Gabriel Lerman

Experience

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  Merck

  May 2003 - Sept 2003

  Data Quality Associate
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  Covalent Group

  Sept 2003 - Apr 2004

  Clinical Data Coordinator
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  Wyeth

  Apr 2004 - Jul 2007

  ▪ Led and oversaw the execution of clinical trials, ensuring compliance with GCP, FDA, and global regulatory requirements.▪ Collaborated with cross-functional teams, CROs, and investigative sites to manage study timelines, budgets, and deliverables.▪ Identified and mitigated risks throughout the trial lifecycle, ensuring high-quality data collection and adherence to protocol. ▪ Assist in the coordination of clinical trials by supporting site management, regulatory documentation, and trial logistics.▪ Maintain accurate trial records, ensuring compliance with regulatory guidelines and internal SOPs.▪ Liaise with investigators, sponsors, and clinical teams to facilitate smooth trial operations and resolve site-level challenges.

  • Clinical Trial Manager

    Jul 2005 - Jul 2007

  • Clinical Trial Support Specialist

    Apr 2004 - Jul 2005
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  Sanofi-aventis

  Jul 2007 - Dec 2011

  ▪ Led the planning, execution, and oversight of clinical trials, ensuring alignment with regulatory requirements and company objectives.▪ Coordinated cross-functional teams, including investigators, regulatory affairs, and data management, to drive project timelines and deliverables.▪ Monitored trial progress, budget adherence, and risk management strategies, ensuring high-quality clinical data collection and reporting. ▪ Oversaw the operational management of global clinical trials, ensuring compliance with international regulatory guidelines (FDA, EMA, ICH-GCP).▪ Managed relationships with CROs, vendors, and study sites across multiple regions, resolving challenges to maintain study efficiency.▪ Developed and implemented trial protocols, budgets, and risk mitigation strategies while ensuring timely data collection and reporting for regulatory submissions.

  • Clinical Project Leader

    Sept 2009 - Dec 2011

  • International Clinical Trial Manager

    Jul 2007 - Sept 2009
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  ICON plc

  Mar 2012 - Jun 2015

  Senior Clinical Trial Manager

  ▪ Operated as primary Functional Lead for clinical operations while heading all facets of site selection, site start-up, patient recruitment, site monitoring, data retrieval, and study close-out.▪ Conceptualized and initiated effective risk mitigation strategies, applicable action plans, and issue resolution. ▪ Advanced the performance of Trial Managers and Trial Associate team members, creating a unified program staff through direct line and functional line management.▪ Directed the clinical operations project team and certified full compliance with SOPs, ICH GCP guidelines, quality standards, study contracts, and budgets.▪ Coordinated and conducted thorough quality reviews and trend analysis of sponsor deliverables, including data, metrics, and monitoring reports.▪ Engaged with clients and other stakeholders while representing the company in an Alliance Partnership Model. Show less

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  Covance

  Jul 2015 - Jan 2021

  Project Director

  ▪ Led global oversight of multi-phase clinical trials across Phase I-IV, ensuring on-time, high-quality, and budget-compliant execution while meeting regulatory standards.▪ Served as Enterprise Engagement Lead, overseeing strategic direction, governance, and operational alignment for key pharmaceutical and biotech clients.▪ Co-led FDA and CRO inspections, achieving zero findings, demonstrating exceptional regulatory compliance and risk management expertise.▪ Chaired Governance Committees, driving strategic resolutions, mitigating risks, and ensuring adherence to best practices in trial execution.▪ Maintained 100% compliance with project performance timelines, streamlining processes to enhance operational efficiency and trial success rates.▪ Executed company-wide initiatives focused on employee experience, leadership development, and succession planning, fostering talent growth and retention.▪ Monitored and optimized clinical project metrics, tracking performance, financial elements, and milestone projections to ensure continued business growth.▪ Aligned strategic objectives with financial analysts, ensuring accurate revenue forecasting and milestone-based financial performance tracking, consistently achieving financial targets. Show less

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  KCR

  Jan 2021 - Apr 2022

  Director Project Management

  ▪ Built and scaled the U.S. clinical operations team, increasing headcount by over 200% to support rapid business expansion and strengthen trial execution capabilities.▪ Led global clinical trial execution across Phase II-III, ensuring full compliance with FDA, EMA, and international regulatory standards while optimizing operational efficiency.▪ Managed multi-million-dollar clinical budgets, implementing financial controls that enhanced cost efficiency, budget adherence, and resource optimization.▪ Developed and launched the Trial Strategy & Analytics function, enabling data-driven decision-making, trial performance tracking, and protocol optimization.▪ Strengthened client partnerships, increasing repeat business and expanding service portfolios through exceptional project execution and relationship management.▪ Trained and mentored clinical trial staff, instilling a culture of accountability, leadership, and operational excellence.▪ Designed and executed risk mitigation strategies, addressing milestones at risk, recruitment delays, and operational inefficiencies in collaboration with cross-functional teams.▪ Worked closely with Project Finance Management, proactively identifying and resolving budget variations to maintain financial stability across trial programs. Show less

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  Parexel

  Jun 2022 - now

  Senior Director, RWE Project Leadership

  ▪ Oversee a multi-million-dollar clinical project portfolio, ensuring strategic prioritization, budget optimization, regulatory compliance, and risk mitigation across global programs.▪ Expand and foster long-term client relationships, securing $36M+ in new business awards in 2024 while managing $130M+ in total contract value.▪ Lead and mentor a high-performing global team of nine project leaders and directors, achieving 100% staff retention.▪ Develop and execute clinical operations strategies, streamlining processes and improving cost efficiency by eliminating redundancies and redistributing task ownership.▪ Serve as Account Delivery Lead for key global clients, managing end-to-end clinical development and post-market studies while ensuring operational excellence and regulatory adherence.▪ Drive operational efficiencies, optimizing workflows, resulting in a 10% improvement in profit margins and enhancing trial execution.▪ Lead risk management and regulatory compliance efforts, successfully completed and passed two regulatory audits in 2024 with zero critical findings.▪ Implement succession planning initiatives, ensuring robust leadership pipelines and organizational agility in clinical operations.▪ Monitor industry trends and emerging opportunities, positioning Parexel for continued market leadership and innovation in real-world evidence and clinical trial execution. Show less