Just like any project, a clinical trial requires stringent management and control of everything from budgets to timelines and collaborators. Clinical trial project management involves thorough oversight of the clinical study, beginning before the planning phase commences, and continuing through the data analysis and submission period.
This article will address:
- What is Clinical Trial Project Management?
- The Importance of Project Management for a Clinical Trial
- What are the Roles of a Clinical Trial Project Manager?
- Clinical Research Project Management with Gsap
What is Clinical Trial Project Management?
Simply put, clinical trial project management describes the steps and processes that an organization puts in place to ensure that a trial is carried out at the highest standard. Clinical trial project management is typically carried out by a clinical research organization (CRO).
A big component of clinical research project management is ensuring the overall quality of a study; that the resulting data is reliable and robust, and that risk management and patient safety are prioritized throughout the trial. Another aspect of clinical research project management is the time management of the study, ensuring that the trial is completed according to the relevant timelines and deadlines.
The Importance of Project Management for a Clinical Trial
Without proper project management, the quality of the data generated from a clinical trial and the progression of the trial itself may not be up to the necessary standard to reach regulatory approval. With so many critical components, like managing partnerships with third-party vendors and suppliers, adhering to timelines, training all necessary staff, controlling all relevant documents, and much more, clinical trial management is essential to the completion of a successful and high-quality clinical trial.
What are the Roles of a Clinical Trial Project Manager?
A clinical trial project manager is a multi-faceted role with many different responsibilities. Some of the primary roles of a trial manager include:
Overall overview and responsibility of study conduct
While various individuals are responsible for specific aspects of a trial, like clinical data collection, quality assurance, site activation, and so on, the clinical trial project manager plays a broader role in the oversight of each of these elements. A crucial component of clinical trial management is coordinating with all specialists and individuals involved in the study to ensure a successful clinical trial.
Study planning and set up
A clinical trial begins long before the first patient sample is collected. Significant study planning and coordination must first be carried out, and extensive document preparation (including study protocols, SOPs, ICFs, and more) is undertaken prior to the commencement of the trial. Study planning plays a large role in clinical trial project management, and it is critical to work with a clinical trial manager who is able to understand the needs and objectives of the trial, in order to ensure timely progression and compliance of the study. Comprehensive planning for the study start will pay off during the study conduct and save time and budget.
Vendors selection
In a majority of cases, a clinical trial can not be executed by a single study team. Third-party vendors are often included in clinical trials to offer expertise regarding specific technologies or specialized clinical procedures associated with patient sample collection. Typically, there are multiple qualified vendors to choose from. Selecting and vetting the most appropriate vendor(s) is another role that falls under clinical research project management.
Milestones follow up
During the planning phase of a clinical trial, milestones should be established to outline various steps and stages throughout the trial. Milestones may include protocol finalization, regulatory and ethics submission deadlines, study site activation, first subject in/out, last subject in/out, completion of data review and statistical analysis, and site closeouts. The clinical trial project manager is responsible for following up on each milestone as the trial progresses, to ensure that all deadlines are met and the study progresses according to the initial study plan.
Communication and escalation
Effective communication is an essential skill that is required by all clinical trial project managers. Communication with stakeholders, within study teams, between sites, with third-party vendors, qualified personnel, and also to regulators and auditors is critical to the progression and success of the clinical trial. The project manager must also understand when to escalate any issues to the appropriate personnel. The clinical project manager is responsible for internal and external communication as well as action items follow-up, milestones etc. The Communication processes enable the Sponsor and stakeholder to be on the same page and progress the project vectors to the needed direction at each time point.
Collaboration with all parties and vendors
As well as initially selecting vendors, the project manager must maintain a collaborative relationship with vendors throughout the study. Successful clinical project management involves close communication and cooperation with all vendors and third-party players. When it comes time to submit final regulatory documentation, the project manager must coordinate with all stakeholders and vendors to ensure the appropriate materials and documents are obtained and submitted.
Timeline and budget oversight
Clinical trials are inherently expensive, and poor project management can lead to study delays, which further increase the costs associated with the trial. Clinical research project management is primarily focused on adhering to timelines and budgets, with the overarching goal being to ensure that the trial is completed according to schedule, and within the outlined budgets.
Study team management, interphases, guidance, and training
Coordinating, guiding, and managing the study team (including clinical research associates, statisticians, QA personnel, medical advisors, and site staff) is another key role of the project manager. Ensuring that appropriate personnel is fully trained according to study protocols and SOPs (and that training is comprehensively documented) is essential in clinical project management.
Project Management Plans
The project manager is responsible to ensure that each component of the study has a plan in place which is comprehensive, study-specific, current throughout the study, and updated as needed in order to cover all study aspects. The plans include a Clinical management plan (CMP) that outlines the scope and study-specific procedures, a Quality plan that ensures QC and QA procedures will be performed throughout the trial, a Data management plan (DMP) which outlines the plan for the collection and management of clinical data throughout the duration of the trial and more as needed.
Risk management
Assessing and managing risks is a significant element of clinical trial management. Risks might include IRB approval delays, issues with patient recruitment, unexpected staff turnover, unplanned protocol changes, etc. The role of the clinical project manager is to assess the probability of a given risk occurring, the impact that it would potentially have on the trial, and, of course, how to mitigate each outlined risk.
Clinical Research Project Management with Gsap
Gsap is a boutique CRO with vast experience managing a diverse range of clinical trials, including in the pharma, Medical Device, Digital Health, Diagnostics, cannabis, and gene/cell therapy fields. Gsap’s vastly experienced team can manage your project in close collaboration and partnership with all relevant parties and vendors, with respect to timelines, milestones, training materials, sites support, in-house monitoring, open action follow-up, eTMF, CMP, and internal SOPs. This approach ensures a high level of project management and quality of study conduct, leading to the success of your trial. To learn more about Gsap’s clinical trial project management services, contact Gsap here.
This article was prepared by:
Matti Hoggeg, M.Sc.
Clinical Section Manager
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