Radhika Sivaramakrishna, PhD, PMP, CSSBB, CCRP
Senior Director, Project
Abstract: Clinical research project management is increasingly conducted globally across multiple time zones and cultures. In order to be successful, certain adaptations must be made to routine practices. This article describes key terms and basic concepts of virtual project management, considerations for effective communication and collaboration tools, and ways in which the Project Management Institute knowledge areas can be applied to a virtual framework. Situational examples are provided. While this has been written in the context of clinical trials performed by a biotech or pharmaceutical sponsor engaging a CRO, the same concepts could easily be extended to any geographically dispersed project team.
With clinical research increasingly moving into the global arena, there is a need for virtual project management. It is impossible to have all members of the sponsor’s project team and the contract research organization (CRO) in one location. It is also too expensive and time consuming to fly team members to one location. Virtual project management enables projects to cost-effectively tap into a wide pool of talent at different locations.
Understanding the key terms in project management and virtual project management is important. Many of these terms are also in the Project Management Institute book of knowledge. A project is a temporary endeavor that is undertaken to create a unique product, service, or result. While clinical trials can sometimes be very long, they are temporary. A project should have a start (initiation), a body, and an end (close out).
A project manager is someone who is assigned by the organization to achieve the objectives of a project. Project management is essentially the application of knowledge, skills, tools, and techniques to ensure delivery of all of the goals that are required by a project.
A virtual project is a collaborative effort toward a specific goal that is based on collective yet, remote performance. Many people may work on a virtual project. The goals of a project are the same whether a project is virtual or traditional. The team, however, is geographically dispersed and members contribute from different locations. It is common for team members to not know each other at the start of a project.
Key Concepts in Virtual Project Management
There are two key concepts for success in virtual project management: effective communication and use of effective collaboration tools. About 90% of a project manager’s job is communication. A project manager must communicate effectively with all stakeholders: internal team, management, sponsor, and members. Effective communication is even more important when managing a project virtually. Typical communication methods are email, telephone, instant messaging, video conferencing, and group Web teleconferencing. It is necessary to use the right tool for the particular situation.
Effective collaboration tools enable seamless sharing of tools and data through effective central systems. Team members located anywhere in the world must be able to access the project management tools.
Quick Tips for Effective Virtual Project Management
Table 1 highlights quick tips for effective virtual project management, starting with being aware of cultural differences and differences in communication preferences. Individual team members will have different preferences for communication methods. It is also important to be considerate of time zone differences. A time for a team meeting that is convenient for the project manager in the United States may not be convenient for a team member in Europe (e.g., morning in the United States might be evening in Europe). The project manager must balance the time zones of team members to determine the best time for team meetings. Holidays in other regions are another consideration.
Email can be overused. Sometimes, it is easier to pick up the telephone and call a team member than to write a long email. Telephone calls are especially helpful when there is a problem to solve and when discussion back and forth is required to sort it out.
The project manager must make virtual team meetings especially effective by avoiding monologues, by encouraging interaction, and by knowing when to speak. Without being able to see body language, the project manager will not know if he/she is boring the other participants. It is important to encourage participation and also to know when to interject without disrupting a call.
Fostering collaboration and interaction even during teleconferences is also important. If more than two people need to agree on something, it is better to arrange a teleconference. While this seems obvious, the author has sometimes seen email used for this purpose. This results in many emails flying back and forth without resolving the issue.
Including a face-to-face meeting in the budget for about every six months is very helpful. Most of the work should be done virtually; however, meeting in person occasionally is helpful, when possible.
Using Email Effectively
Since email is especially important in communicating with a virtual project team, it is helpful to point out even very obvious email dos and don’ts. Every email should have a meaningful heading in the subject line. Messages should be personalized.
It is important to account for the tone of the email and to ensure that it will not seem abrupt, vague, or ambiguous to the recipients. At the same time, the email should not be so long that people will not read it or the writer will not know what the recipient’s response means. Emails should be short and to the point. Including additional contact information such as the sender’s phone number in the email signature is important, as is checking all emails for spelling and grammar.
Be watchful about using “reply to all” indiscriminately or forwarding email without permission. People often click “reply to all” without thinking about this. It is also very easy to forward emails to others. Confidential information should not be shared. Emails should be sent only to the people who need to receive the information. Also, do not think that people other than the intended recipient will not see a message.
Suggestions for Team Meetings
There are many different ways to run virtual team meetings. Suggestions include starting off with a face-to-face kick off meeting. Many large clinical research studies begin with a face-to-face kick off meeting. This gives team members the opportunity to work out the scope of the project and the processes that will be used for project management. It also ensures that the sponsor, CRO, and any other stakeholders have the same understanding of the project from its start.
