“The only constant in life is change.”- Heraclitus
Project management increasingly demands the judicious use of emerging technology, deft management and collaboration across multi-cultural teams, and knowledge sharing of challenges confronted across projects, lessons learned, and successful management strategies. These processes coexist within the context of the overall health of the project and individuals who form the team. The secret sauce for success is maintaining strong relationships between stakeholders. Today’s project manager (PM) must maintain balance multi-tasking from high tech to high touch, leading projects of increasing complexity with shortening timelines.Emerging Technologies in Project Management: Artificial Intelligence
Artificial Intelligence (AI) is ascendant at a time when projects are increasingly complex, creating a role for greater efficiency while challenging project managers to oversee correct and safe implementation.
A recent seismic shift in clinical research has followed the sudden public release of artificial intelligence. (e.g., OpenAI platform ChatGPT, Google Co-Pilot, etc.). Management of experimental technologies (e.g., generative artificial intelligence) have rapidly sprung to the forefront as these tech tools have been made widely available to industry and the public. There is the risk of overdependence and misplaced trust in AI. Machine learning for generative AI requires huge amounts of data; some purposefully fed into the machine but with the majority received adventitiously through public use which could endanger intellectual property, reveal confidential information, or create significant security risks.
AI is becoming a key accelerant in data analytics. One recent example was the role AI played in the COVID-19 mRNA vaccine development that produced review-ready data in 22 hours, as opposed to normal methods that take greater than 30 days. AI has been used to boost the recruitment of research study candidates (e.g., Trial Pathfinder, etc.).
While AI has rapidly demanded integration into project management tasks, workflows, risk identification and resource allocation, total trust and reliance on AI is a mistake. AI is not “out of the box” turnkey for use in clinical research projects. There is great potential in AI, but there are also significant risks and limitations. Procedures and oversight must be in place to monitor AI accuracy (output is only as good as open-source data fed into algorithms), quality, and confidentiality, which cannot be taken for granted. There must be rules, policies and procedures known to all to be followed to stay safe with AI, and it is key that AI output be QC’d prior to use or release. Consensus must be documented at the outset of AI use on any project to define mutual understanding of how AI will be managed project-wide, and questions must be considered. For example, in regulated clinical research, is AI “validation” needed or possible? What will be the stance of regulatory authorities when it comes to AI?
Real world examples of the benefit-risk of AI include notetaking during project meetings by any involved stakeholder (project, third-party vendor, etc.). Perhaps the project is contractually bound to provide minutes of meetings documenting actions, agreements and decisions. What are the implications if other “versions” of minutes may be taken by attendee notetaking via AI? Etiquette always matters; AI use is no exception. The PM should continue to ask about AI notetaking first and scan attendees on Teams meetings for attendees by AI notetaking bots which may be identified by names ending in “.ai.” Always check attendees before starting a meeting to make sure all attendees are human and known to the team.
Key Takeaway: AI is useful when used carefully and correctly but it cannot replace human faculties like common sense, intuition, and professional/medical training. Output must be carefully QC’d and not accepted as correct on face value.
How do we evaluate our third-party vendors when it comes to the use of AI? What if they are using AI for internal purposes to take minutes on one of our shared projects? If the vendor does snot have proper security in place they could be exposing sensitive or proprietary information for public consumption. This is true for all project stakeholders. The precautions need to be highly emphasized and mutually understood, especially when no policies or guard rails are in place.
Digital Collaboration
Digital collaboration uses digital tools to support teamwork, communication, and information sharing, regardless of the physical location of team members. Tools may include project management software (e.g. Jira, Trello, etc.), communication platforms (e.g., Microsoft Teams), and online whiteboards (e.g. Miro). New releases of software may permit real-time document editing, video conferencing, online brainstorming sessions and shared project dashboards, etc. The overarching goal of these tools is to foster team collaboration by breaking down communication barriers.
Collaboration quality relies heavily upon the quality of communication integrated into project plans and planning. Microsoft Teams is now an integral tool in project management partially eclipsing Outlook for some tasks.
Knowledge Sharing through Internal Review of Project Case Studies
“Those who do not study history are doomed to repeat it.” - George Santayana
Knowledge sharing in project management occurs continuously. Forensic exploration of the record of issues documentation and timely escalation offers learning opportunities through shared experience. For example, company-wide consideration of project case studies is a value-added method for exchanging shared experiences and strategies. This presentation and discussion, as “Lessons Learned”, may occur at any point in the life span of a project and it may be good to integrate into ongoing evaluation/processes.
Tracking of risks, actions, issues and decisions may benefit from adding tracking of insights, or “aha” moments, gained through “Lessons Learned.” Project Management and overall team perspectives are shared with an emphasis on Principal Investigator (PI) oversight and delegation, informed consent processes, subject eligibility, site staff and team turnover, and a full assessment of source documents/supporting data. Site visit documentation and site communication serve as the demonstration of real-time site management and problem solving. Sharing retrospective “red flags” for awareness of early warnings, crisis management techniques, and intuitive and empirical findings combine to inform the wider organization. Finally, such cross pollination offers key takeaways and opportunities for improvement. Everybody wins.
Global Multicultural Teams
"Alone we can do so little; together we can do so much." — Helen Keller.
Communication is becoming increasingly complex, and a deep understanding is crucial to manage key project issues. Over time, in business environments, email has replaced formal letters, text messaging has replaced email, and so on. Preservation of a written record remains a key project priority.
Clinical research development teams are fueled by a variety of international cultures and languages that are spoken by people of various ages. The Boomer generation, Millennials, and Gen X may reach the correct destination using their own path, while the Project Manager is charged with minimizing friction and promoting successful collaboration. This requires a delicate balance and an eye on relationships for signs of overstrain within the team. Email communication is especially prone to misunderstanding. The Project Manager in these fast-paced electronic and virtual times must monitor emails for tone/friction. Project Managers are often the ones to help team members realize when it is time to pick up the phone or when signs of keyboard warrior behavior are seen.
In addition, awareness of differences in decision making, negative feedback perceptions, confrontation and leadership styles (hierarchical top down vs. egalitarian) are key considerations. Staying open, curious and ever respectful may bring complementary discoveries as all work together.
Looking Forward
“Be kind. For everyone you meet is fighting a battle you know nothing about.” - Ian Maclaren
In closing, it is an exciting time to be a Project Manager. Kindness may seem low-tech and tangential, but it plays a central role in getting the work done and feeling good about being part of a team. At the end of the day, we all have a shared goal of developing promising treatments to better the lives of patients all over the world.
Author:
Karen Gammon
Senior Project Manager, Linical