Clinical Researcher—February 2018 (Volume 32, Issue 2)
Gary W. Cramer
In an era that increasingly seems like it must have been a previous life the longer I focus on clinical research, I once spent three years or so working in a tiny and obscure office known as Development Communications and Special Projects for a large, public university. Basically, that grand designation meant that the handful of employees behind the office’s main door concentrated on writing and editing tasks in support of the university’s fundraising goals—gift proposals, annual reports on philanthropy, press releases on major donations, and the like.
Sometimes I imagined that if I were to stay in that office long enough, I would eventually own the second half of its name, getting a door of my own with frosted glass stenciled with the words “Special Projects.” My plan was to let all who passed by figure out on their own what that meant. If asked what I actually did, I would simply explain, “You know. Special projects. Big picture stuff.” And then I’d walk away as fast as I could.
This Issue’s Big Picture
I took a stroll down that particular memory lane as this issue came together because, to be honest, I had never before really figured out what Project Management meant when I saw it in someone’s job title. I believe I have a better handle on it now, but if you’re in the same boat, I will let you come to an understanding yourself through the insights offered by several contributors in the articles ahead. This big picture view of the topic includes:
- Clinical Project Managers Stuck Betwixt and Between—In this peer-reviewed article, EightSpokes CEO Andy Mehrotra examines why today’s project leads need to evolve their role as part of strategic contract research organizations (CROs). To keep pace with new expectations, sponsors demand that their CRO project managers (PMs) have next-level competencies. In the past, PMs followed defined processes to complete clinical activities on time and within the scope of the sponsor’s objectives. Now, Mehrotra writes, PMs must add new responsibilities for risk management, governance, innovation, and return on investment.
- Project Managers: From Seeking Economic Efficiency to Herding Cats—Special feature contributor Matthew Harrington focuses here on some of the experts who will present sessions at the new Project Management Track at ACRP 2018. The track will bring together veteran practitioners, people new to the field, and those interested in transitioning into project management to share experiences, strategies, and “cat-herding” techniques.
- Partners Address Project Management Challenges for Neglected Tropical Disease Study—As an illustration of a complex project management challenge, this installment of our occasional “Good Management Practice” column presents a Q&A with Mark Sullivan from Medicines Development for Global Health (MDGH) and Craig Rayner from Certara Strategic Consulting® regarding MDGH’s recent submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration for moxidectin as an oral treatment for river blindness (onchocerciasis). A drug development team from Certara has been an integral part of MDGH’s development program and NDA for moxidectin.
You Are (or Can Be) Special…
You will find elements of more project management–related topics sprinkled throughout other articles and columns in this issue. If you have insights of your own to share on this, or any other theme tied to the ever-evolving arena of clinical research, please feel free to contact me about the possibilities for being published in this journal, for contributing your expertise to the ACRP Blog by writing or being interviewed, or for presenting on the theme through a webinar or other ACRP event. Just make the subject line out to “Special Projects”—I’ll know what you mean.
Gary W. Cramer (firstname.lastname@example.org) is Managing Editor for ACRP.