The next set of meetings can be distributed and managed by telephone or Web conference. The frequency of the team meetings depends on the type of study or project. The project might require a meeting of the entire team once a week up to a particular milestone, such as first subject enrolled. After that, the meetings could be reduced to once every two weeks. Occasional face-to-face meetings can re-energize the project and facilitate team building. After a face-to-face meeting, distributed meetings can be resumed.
Information Technology Considerations
Information technology considerations include maintaining a central repository for shared documents (Table 2). This can be done through a shared folder with standardized documents that all team members can access. Easy access is especially important for global studies. The system should enable multiple people to access the same document simultaneously and have standards for naming and saving documents. There are many systems available. It is necessary to choose a system that is also available in other countries where team members work.
A central budgeting tool is needed to review project financials. The central budgeting tool typically could include financial information such as an earned value analysis as well as standard algorithms for developing budgets while taking regional cost differences into consideration.
Many CROs use a central resourcing tool. Such a tool, which is typically accessible to all project team members, captures the resource availability in different regions.
A central project server that staff from the sponsor and the CRO can access is helpful, enabling the sponsor to see how the entire portfolio of projects is progressing. These days, nearly all facilities use a clinical trial management system that everyone on a distributed project team can access. Electronic trial master files are also becoming very common.
Project Management Knowledge Areas
The Project Management Institute has classified phases of a project into project management knowledge areas. The project management knowledge areas are linked. For each area, the role of each member of the project team and the services needed are identified. In a virtual project, some of the project management knowledge areas must change or become broader. Table 3 highlights the project management knowledge areas and ways that they may be different in a virtual project.
Project integration management encompasses all of the different knowledge areas and integrates all of the services that will become part of managing a project. Tools used in this area include a project management server and Sharepoint®. Central governance is used to review projects to ensure that all projects, irrespective of where the project and team members are located, have appropriate oversight. This is especially relevant in a virtual setting.
Under project time management, project information and documents are stored on a project management server accessible to all team members. Team members should be able to access the same versions of each file. A Central Gantt chart review is used for project time management.
Project cost management includes having a central costing team and central review of the project’s spending and the remaining budget. There may be a central team of financial analysts who are working on these projects irrespective of where the projects are based.
Global quality metrics can be used in project quality management.
In project human resource management, a central resourcing system is commonly used. Using resources intelligently across the globe to cover each study is key to project success.
Project communication management should be the major focus of a virtual project. It is crucial to ensure that communication is not impaired when working virtually. This requires a robust communication plan.
A shared risk register (or equivalent tool for capturing global project risks) that is accessible to the entire team is a key tool in project risk management. All of the risks of the project should be captured in the shared risk register, and the team should collaborate on risk management.
For project procurement management, for large projects using multiple vendors, it is best to use a central vendor manager, i.e., one person who is in charge of procurement for all projects. It would be very messy to have team members in each region handle project procurement. In some cases, this might make sense; however, in general, it is easier to handle all procurement management in a centralized way.
The Project Management Institute added stakeholder management as a project management knowledge area in 2013. In a virtual project, stakeholder management is key. Different stakeholders may have different needs for interaction and communication. The cultures in different regions are likely to be different. Sensitivity is required when considering stakeholder management.
The following two situational examples illustrate virtual project management.
In the first example, a large global oncology study has a sponsor from the United States that is based on the west coast. While it would be preferable to have a project manager in the same time zone or country as where the sponsor resides, in this case, there was no appropriate person and hence an Australian project manager was assigned to manage the study. Regional project managers were assigned to the European Union and to the United States.
No calls about the project could be made on Fridays or Mondays because Friday in the European Union and the United States is Saturday in Australia, and Sunday in the European Union and in the United States is Monday in Australia. It took team members a while to realize this.
Other than that, having an Australian project manager worked out very well. She was already working when other members of the project team were off for the weekend. When staff on the west coast came into the office on Monday, many tasks had been completed. Calls were held late in the evening on the west coast, which was early in the morning in Australia. The sponsor was able to accommodate these adjustments. Once everyone understood the time zone differences, the project worked out very nicely.
The team had a weekly global team conference call, with the frequency adjusted as necessary while moving through the study. Short ad hoc calls supplemented the weekly call. Twice a year, the team met in person. This model really worked well.
The second example is a Type 1 diabetes study with 750 subjects in 15 European countries. The sponsor was in the United States and the study used 20 vendors, including vendors for glucose meters for the continuous glucose monitoring that was required, vendors for quality of life questionnaires, vendors for data management, vendors for investigator meetings, vendors for translations, etc. The team was resourced with a 0.5 FTE (full-time equivalent) for the project director (the leader), who was based in the EU. A 1.0 FTE project manager was based in the United States whose main role was client communication. The project manager in the United States was available if the United States sponsor needed something quickly. Since the study had so many vendors, a 0.75 FTE was allocated for a vendor manager to handle quality management.
