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Q&A

When did you realize you wanted to work in clinical research documentation?

There was never a real intention on my part to go into the field of management of clinical research documentation. I spent the first half of my professional career in the management of clinical trials. I just happened to land in this specialty, which is one on the great spectrum of careers in Pharmaceutical R&D, because I like order. I was drawn to the field because I had the desire to put consistent processes in place that people could easily follow around the management of the documentation—the type of documentation that proves that company procedures as well as regulations regarding patient safety and data integrity, were followed. I wanted to ensure that the documentation was in the right place at the right time and available for reference as well as for audit and/or inspection. Just goes to show you that, in the field of R&D, there are so many opportunities for your skillset and passion.

What do you like most and least about your job?

In my current position I am an independent consultant. I’ve held positions at the investigative site, Contract Research Organizations, a mid-size biotech company, and one of the largest pharmaceutical companies in the world. My current position allows me to help each of these different types of companies to improve on their process for the management of clinical research documentation they create in support of their clinical studies. I meet such fantastic people who are searching to establish quality and consistency in their processes. Most of my projects are short, less than a year, so I do not get into slumps or ruts. There is nothing, absolutely nothing, I do not like about my job.

What is the first book you remember reading?

The first book I remember reading is a classic called Little Bear by Else Holmelund Minarik and Maurice Sendak. It was written in 1957. It is about a little bear who has the luxury of a support system, in the book it is Mother Bear who helps him prepare for adventures and, upon his return from these adventures, provides the warmth, safety, and the goodness of home. In retrospect, it captures how my own life has proceeded. I, like Little Bear, have been afforded the support of my parents, spouse, children, family, friends, and my professional managers, colleagues, and mentors to take personal and professional adventures and risks, which in turn has allowed to me continually grow in my skills and ability to have a positive impact on our industry.

What advice would you give your younger self about to enter the “real world?”

I would tell myself 3 things: (1) It is easy to get into the rut of doing the same thing day after day; just meandering through and to try not to let this happen since this is not what life is about. Seek to intentionally soak in the little things that happen even on what might appear to be the most mundane of days. Some day when you look back, those little things were actually the big things that make such differences in your life. (2) You are what you are when nobody is looking. Seek to be the best person you can be, not because you have to show it to others, but because you want to for your own sake and need. (3) Educate yourself and then stand up bravely against what you think is wrong. Toleration of injustice, on any level, is destructive to the society in which you live.

How has DIA helped you?

I was just starting out as an independent consultant and I was given the advice to join DIA and a group of committed volunteers in the Document and Records Management (DRM) Community, who were working together on a project. What I quickly learned was that the DIA was a platform for me to find and establish connections with other professionals, like me in my area of specialty, who were driven to improve the industry because we knew it could and should be done—thereby making the overall process for developing new medicines and devices more efficient. I have maintained so many of these early connections even today, 12 years later, as we continue to work on projects that change how our industry works. Through projects managed via the DRM Community, I learned how to harness the great power of a group of volunteers driven to succeed in a common goal. Opportunities like this can be available to all DIA members; if one only wants to take the reins.

BIOGRAPHY

Lisa D. Mulcahy has more than 25 years of experience in the pharmaceutical industry in the areas of Clinical Operations and Quality Management. More than 10 years ago, she became an independent consultant, focusing solely on Trial Master File (TMF) processes and management, assisting clients with assessment and improvement of their current state, development of future design, and implementation of systems for the management of electronic records of the TMF. She is experienced in the quality assessment of study-specific TMFs and an industry thought leader in the management of the TMF. She is also a frequent speaker and experienced workshop leader at TMF-related professional meetings. Mulcahy is chair of the DIA Document and Records Management Community. She led the team of industry representatives who recently reviewed and revised the Framework for the Destruction of Paper, v2.0. She is a co-founder and a Steering Committee member of the volunteer team of industry representatives that created, maintains, and expands the TMF Reference Model.