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Meet Shweta! 12 years ago, Shweta landed her first Life Sciences role as Clinical Trial Assi...
12 years ago, Shweta landed her first Life Sciences role as Clinical Trial Assistant. Since then, she’s worked her way through many career milestones within the clinical research sector, including overseeing several global clinical trials in real-world evidence.
At the beginning of this year, Shweta began her search for her next opportunity, one in a multinational organization where she could step up. Of course, we were on hand to support her each step of the way.
Since connecting with Jakk Pursey, explaining her goals and aspirations, Shweta’s now settled into her new role as Global Clinical Project Manager. We caught up with her to see how it’s going, what advice she has for others hoping to progress in clinical research, and how she found working with Meet during her job search.
As far as I can remember, I’ve always had an interest in Life Sciences in general.
When I was a student, I moved to the UK to complete a Bachelor’s degree in Pharmacy, then I did a couple of internships back home, and that’s when I truly knew that clinical research was something I was extremely interested in pursuing.
From there, I returned to the UK to complete my Master’s and began looking for a permanent position within clinical research. I was really fortunate to find something that I enjoyed early on.
It was really lovely. It was the beginning of the year when I knew that I was ready to move on from my previous role, but I wasn’t actively looking.
Once Jakk connected with me, it was like the perfect match. He listened to what I wanted out of a new role and then presented and explained the requirements of this role to me. From there, things started moving really quickly, which I wasn’t really expecting to begin with.
While I was going through the interview process, Jakk would catch up with me both before and after, and during the waiting period, he would regularly call and update me on any delays, assuring me he was in touch with their HR manager.
When you’re waiting for feedback after an interview, it’s the most tense time for any candidate. By keeping me in the loop of what was going on at that time, Jakk helped a lot. He really managed it all perfectly.
I had two offers, and I was extremely confused between the two trying to determine which would be right for me.
As I said, Jakk was very open and honest during the waiting period, and that was extremely helpful when it came to making my final decision. He was really sincere about the feedback I was receiving too, and it was the feedback that helped me make my final decision.
Not just that, but Jakk knew everything about the role. He told me all about how the organization works, how the team is structured, where I would be placed, and the scope for progression – not just vertically but horizontally too. Those opportunities are something that is extremely important to me, which again helped me make my decision.
Then finally, once the second offer was on the table, Jakk took the reigns and helped me negotiate salary and employee perks and so on. Overall, it was Jakk who made the offer all the more lucrative for me before I accepted.
After working at both, I think the major difference, or the most notable difference, is how the organization is structured. Because a multinational organization is already established, it already has set procedures in place regarding how we work. For startups, it’s an ongoing process where, in my experience at least, we were still writing and structuring our SOPs.
Having said that, multinational organizations still come with their own complexities. For example, at times, you might not be able to adhere to an SOP to run a trial, and so to tweak it, you’d require senior management’s approval.
Even though that might cause some minor hiccups, I feel like it does provide more structure to studies to have established SOPs in place. With time and experience, you might find yourself in a position to be able to tweak those procedures when necessary.
For me, after going from a small startup to a multinational company, it was a way of working I grew to prefer. That’s because when you work in these big organizations, you’re offered the opportunity to learn a lot on how to not only manage people but also manage huge multinational studies.
But who knows… Maybe further on in my career, I’ll change my mind and prefer to work for a smaller company where I can apply all these learnings from my time in bigger organizations.
I think if it’s possible and you have that sort of opportunity, then it’s certainly an experience you should gain. There are a lot of benefits to working in a larger company.
For me, when I was in working in a smaller organization, our partner CRO was multinational, and that’s where I ended up moving to. Because we already had a working relationship, it was a smooth transition.
I do realize that it’s not easy to get into these companies if you haven’t got prior experience working for one. It’s much different than working in a smaller startup size company. Having said that, my advice would be, if possible, to try it out at least once in your career. It will undoubtedly benefit you, your knowledge, and your career.
