site personnel and the sponsor
  • Performed monitoring visits
  • Ensured compliance with protocols, regulatory requirements, and good clinical practices
  • Protected study results by carefully obtaining and documenting subjects' informed consent
  • Participated in assessing study risks
  • Communicated on behalf of the study manager with investigators and site staff
  • Prepared study performance reports and provided input into study budgets
  • Managed study supply inventory and shipping
  • Conducted and assessed site readiness and assisted in creating site monitoring plans
  • Worked across multiple project teams, indications, and different study designs
  • Assisted in the creation of study materials (CRFS, operation manuals, protocols, etc.)
  • Assisted in the creation of departmental operating procedures and tracking systems
  • Facilitated data collection and study execution in collaboration with other research staff.
Education
Bachelor Of Science: Accounting, Expected in
-
University of Houston - Houston, TX
GPA:
Status -

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Resume Overview

School Attended

  • University of Houston

Job Titles Held:

  • Clinical Trial Manager
  • Senior Clinical Research Associate
  • Clinical Research Associate II
  • Clinical Research Associate

Degrees

  • Bachelor Of Science

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