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Project Management

Experienced Project Managers serve as your dedicated guide and single point of contact from study award through archive. Strategic oversight, proactive leadership and seamless coordination keep your study on course and aligned with its objectives.

Discuss your project management needs

What we deliver

  • A dedicated Project Manager who serves as the central point of coordination between the sponsor and the study team, providing complete visibility into study progress
  • Project plans that combine scientific understanding, operational expertise and proactive communication to ensure studies are completed within budget and in full compliance with regulatory and sponsor requirements 
  • Detailed project timelines to keep milestones on track and schedules aligned
  • Management and coordination of all contracted vendors to ensure project requirements, timelines and quality standards are clearly communicated and consistently achieved
  • Risk mitigation strategies and contingency planning developed and managed throughout the study
  • Project-specific training by identifying training needs, coordinating training schedules, maintaining documentation and ensuring study team readiness and compliance with applicable procedures.
  • Post-study Lessons Learned sessions to evaluate project performance, identify successes and challenges and develop actionable recommendations to support continuous process improvement

Experience snapshot

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Point of contact throughout your study
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Average years of PM experience

Our project management approach

Every successful clinical study begins with a detailed project plan. Before study initiation, we define clear objectives, responsibilities, communication pathways, milestones and risk mitigation strategies. Project managers coordinate daily study activities among sponsors, investigators, vendors, laboratories and internal teams to ensure seamless execution. Throughout execution, our team proactively identifies potential challenges and implements solutions to minimize delays while maintaining quality and compliance. This structured approach supports successful study completion, delivering high-quality data, regulatory compliance and sponsor satisfaction.

01

Pre-study

  • Develop project plans and detailed timelines
  • Manage project-specific training requirements
  • Implement risk identification, assessment and mitigation strategies to support timely study start-up
02

During the study

  • Lead team meetings and serve as the primary liaison between the sponsor and study team
  • Manage vendors and maintain project plans and timelines
  • Track clinical conduct and key project milestones to ensure timely and successful delivery
03

Post-study

  • Organize post-study Lessons Learned meetings
  • Document insights to support continuous process improvement

Our project management leadership

Project management is an integral part of Clinical Trial Services, supported by dedicated teams and experienced leaders who remain engaged throughout the study lifecycle. This continuity preserves institutional knowledge, strengthens collaboration and ensures consistent execution from start-up through closeout.

Beth Williams

Vice President, Clinical Trial Services

18 years of experience

Sara Roman

Associate Director, Project Management

16 years of experience

Jeff Heinzman

Associate Director, Project Management

12 years of experience

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Technology, tools and systems

Project management is supported by a comprehensive ecosystem of technologies, tools, and systems that enhance organization, visibility, communication and operational oversight throughout the project lifecycle.

Centralized project planning software enables Project Managers to maintain timelines, track milestones and deliverables, manage risks and coordinate cross-functional activities. It also provides visibility into key study information, including contact lists, project-specific training matrix, action and decision logs and other operational trackers.

Project Managers also utilize a Clinical Trial Management System (CTMS) to support study oversight and operational management. The CTMS provides centralized visibility into study milestones, site activities, enrollment, monitoring and other key operational data.

In addition, the electronic Trial Master File (eTMF) system provides centralized management of essential clinical trial documentation throughout the study lifecycle. It offers visibility into document collection, filing activities, TMF completeness and inspection readiness, while supporting collaboration with study teams to maintain an accurate and complete TMF.

Sponsors are provided with appropriate access to these technology platforms, enabling real-time visibility into the overall study status throughout the project lifecycle. 

Quality, standards and compliance

Quality is embedded throughout the project lifecycle, from study planning and start-up through execution, monitoring and close-out. Our project management processes are guided by ICH Good Clinical Practice (ICH-GCP) ensuring that scientific integrity, volunteer safety, data reliability and regulatory compliance remain at the forefront. 

Connected across the full study lifecycle

Project management connects the work of all DVCR functions, ensuring the program progresses as a coordinated effort. Your Project Manager aligns activities across data management, biostatistics, PK/PD analysis and/or modeling, clinical monitoring and medical monitoring, ensuring seamless handoffs throughout the study lifecycle.

Related resources

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Talk to a project management team focused on early phase execution.

From first milestone to final deliverable, a dedicated Project Manager provides consistent leadership, proactive communication and seamless coordination to keep your study moving forward.

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