What exactly does a medical monitor do?

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Pharma can be very confusting when you’re exploring nonclinical jobs.

What exactly does a medical monitor do? How about a drug safety officer? Or an MSL?

We never learned about these jobs on Sesame Street. And when people describe what they do, it can leave you scratching your head.

You’re hesitant to ask them questions because you don’t want to sound stupid.

Today you’re in luck because Dr. Kelly Curtis is here to demystify the position of medical monitor. Dr. Curtis is a board-certified oncologist who worked at Mayo until he transitioned into his current position as Senior Medical Director and Medical Monitor for Syneos, a Contract Research Organization (CRO).

CROs run clinical trials for pharmaceutical companies and can be a good entry point for physicians interested in pharma.

If you’re curious about a nonclinical career as a medical monitor, please read on!

What made you decide to leave practice and transition to a nonclinical career?
There were several factors. I primarily enjoyed the research aspects of my academic career, but the demands of clinical medicine increasingly crept into my protected time for research. There was never any true “protected” time to do research, as I was always being asked to squeeze in extra patients during this time or tend to other clinical demands.

Despite my focus on solid tumors, I was being asked to take call for the Hematology service when there was a lack of coverage, which I found particularly distressing as I was not an expert in Hematology. Other dissatisfiers included the inane demands of the EMR, having to straighten out scheduling snafus, managing conflicting opinions among specialists on how best to care for a cancer patient at the end of life, call, and long hours.

I explored non-clinical careers for several years before making the transition, and once a job opportunity presented itself that did not require relocation, I took it.

How did you find your first nonclinical job?
I worked a lot with Heather, discussing my interests and what would be a good fit. She helped me develop my resume to better highlight my research experience, making it attractive to recruiters and industry hiring managers. We worked on a LinkedIn profile. I attended the SEAK Non-clinical Careers for Physicians conference, where the value of creating a LinkedIn profile was reinforced. Ultimately I was contacted by a recruiter through LinkedIn about my first (and current) non-clinical job.

Can you describe what you do as a Senior Medical Director and Medical Monitor?
“Medical Director” is a common job title for physicians in non-clinical careers and can mean any number of things. In the contract research organization (CRO) world and pharma in general, a “Medical Director” typically is a physician who provides his/her medical knowledge and expertise to the day-to-day operations of clinical research studies. My company relies on my knowledge as a physician to answer medical questions from our study sites and our internal team. Common questions include:

  • This patient is having an adverse event to the study medication; has such an event been seen among other patients on the study? What do we do with the study medication – hold it, stop it, reduce the dose?
  • This patient has a pre-existing condition that might mean they are ineligible for this study. Please advise us on whether the patient may enroll in the trial given their condition.
  • This patient is supposed to be seen on day 10 of the study but can’t come because of a scheduling conflict. Will the protocol allow the patient to come a day later or a day earlier?
  • This study site is writing an informed consent form (ICF) and needs to know more about the study drug’s mechanism of action and potential side effects. Can you help us summarize what is known about the drug for the ICF?
  • This patient is taking medication x for y Is this drug allowed to be taken with the study drug?

Other duties include reviewing study data to look for trends and to ensure data are entered accurately from a medical perspective (e.g., a drug such as atorvastatin is entered in the record as being given for high cholesterol, not allergies). We use tools like Excel spreadsheets and other electronic data interrogation software to do this.

On many occasions, we are asked to provide input to our pharmaceutical company sponsors about the design of their study and how they can improve it to better recruit patients to the study. We help our sponsors and our internal team to find sites and principal investigators who are interested in conducting the studies. We help with business development activities, where we meet with sponsors who are in the process of selecting a CRO to run their study and want to know why they should choose us as their CRO partner (a meeting called a “bid defense”).

What is a typical day like?
One of the things I like best is that no day is exactly like another. In clinical medicine, every day felt the same – same number of patients to see each day, same cancer diagnoses, same drugs to prescribe, same types of questions to answer, over and over. Variety is the name of the game in my current job. I oversee about 7 to 10 studies, in a variety of different cancer types, and on any given day, I might work a little on each of the studies, or not at all on some but a lot on one or 2 others.

To give an example, some days I might be heavily involved in data review for one of my studies, other days are spent reviewing patient eligibility forms for a study and answering questions from a site, and some days preparing for upcoming bids and/or talking with a medical counterpart at a sponsor about how a study is going. Each day can be a mix of all these. I can work at my own pace. If I want to work in the morning, be available by phone but away from my computer for a while in the afternoon, and then go back to my computer to do work later into the evening, I can.

The job also involves a lot of conference calls over the Web, anywhere from 1 to 5 per day, for an hour or 2 each.

What do you like the most about your job?
The flexibility to work remotely and for the most part to set my own schedule. As long as I am available by phone for anything urgent, attend my conference calls, and get my work done, the day is mine to work in whatever else I need to.

What do you like the least about your job?
We often put a lot of time and effort getting ready to present our company and our ideas to a client when they are looking to hire a CRO, but we may not be selected to run the study. It sometimes seems like a lot of work for nothing.