Team calls were held at reasonable times for the project managers and the sponsor, respecting the different time zones. Clear roles and responsibilities were established for all team members. The budget included funding for a kick-off meeting at the beginning of the study and for meetings scheduled every six months after that. Sharepoint was used to share documents. Other tools used to facilitate the virtual project were a clinical trial management system and an electronic trial master file.
These accommodations facilitated the necessary interaction without making the project too difficult for team members. For example, the project director outside the United States did not have to work on weekends to be part of the virtual team. Every team member had to be somewhat flexible in order for everyone to work together effectively and as a team.
A project dashboard, housed on a project server, was used to review all projects. All members of the project management team were in one group; however, other stakeholders, such as data management, the sponsor, and the protocol chair (the person who was in charge of the scientific integrity of the protocol) were in separate offices. All stakeholders needed to see the progress of the projects.
The project dashboard containing information on each study was established and placed on the project management server. The project dashboard was color coded to easily show the status of each study across all of the studies. For example, a different color was used for feasibility, enrollment, follow-up, close-out, etc.
Senior managers were able to use the project dashboard to look across the portfolio at any point in time and see, for example, the number of studies that were in the enrollment phase. By clicking on any study, they could also get detailed information about the individual study.
The project dashboard was also used for resourcing projects appropriately. For example, to ensure that project managers were not over-allocated, one would not put the same project manager on two studies that are enrolling at the same time. A project manager might be assigned to one study that is enrolling and to another study that is in the close-out phase.
Virtual Project Management Best Practices
Best practices for virtual project management include managing the goals of the project (Table 4). It is crucial for all team members to be aligned on goals, especially when the team is working virtually. It is more difficult to keep a virtual team together than a regular team.
Rewarding and acknowledging team members and the team as a whole when things are going well is important. Since members of a virtual team rarely or never see the project manager, it is especially important for the project manager to acknowledge them in positive ways. This helps facilitate the commitment of team members to the project even when they are working across the globe. Many companies have the technical ability for a project manager to nominate their virtual team members for awards through a centrally-administered system. Sometimes a simply worded “Thank You,” for an important milestone achieved, could be sent by email, or a shout out to the relevant team member during a teleconference can work wonders!
Another best practice in virtual project management is ensuring effective and interactive team meetings. The project manager must ensure that each team member is getting the most out of the team meetings. Everybody should have the opportunity to contribute. Facilitating active participation over the telephone requires something of a culture shift.
Regular assessment of the effectiveness of remote communication is another best practice in virtual project management. The project manager must always solicit feedback from team members about what is and is not working. For things that are not working, the project manager should solicit feedback about possible improvements. The project manager must take any necessary steps to ensure that communications are effective. For example, if one team member is blocking the participation of other team members, the project manager must take action to give other team members more opportunity to participate.
The last best practice in virtual project management is using collaboration system tools. Team members must receive enough training in the use of these tools to be comfortable when using them. The project manager must also encourage team members to use the tools.
Table 5 lists references from the Project Management Institute related to project management and virtual project management. A great deal of other information is available on the Project Management Institute’s website, and a Google search for “virtual project management” will produce additional resources and references.
Quick Tips on Virtual Project Management
- Be aware of cultural preferences and differences in communication styles.
- Be considerate of time zone differences.
- Be considerate of holidays in various regions.
- When appropriate, make telephone calls instead of sending email.
- Make team meetings especially effective.
- Arrange a teleconference if more than two people need to agree on something.
- Build in a face-to-face meeting every six months, and assure appropriate budgeting.
Information Technology Considerations
- A central repository for shared documents (Sharepoint or equivalent)
- A global resourcing system
- A central budgeting tool to view project financials
- A project management server
- A clinical trial management system
- An electronic trial master file system
Project Management Knowledge Areas for a Virtual Project
- Project integration management:
- Project management server
- Central governance to review all projects
- Project scope management
- Project time management:
- Central Gantt chart review
- Project cost management:
- Central costing team
- Central review of project spending, remaining budget, etc.
- Project quality management:
- Establish global quality metrics
- Project human resource management:
- Use of a central resourcing system
- Resource intelligently across the globe to ensure appropriate coverage
- Project communication management:
- Communication plan tailored to virtual project management
- Project risk management:
- Shared risk register accessible by the entire team
- Project procurement management:
- Centralized vendor management system
- Project stakeholder management
Best Practices for Virtual Project Management
- Manage project goals
- Ensure that team meetings are effective and interactive
- Regularly assess the effectiveness of remote communications
- Use collaboration system tools
References from the Project Management Institute
- A strategic approach to Enterprise 2.0:
- Focus on technology for collaboration
- The virtual project manager: Seven best practices for effective communication
- How’s your distributed team doing? Ten suggestions from the field
- Results from a survey of 150 project management professionals