My favorite part of the job is that no two days are the same, mainly because multiple studies will usually be in different phases. That variation keeps the job exciting. For example, one study could be in the startup phase while another is in the closeout phase, and so the nature of the work you’re doing for each study is very different.
Of course, doing something different every day comes with its own challenges, but having the chance to work with various teams across the globe, you’re able to imbibe different cultures of working, and I find that really fascinating.
On top of that, I really enjoy public speaking and presenting, so that’s a bonus for me. In my role, I kind of become the face of multiple studies we’re working on because I interact with so many people, both internally and externally.
I definitely enjoy real-world evidence. It’s a phase of research that completely makes sense to me, but within time, when I’m ready, I definitely want to progress into another position.
Currently, working in a CRO is really enjoyable for me, and I plan on staying here for the foreseeable. At some point though, I would also like to try and move towards working for a sponsor organization and seeing what that’s like.
Real-world evidence studies are normally late-phase studies, so Phase IV, registry studies. What differentiates these from a normal clinical trial is that these drugs are already approved and on the market.
We collect data on how this drug is actually working in the real world. When a drug is available to the entire world’s population, we are able to see many differences in how it’s working between populations.
Obviously, clinical trials are very controlled, and when earlier phases of clinical trials are being conducted, we try to include all sorts of patients. With that said, it’s impossible to include every single variable in a clinical trial that could occur when a drug is rolled out across the entire globe.
In real-world studies, we’re able to actually capture that kind of data, noting the differences in how a drug would work on, let’s say, Japanese women in their 50s or men with cardiology-related disorders and so on.
For me, that’s the most interesting part. Because the drug has already gone through so many earlier phases of clinical trials, safety is not as much of a concern – and I say that with fingers crossed. But now we’re looking at how efficient that drug is across various populations.
It’s different depending on what studies I’m working on, but a lot of my experience has been in cardiovascular drugs and cardiovascular diseases.
For example, in my last position, we weren’t conducting drug-related research but rather disease-related research. We enrolled patients across 37 different countries who suffer from one particular cardiology disorder, atrial fibrillation.
From there, we were able to better understand the condition, exploring causes, symptoms, and treatments and ultimately improving care for people all around the world.
Recently I began working on a Managed Access Program (MAP), which is where a drug has not received approval across all of the different countries, but the drug is deemed to be very beneficial to a certain set of patients suffering from life-threatening diseases.
So, let’s say a drug that is useful for a cancer patient and has actually saved another patient’s life has not been approved in a particular country. In such cases, the physician who’s treating the patient, if they’re aware of this drug being developed, might directly contact the sponsor. In this case, they would be contacting the sponsor for us to request that drug for their patient.
As you can imagine, it’s an extremely regulated process because countries would not allow for a drug to be delivered to a physician in their country if it is not yet approved. But, if the drug has shown that it’s beneficial to this certain set of patients, these countries have rules and guidelines to approve that use as well.
A MAP works by helping the physician request the drug from the sponsor, the sponsor in getting that drug to that particular patient, as well as managing all the country’s guidelines and requirements.
MAPs have been around for a while, but they’re not very well known because of all the regulatory requirements and guidelines we need to adhere to. I’m really excited to be a part of that space, and I think it’ll be really fulfilling.
My only advice would be to keep yourself open to various opportunities within the organization you’re starting as a CTA.
Being a CTA is actually a very good place to begin because you can actually support a variety of teams working on a clinical trial. That helps you gain this overview of various different departments, how they function individually, and how they function together to reach the end result of a clinical trial.
Being a CTA was actually one of the roles where I learned the most in my whole career. That’s because I worked not only with the project management team, which I am now a part of, but a number of other functions too. For example, I worked very closely with data management helping them build the database, I collaborated with the events team to run investigator meetings, and I worked alongside the medical writing team to build publication plans and manage timelines.
When you’re in a position to support all kinds of different teams like that, you gain great insight into what they’re working on. That was what really helped me make up my mind when I first decided to go into project management because it's the part of clinical research that I enjoy the most.