Lauren Zalin, CCRA

Experience

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  ZOLL Medical Corporation

  Nov 2010 - Jul 2016

  Oversee the day-to-day management of multiple trials to ensure all trial deliverables are met according to timelines, budget, quality standards and operational best practices; supervises and provides day to day work direction for project specific activities of CRAs; participate in the design and review of clinical protocols, case report forms (CRFs), associated study documents, monitoring plans, and regulatory submissions and reports in collaboration with clinical management; coordinate clinical data monitoring and database activities via a key relationship with project Data Management; serve as an operational resource for internal team members for expedited problem identification and resolution, provision of site-specific updates and investigator activities, and CRO/Vendor interactions and deadlines; ensure adherence to protocols, procedures, and project plans; participate in identification, evaluation, and selection of investigative sites; assists and manage activities and interactions with CROs/Vendors; ability to coordinate and manage multiple projects across multiple centers and countries; coordinates clinical site monitoring activities, and participate in site monitoring associated with initiation, interim, close out, and audit visits as required; conduct motivational visits, as well as, develop materials and initiatives to support patient recruitment and retention with each site; adhere and assists with the development and facilitation of clinical documents including informed consent forms, case report forms, study manuals, Standard Operating Procedures, and other clinical materials to ensure compliance with regulatory, IRB, and company policies; reviews study data and resolution of queries, compile data for data review, create tables and graphs under appropriate guidance, and assist with the preparation and review of clinical study reports, facilitate/prepare technical reports, summaries, and quantitative analyses. Show less

  • Associate Project Manager

    May 2014 - Jul 2016

  • Clinical Research Associate

    Oct 2012 - May 2014

  • Intake Specialist

    Aug 2011 - Oct 2012

  • Authorization Specialist

    Nov 2010 - Aug 2011
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  IQVIA MedTech (Novella Clinical)

  Jul 2016 - Jul 2019

  Project Manager

  Manages projects of full scope regional and global projects; Responsible for project team leadership; Responsible for building and maintaining positive client relationships; Ability to negotiate with clients to assure Novella’s operational processes are maintained, projects are done within scope; Reviewing and identifying project study trends and proactively responding to client and respective team members; Developing appropriate early warning systems of potential obstacles to the successful completion of the projects; analyzes information and develops innovative solutions to challenges; Identifying, define, document training requirements in LMS systems and assure project level compliance with study specific training requirements; Responsible for change management on all assigned projects; Responsible for assuring projects assigned are run according to SOPs and WP as refined in the contract; Responsible for assuring project timelines are met as per contract; Responsible for maintaining client relationships for all assigned work, keeping all project reporting current, and assuring executive management is aware ; Oversee delegation of support staff activities, as necessary; Assists in the development and delivery of capability and proposal defense presentations to prospective clients; Supports Contracts and Proposals with final project contract execution and CIS documentation by the project team. Represents senior management in negotiation of contracts as appropriate; Participates in the performance appraisal program by providing timely and accurate feedback regarding the performance of respective team members at least annually; Maintains current knowledge of FDA regulations, and GCP and ICH Guidelines for clinical research; Responsible to maintain personal currency documentation for Novella SOPs, CAPA completion and timesheet maintenance including assurance or back-up PM staff at each and every instance of out of office Show less

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  Syneos Health

  Jul 2019 - Jul 2021

  Senior Project Manager
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  ICON plc

  Jul 2021 - now

  Program Manager