What kind of transferable skills do you use from practicing as a physician?
Knowledge. What I am bringing to the table is my knowledge of Internal Medicine and Oncology as it is currently practiced in the US. The job allows me to fully use this skill that I spent years developing. I don’t have to worry about clerical tasks like entering orders into a computer or calling an insurance company, tasks that aren’t why I went into medicine to begin with and take away from one’s enjoyment of the profession.

What are some of the other roles that physicians have in your company or at a CRO in general?
Some physicians who did not pursue post-graduate training work as clinical research associates (CRAs) or project managers, roles in which they have a lot of hands-on responsibilities with the day-to-day operations of a trial. They might be visiting study sites to do monitoring (as a CRA), or overseeing the study as a project manager to ensure the various teams working on the study (data management, pharmacovigilance, medical monitoring, clinical operations, vendors) are operating within expected timelines and on budget.

Other physicians work in safety roles, where they primarily review serious adverse events that occur among patients enrolled in a study. They help write Investigator Brochures and annual reports to FDA that detail everything known about a drug in development, including what is known about the drug’s safety.

Do CROs hire primary care physicians, such as FP’s, internists, pediatricians, and OB/Gyns? Absolutely. Our company has a General Medicine Business Unit that employs medical directors with such backgrounds. We also have a few pediatric Hematologists/Oncologists who work on adult Hem/Onc studies.

Why go to a CRO for your first industry job instead of a pharmaceutical company?
There are pros and cons. A plus working for a CRO as a first industry job is that you get broad exposure to a lot of different drugs and drug company sponsors within a few short years. You get to see how different companies approach similar problems in different ways and gain valuable experience that way. A downside is that you are not just working on one drug or compound, and you don’t have the final word on how the study will be designed or carried out.

Working for a pharma sponsor, you will become intimately knowledgeable about the drug you are working on and know a lot about how the company you are working for approaches drug development from early phase to approval, but you might find the drug to which you are assigned not particularly interesting, or it could prove not effective and the project might end (meaning you will then be reassigned to another drug, or potentially terminated).

What kind of physician would do well in a CRO?
CROs typically like to hire physicians who have some background in research. It is not mandatory, but it would definitely help one’s chances of finding a job as a medical director at a CRO.

In addition to research experience, one needs to have good communication skills and be able to work in teams. We interact with a lot of different people, from those on our internal team to the study sponsor. Being able to communicate well is a must. We need to be able to explain medical concepts to those on our team with limited medical knowledge.

Flexibility is key. The drug companies we work with own the drugs, so ultimately they get to call the shots. We can advise our sponsors, but cannot dictate. So, it helps to have a personality that can adapt readily to change, e.g., if a sponsor wants to change the design of a study or rework the process of data review. We sometimes (not often) get asked to travel with very short notice, and that can be hard if you have obligations lined up. Flexibility and patience are virtues that serve a CRO physician well.

How is the compensation for a medical monitor at the medical director level?
Coming from academia, it was not a large drop in compensation when I transitioned to industry. I took about a 15% pay cut. It would have been a much larger decrease had I come from private practice. But to me, the cut was well worth the improved quality of life from not always feeling pulled in 20 directions every minute of every day at work.

A salary of $225 – $275 is a reasonable expectation at this time.

What can a physician do who does not have clinical trial/research experience to be a candidate for a CRO?
If you don’t have a lot of clinical trial experience or publications, position yourself as an expert in a particular area. Your clinical knowledge and expertise are what is most needed to develop and oversee clinical trials at a CRO. For example, if you are a primary care physician working in private practice, you may have extensive experience managing diabetes or hypertension; sell yourself as an expert in those areas. Another example would be a Neurologist in private practice who has treated a lot of dementia patients or MS patients; highlight your extensive experience managing patients with these diseases. A Vascular Surgeon might be able to highlight his/her experience with devices. Being able to tell a team what will and won’t work for a study because you have “been there, done that” in practice goes a long way.

Do you miss patient care?
At times, yes, but then I talk to my former colleagues who are still in the clinical world and I hear how things are only getting worse, not better. I know if I went back, I would still have the same frustrations and stress.

Anything else you would like to add?
I noticed within about 2 months of starting my new non-clinical career that I felt much more energetic. I no longer started my workday already feeling exhausted. I did not dread Monday morning anymore. I didn’t realize how run down I had gotten in my previous job. I don’t regret making the move at all.

A big thank you to Dr. Kelly Curtis for his excellent, in-depth interview! I hope you got a lot out of reading about his transition and what it’s like to work for a CRO.

If you missed the last blog post, Telemedicine as an Independent Contractor, you can read it here!

Be back soon,

Heather

 

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4 Comments

  1. Anu Jai on January 9, 2020 at 2:01 pm

    Thank you. Very inspiring.

    • Heather Fork on January 9, 2020 at 2:08 pm

      You’re most welcome. Thank you Anu, for reading and commenting!

  2. Navpreet Sahsi on February 25, 2020 at 6:57 am

    Fantastic blog. Thank you.

  3. Heather Fork on February 25, 2020 at 2:07 pm

    Thank you kindly for reading and for your enthusiastic feedback Navpreet! I will share your comment with Kelly Curtis. I’m glad you found the content valuable.

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