Susan Darden

Susan darden

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location of Susan DardenAthens, Georgia, United States
Followers of Susan Darden249 followers
  • Timeline

  • About me

    Senior Clinical Research Associate, Georgia Clinical Operations at Boehringer Ingelheim Animal Health USA

  • Education

    • University of georgia - franklin college of arts and sciences

      1986 - 1991
      Bachelor of arts (b.a.) english
  • Experience

    • Law office of william c. bushnell

      Sept 1997 - Dec 1998
      Legal assistant

      Assisted attorney in general practice, which included estate planning, civil litigation, personal injury, and criminal defense. Main duties included drafting and filing pleadings, discovery, and probate documents; maintaining client contact; docketing court appearances; organizing case files; preparing settlement packages.

    • Fortson bentley & griffin

      Jan 1999 - Dec 2000
      Legal assistant

      Assisted attorney in busy law firm specializing in insurance defense and general civil litigation. Main duties included drafting correspondence, pleadings, and discovery; filing pleadings with appropriate court; coordinating depositions and mediation sessions; communicating with clients; docketing court appearances; billing.

    • Merial limited

      Jan 2001 - Mar 2007

      Responsible for preparing documentation necessary to conduct veterinary scientific studies for pharmaceutical and biological products. Responsible for drafting research contracts and ensuring that timely milestone payments are made to research partners and service suppliers. Analyzed proposed study budgets to develop detailed contract terms. Functioned as a department liaison for contract investigators located in both private and university settings. Duties also included proofreading, editing and formatting study protocols and reports drafted by staff scientists. Served as Archivist for biological research and development. Show less Duties included serving as a company link between vendors, research institutions, universities, industrial partners and in-house attorneys in order to prepare and execute agreements; drafting consulting services contracts, confidential disclosure agreements, and supply and distribution agreements for industry use; tracking agreements though the development process; establishing and maintaining contract archives, computerized contract database and trademark files; performing research on industry topics to support projects assigned to the Legal Department. Show less

      • Clinical Trial Specialist

        Apr 2002 - Mar 2007
      • Legal Assistant

        Jan 2001 - Apr 2002
    • Merial, a sanofi company

      Apr 2007 - Nov 2016

      As part of the team charged with upgrading Merial R&D’s project and resource planning system to Planisware 6 technology, I was responsible for collecting user requirements, performing system testing and feedback to developers (including writing all test scripts), designing training documentation and delivering training to users across the globe. After system go-live, I was responsible for the administration of the system (called internally, Horizon) which included adding new users to the system, performing quality checks of new project timelines added to the system, implementing changes and improvements to the system, delivering training to new users and responding to all helpdesk tickets for the system. Show less Responsible for working with clinical personnel to develop project plans, tasks and FTE resource requirements necessary to conduct pharmaceutical and biological research and development studies. Tracked key performance indicators (KPIs) for the Clinical R&D group and prepared KPI reports for R&D management. Served as member of the Resman team assigned with the development, customization and implementation of a new R&D resource and planning management tool, as well as working with the program testing, creation of SOPs and training of end users. Duties also included working with Veterinary Scientists, R&D Leaders and Project Planners to ensure alignment of resources with timelines for R&D projects; working with other Functional Planners within R&D to identify potential project constraints and developing strategies for alleviating those constraints; coordinating and processing all research contracts with contract labs and serving as a liaison between Finance, Procurement and R&D in the execution of research contracts; supported clinical leaders by projecting budgetary costs for projects, managing costs and tracking project expenses. Show less

      • System Administrator

        Apr 2011 - Nov 2016
      • Functional Planner

        Apr 2007 - Mar 2011
    • Boehringer ingelheim

      Nov 2016 - now

      Responsible for the execution of Clinical R&D study programs in alignment with Clinical Scientists. Provides key direction in the initiation, organization, conduct and reporting of on-site and off-site (national and global) clinical studies for all animal species. Interfaces with Clinical Research Organizations and Investigators to monitor study status, maintain quality control and integrity of data, and manage study data and procedures in compliance with GxP and relevant regulatory guidelines. Additionally, draft study documents and reports, assist with study in-life phase, design and implement study related processes and be responsible for the closure of studies including preparation for archiving. Coordinate submission preparation activities, specifically: Participate in the Clinical Operations submissions sub-team in the preparation of data portions of dossiers to be submitted to regulatory authorities and collaborate effectively with Regulatory Affairs to align on document organization. Show less

      • Senior Clinical Research Associate, Georgia Clinical Operations

        Jun 2021 - now
      • Senior Specialist, Clinical Research

        May 2019 - Jun 2021
      • Clinical Research Associate

        Nov 2016 - May 2019
  • Licenses & Certifications

    • Certified project management professional

      Project management institute