/publications/career/2007/Careers_2007-01/Careers_2007-01_4324

A JUGGLING ACT: MULTI-TASKING IN CLINICAL TRIALS OPERATIONS

Author: Carolyn Heinze

ON ANY GIVEN DAY, KATHY Yurkow may change hats more than some of the world's most celebrated fashionistas?and she likes it that way.

As the associate director of clinical operations at Johnson & Johnson Consumer and Personal Products on the company's campus in Skillman, NJ, Yurkow, who received her pharmacy degree from Rutgers University, is required to constantly change her focus in order to keep her section moving forward.

"The most challenging aspect of my job is the same reason that I like it?you are spread across multiple functions," Yurkow says. "You will be talking about the clinical aspect of vision and eye drops, and then have someone from the wound care section talking about how their clinical supplies are not labeled. You need to make the transition from thinking about how one team is scoring something to how come a batch record was not done right. They are not connected at all."

Back when she was considering her career options, Yurkow's first choice was to be a teacher. When it became apparent that there were not a lot of jobs open, she shifted her focus to pharmacy?a profession that, in the end, is all about helping people. Prior to accepting this position, she worked as a data management specialist for Pharmaceutical Research and Development at Johnson & Johnson. "That job involved overseeing all of the data management aspects of the drugs that we were working on," she recounts. "That started with the development of the case record forms and the imaging system, to data management, data entry, and edit check specifications?I oversaw that piece of it and brought it to the table for when we were making decisions." Before that, Yurkow worked in Titusville, NJ, also in data management, including data transfers and coding. This post called for experience in data management, clinical trials, and clinical supplies, and the move into the clinical side of things stemmed from a desire to witness trials up close and personal.

"I thought that being up closer at the front of the trial and being able to decide how the trial was going to be run was where I wanted to be," Yurkow explains. "Also, it is a smaller company; I get to see a lot more right now than I did when I was in the bigger pharma company. You got to see data management, but you did not get to see a lot of the different areas. Here, the people who actually do the formulations are in the labs next door.You get to see the wider breadth of what the whole drug development process is."

Yurkow begins each day with answering phone messages and correspondence from her counterparts in Europe. As of press time, Yurkow's section was working on trials in France and Denmark, for which they are responsible for clinical supplies. This takes her to about 11:00 AM, when the workday in Europe comes to a close. Following that, she addresses any obstacles that her team?which consists of a trial manager for the dermatology group, a trial manager for the wound care group, and an individual responsible for coordinating clinical supplies, packaging and labeling for toiletries, and vendor management?is facing, so that they can get on with their day. "I try to handle whatever issues they are dealing with in the morning, because if I do not handle them, then they get stuck for the rest of the day on that one piece," she explains.

Yurkow's campus generally conducts topical studies and some studies involving devices. Currently, her section is running a trial on a topical product on cold sores both in the United States and Europe; Yurkow was expecting an interim analysis by mid- November. The team also was performing a trial study for the administration of an Rx drug; the trial was in phase 4 as of press time. "It's a preference type study," Yurkow explains. "It's an Rx drug, but we are testing the preference between using a pump versus a tube, versus [another device]." She added that they also are running a phase 3B eye drop study.

Yurkow reports to the director of clinical operations, medical writing, and worldwide finance. "She is right now submitting an NDA [new drug application] for a new product, so if there is anything she needs to support the submission, I research that information and provide it to her," she explains. "She also looks at all of the timelines for all of the projects, to make sure we are meeting interim analysis, and so on."

After these matters are taken care of, Yurkow consults the messages and e-mails that fly back and forth between those involved in the current trials that are taking place. Then it is time to attend meetings, or, in the event there is not one, to review minutes from previous gatherings. The ultimate goal: to plan well enough in advance so that everything runs as smoothly as possible.

This is not always easy, considering that one must factor in a margin for human error, Yurkow concedes, referring to a problem her team encountered before her interview with Pharmacy Times. "We had trained one of the sites on this one scale, and when the monitor got down there, she looked at the results in the casebook, and it was obvious to her that they hadn't been following the directions," she relays. "We had to make a decision on what was to be done with that data." At this point, the question became: Was there any way that we could salvage the data and use it in the study? "With this one, we were lucky?there were pictures. They were able to use the pictures to recalculate their answer."

While looming deadlines are Yurkow's least favorite part of the job, it is worth it when she witnesses the progress that the pharmaceutical industry is making. "My favorite part is being involved in the set-up of the clinical trials, because you get to see the new drugs that are out there," she says. "These are not curing anybody yet, but they are still cutting edge for what they are doing, and that is the best part of it?being able to get that trial started and see how that drug is working."

Yurkow observes that her field has undergone a significant change over the last several years, demanding more experienced professionals to fill positions like hers. "There are not a lot of entry-level positions in this area because we don't have the time to train people," she notes. "What you actually see are people who have several years of experience that are being brought in rather than people who don't have experience. You are overseeing vendors, and if you don't know what they are supposed to be doing, then you really can't manage them." She attributes the lack of entry-level jobs, in part, to the use of cheaper labor in other countries, such as China and India.

That is not to deter those seeking to pursue a similar career path, however. Yurkow believes that those who earn pharmacy degrees are well positioned to go after a vast range of jobs. "With a pharmacy background, you can go between a lot of different jobs within the pharmaceutical industry," she advises. "It pays to go and get a degree where you can do more than one job, rather than focusing on a pure science that limits you."

Ms. Heinze is a freelance writer based in Vancouver, British Columbia.