Late in the week at 2006 DIA, there was a provocative session about clinical data management, which is not exactly something Stephen King could use to create his next thriller. No matter: the speakers brought the material to life anyway.
Joseph Anderson, principal associate at Waife & Associates is a case in point. Currently based out of North Carolina, Anderson lived in Germany for a good spell and has been advising clients on clinical technology for 15 years, which is longer than some companies in the space have been in existence.
Anderson offered an unhedged prediction: Data management is doomed as an occupation. It is a dinosaur waiting for the meteor to strike. “EDC [electronic data capture] will obviate the need for data management as we know it,” Anderson said. “The world has gotten incredibly small and it’s changing our thinking about how we ought to do the piece of work called data management.”
Anderson (like his boss, Ronald S. Waife) is not one to mince words. “Some pharma companies in data management are massively overstaffed. They have two times, three times, and four times as many people as other companies that are doing the same kind of work. We really haven’t paid attention to cost. There are alternatives.”
The audience was chuckling, in part because of Anderson’s Lettermanesque timing and delivery. But it could deadly serious stuff if your paycheck depends on a data management department. And that, Anderson believes, is at the heart of why the jobs are there—an entire career could be lived in data management. But that’s already dissolving.
Anderson believes that some companies, aware of the reduction in queries thanks to EDC, are rethinking data management head counts: “Everybody is rethinking this on a massive scale,” he said.
The new concept, he thinks, is not just moving the jobs to India and other places, although the jobs are indeed moving overseas. Anderson dislikes the term “offshoring.” He’d prefer the notion of “remote data management” because he believes the work will be done on a much more efficient scale and not on the basis of a single trial here or there.
As Anderson explained: “Remote data management is localizing and centralizing data management services not on a trial-by-trial basis, but on an enterprise basis to optimize cost and quality. That’s what’s really going on. It is time to re-establish the value proposition for data management. This is unavoidable for everyone.”
Anderson is prepared to watch people walk out of his presentation, he said. Remote data management puts a premium on clear electronic communication. If you have a colleague down the hall, you can walk over to explain your instructions, your problems, your sense of humor, your idea. That’s harder if your colleague is in Shanghai. On email, there is no body language. “I’m much more concerned about execution,” says Anderson. “Your execution has to be better than ever before, or you won’t be able to take advantage of the opportunity.”
In the same session, the attendees had the pleasure of listening to Lauri Sirabella, executive director and site head, clinical study and data management, at Pfizer. Having also worked at Bayer, she’s been doing this stuff twice as long as Anderson. If you’re counting, that means she started late in the 1970s.
Sirabella’s crystal ball has a vision that is similar to Anderson’s. She believes that the traditional clinical data management job is being reinvented across the industry. So-called “soft” skills, people management skills, which cannot be squished into a shrink-wrapped box, will come into their own. It’s not about locking a database. It’s about building relationships and teams.
Sirabella cheerfully related a bit about some recent reorganizations at Pfizer, some of which have been triggered by massive acquisitions like the Pharmacia purchase. Some have been more strategic. It’s not clear the process has finished. But the company’s commitment to electronic data capture (EDC), she says, is complete. “We still do a few paper studies, but we are primarily an EDC organization,” Sirabella said.
At Pfizer, she reported, her data managers are learning to manage the FSPs. What, you may ask, is an FSP? A functional service provider. Perhaps it’s a clinical site manager. A central lab. A statistical firm. Classical data management. Each such entity typically works under a master contract with pre-negotiated pricing.“ These partners are all off-site,” said Sirabella. “You can move them from project to project. This is a new model. People have to get used to working in a virtual world.”
Pfizer, she said, believes that its own staff will need strong project management skills. She didn’t say this, exactly, but our impression was that some of the old data managers are adapting well—and others may not be. It can be hard to resist the temptation to “hover,” as it were, over the shoulder of the person doing the work you used to perform a dozen time zones away.
Sirabella added: “The key is training. The skill we are working on most is how to be a project manager and oversee others. These people know data management very well. They’re used to doing that themselves. They now have to move away from that and oversee someone else, who is not there, who is halfway across the world. How do you let go of doing the work yourself? How much do you delegate? It’s a lot of soft skills. It’s not a lot of technical skills.”