Clinical Trial Project Management
Collaboration and multitasking for safe and effective research
Clinical trial project management is the process of planning, executing, monitoring and controlling clinical research studies, with the goal of bringing new drugs and medical devices to patients safely and effectively. It requires close collaboration with regulatory authorities, medical experts, investigators, site coordinators and other members of the clinical trial team, as well as the ability to manage multiple stakeholders, data points, timelines and budgets simultaneously.
What is the role of a project manager for clinical trials?
Project delivery brings together functions critical to conducting end-to-end clinical trials, from the operational strategy design to the submission of final data. Key to project delivery are project managers, referred to by role as project leads. Project leads are aligned to their areas of therapeutic expertise and are the primary client contact at the study level.
Project leads
- Create a Project Management Plan that outlines how the study will be managed, to ensure that all deliverables are met within contracted timelines and budget and with high quality
- Are accountable for the overall operational delivery of the cross-functional project (time, cost and quality)
- Manage and deliver to study timelines
- Act as a partner with the sponsor by establishing, communicating and managing expectations to achieve optimal delivery during the project
- Ensure clear delineation of responsibilities and communication and escalation pathways for functional leads on the project
- Manage project budgets and ensure financial stewardship
- Drive risk identification and issue resolution
- Ensure quality of deliverables through oversight of project team compliance with standard operating procedures (SOPs), International Council for Harmonisation (ICH)’s Good Clinical Practice Guidelines, and other regulatory and project-specific requirements
More specifically, project leads are responsible for:
- Creating a project management plan: Outlining how the study will be managed to ensure that all deliverables are met within contracted timelines and budget, and with high quality
- Gathering resources: Ensuring that staff and equipment are available to perform required tasks and/or vetting and coordinating all services and outside vendors (e.g., labs and imaging)
- Maintaining safety standards: Protecting all those involved in the trial
- Monitoring the trial budget: Confirming that the work is within approved parameters while managing out-of-scope costs and contract modifications
- Staying on schedule: Ensuring the timely completion of each phase of the trial
- Communicating with trial partners: Meeting and working with outside parties, such as physicians, vendors and regulatory agencies, and sharing feedback from the trial sites with the sponsor
- Creating reports: The project lead regularly generates and distributes key status and performance indicator reports that track a study’s progress. This transparency plays an essential role in keeping stakeholders informed.
Historically, project managers followed a defined scope of work to complete clinical activities on time and within budget, adhering to the basic service paradigm of time/cost/quality. However, in recent years, the pharmaceutical industry has come to expect project managers to proactively manage and control processes and offer innovative solutions to risk, improving return on investment for the clinical trials they oversee. In summary, the project manager is responsible for the entire study, end-to-end.
Difficulties in patient recruitment may lead to cost overruns due to overall timeline delays or additional work needed. In these situations, a project lead will ensure accountability for the time and money spent, in addition to managing expectations should these elements start to change over the course of the study.
Effective project delivery: a team effort
In addition to project leads, other key roles in clinical trial project management are:
Oversight directors
Oversight directors provide strategic and operational project leadership, client management and accountability within a specified therapeutic area. Their responsibilities include:
- Expertly navigating the need to dive in and out of situations while ensuring the project lead remains empowered
- Communicating with people managers to support the development of employees
- Providing expertise and perspective related to client needs, indication and therapeutic knowledge
Startup managers and clinical trial managers/clinical team managers (CTMs)
The startup team manager oversees from study award to site activation. The CTM ensures consistency and efficiency across all regions, per the project contract, and is accountable for the clinical deliverables at a project level, verifying that timelines, resources and quality are maintained. Specifically, the CTM will:
- Provide project-specific leadership, therapeutic knowledge and direction to the clinical team to achieve project goals (including project-specific training, guidance and motivation when needed)
- Develop functional project plans and tools, such as the monitoring plan, study-specific recruitment and retention plan, and recruitment projections
- Ensure appropriate system setup, such as the Clinical Trial Management System and Trial Master File (TMF), to support the clinical execution
- Lead the development of the monitoring strategy at a project level, accounting for potential risks and offering solutions when issues arise
- Utilize data sources available to proactively identify emerging risks, drive the clinical delivery and form solutions
- Collaborate with the project lead and other stakeholders to prepare, organize and present during internal or external meetings
- Maintain compliance with respect to applicable SOPs, ICH-GCP, regulatory and project-specific requirements
How does clinical research benefit from project management?
With clinical trials becoming increasingly complex, pharmaceutical/biotech industry competition intensifying and public/government entities pushing to improve research standards, project managers can:
- Ensure that best practices and regulatory legislation are followed, supporting the integrity of a trial and its results.
- Facilitate the smooth running of the trial, allowing other members of the project team to focus on their areas of expertise.
- Support clear communication between the trial sponsor and project team, ensuring transparency and facilitating the detection of problems via ongoing monitoring of the trial’s critical path.
In short, having a dedicated project manager to provide centralized management of all trial processes, SOPs and subsequent documentation can help keep clinical research focused and moving forward.
Clinical project special considerations and strategic solutions
Management of clinical trials requires more than just logistical and administrative oversight. Because the pharmaceutical industry is highly regulated, project managers must think strategically and take into consideration every aspect that could impact the trial outcome.
The safety of participants is always the top priority in clinical trials. Project managers must oversee robust safety measures to protect participants from potential harm.
The purpose of ethical guidelines in clinical research is to protect patient volunteers and to preserve the integrity of science. For example, project managers can provide feedback to a sponsor if it appears that a clinical trial’s potential benefits do not outweigh the safety of participants.
Clinical trials must be conducted in accordance with all applicable regulatory requirements. Project managers must be familiar with the regulatory landscape and ensure that all trial processes comply with industry guidelines and legislation.
Clinical trial data must be accurate and reliable to produce meaningful results. Project managers must oversee quality control measures to ensure the integrity of the data.
Project managers must prepare for and respond to real and potential risks that could compromise the trial.
View examples
- Long wait times for Institutional Review Board (IRB) approval or other regulatory hurdles
- Delays in patient recruitment
- Turnover among site staff
- Changes to the trial protocol
- Adverse events in participants
Risk-based monitoring focuses on identifying, assessing and mitigating high-risk areas and activities that could affect the quality, safety or success of the trial.
FAQs
What common clinical trial issues are improved by having project management?
- Aligning cross-functional team deliverables, keeping all functional team members on track with their respective timelines, and working with the team to minimize upstream delays
- Overseeing the rollout of amendments and changes to the protocol to ensure all functional groups are kept informed
- Overseeing team training on study materials
- Addressing personnel turnover
- Maintaining regulatory compliance
- Providing guidance for more effective recruitment and improved blinding
- Promoting more efficient use of technology
- Overseeing system access and controls to maintain security
- Managing the overarching documentation (e.g., Trial Master File) of how the study was conducted (see next question)
What is TMF in project management?
TMF stands for Trial Master File. It is the primary repository for all data from the clinical trial; essentially, the story of how the trial was conducted and managed, which allows it to be reconstructed and evaluated. The TMF should include, but is not limited to, the following folder structure:
- Trial management
- Central trial documents
- Regulatory documents
- IRB materials
- Site management
- Investigational product and trial supplies
- Safety reporting
- Central and local testing
- Data management
- Statistics
