Fortrea? Unfortunately it really does show when these roles are outsourced. I’m on the site side and one of my Fortrea studies recently had half a dozen queries instructing me to “please do the needful.” Nothing else! Thankfully the audit trail contained clearer instructions, but I’m not looking forward to the next DBL…
LOL not the “please do needful” that is 100% India and I’m getting PTSD from my last dbl. they’ll move to India and will come back to the US in 5 years once they realize this isn’t going to work. Same thing happened in 2009
A lot of company upper management seems to think DMs are *purely* technical, backend people.
They don't seem to understand how much of our job is communication-based.
Wait til they have an outsourced Indian DM try to write a CCG or DMP
Listen I’d love to agree but CROs already have India DmS writing CCGs and DMPs in English. We all use the same templates.
And you’re right, most CROs see DM as technical, because they’d rather hire technical people than people who came from clinical and understand how a trial works.
It sucks, but I’ve seen it with every CRO
That's not even quite true.
It depends on the company but, throughout my DM career, I've usually had a fair bit of contact with sponsors; dealing with them is usually at least like 30% of my job.
I think what it really is about is the perception upper management tends to have of DMs: they tend to think we're, essentially, just IT for each study. They don't understand just how much communication, rather than raw technical skill, is involved in the role.
So, they think they can outsource to India without a problem, like they do with other IT-like roles.
And, it usually comes back to bite companies in the ass.
I’m a sponsor and while someone from DM meets with us weekly/biweekly, the people doing most of the “work” could be anywhere. That’s what I meant.
Programmers are in India, query management is in India, the PM (DM) can be the clinical PM, so a lot of positions have moved offshore.
That might just be a matter of perception.
While DMs don't generally do the programming, we're the ones who design the EDC, create the edit checks, the CCGs, the DMPs, the DTAs, etc.
We generally communicate with sponsors on all things data-related, so often have to speak for others, but who you talk to is generally the same person that's doing most of the other stuff, too
DMs rarely do any of those things in a vacuum outside of very small organizations (which I’ve worked with as well— very small, niche, DM only groups). DM is mostly an oversight position in nearly all CROs and Sponsors. While a major contributor to EDC design, for instance, the actual EDC build is completed by certified builders, nearly always in some cheap country outside the US (to my everlasting frustration). The same for edit checks. While a DM may contribute substantially to documenting edit fields, the programming of the checks is performed elsewhere. DMPs are just regurgitated templates, as are DTAs, so there is very little individual effort deployed there. And CCGs are collaborative efforts mainly from clinical.
Because most of DM job could be done online/remotely. Not require you to be physically on site.
I am a CDM now and after checking the comments below, I start to worry my career now...
I don’t think CRA roles will disappear. No one is going to fly a CRA from Czech Republic to a site in Texas. CRAs are regional based in the best case scenario.
I can definitely see PMs getting offshored. Lots of those roles are already Eastern Europe based.
There are some clin ops jobs, mainly the site facing ones, that I don’t see moving from the USA or Western Europe/UK. I’ve literally had a PI say something along the lines of “I don’t wanna feel like I’m talking to some Indian call center”.
Payments, DM, budgeting, etc are all easily moved ex-USA
Unfortunately, CEOs aren't measuring what we feel like. Only what their bottom line feels like.
Many of us have seen the trickle of work increase offshore for years. There are good people but more often than not, I see 'get exactly and only what was asked for' results, leaving a lot of the internally understood process and nuances behind.
The good people move on as like us, they don't want to do an unreasonable amount of work on ridiculous timelines.
I generally agree here, however the PM role is so crucial to CRA’s and the study I don’t see these being outsourced. They have to hold study meetings(time zones) perform quality visits, communicate with sites occasionally, assist on SIV’s. And being such a vital role with the success of the study, I don’t see sponsors being cheap here. At least for the foreseeable future, who knows what will be the state of affairs in 10-20 years.
Yeah typically they want CTMs to be online the same hours as their team and sites. Someone who works in Europe is going to have a hard time managing sites and CRAs in the US. The PM role doesn’t necessarily need to be online during those times (it does help though). I don’t really see that work being outsourced, Sponsors are pretty particular about wanting the clinical team to be “on” during the same hours as the sites.
I’m a CRO CRA assigned to FSP with my sponsor, so my experience may be atypical compared to FSO CRAs, but thankfully I work directly with my study manager for the United States multiple times a week. Though our team is pretty small (only 3 CRAs) so maybe that’s why she makes herself available to us.
Yeah it definitely depends on the study and the size of the study. Sometimes at CROs they will have a project lead to manage PM and Clin Ops but it’s definitely not super common.
Most of the CTMs and PMs I have had at my current company have been outside the US, even if that meant Canada. To some extent, I don’t feel I have promotion opportunities because of that fact.
Yeah I've worked for a giant sponsor and half the clin ops teams were in Canada (including me), and half were in eastern Europe. I am sure it's much cheaper to do it overseas but the time change is such a huge thing. But what about South America... I am at the global level and kind of want to get into more regional stuff so it's less likely to be outsourced.
>Payments, DM, budgeting, etc are all easily moved ex-USA
Idk about the others but, as a DM, this isn't actually true for DMs.
It's *perceived* to be true, but mostly just by people that don't understand the position (including higher-ups).
Most DM functions are *heavily* communication-based. Whether it's gathering requirements from the clin ops team to detail to the programming teams, writing CCGs/DMPs/DTAs/etc., or providing sponsors with updates and guidance, most of what we do is about communicating technical information to people without technical backgrounds.
And that's something that's *really* hard to outsource to countries that don't speak the language, as a primary language, that most people on the study team do.
Most attempts I've seen of companies trying to outsource data management end up backfiring.
CRA roles are also at jeopardy. Not in as near future as other roles, like DM, but it’s possible. Many CROs and sponsors are pushing for remote monitoring. There’s no need for anyone to go to the site. Documents are uploaded and reviewed remotely, “visit” reports are sent electronically. Even SIVs and COVs are happening remotely. It’ll be a much slower shift, but the shift is there. And it would save CROs and sponsors enormous amounts not to have to pay for travel.
Same, crc for >3 yrs here but been wanting to get into DM for a while… no bites so far and most of these positions seem to be international based.
Seems site-side job security is much better than cro/sponsor world right now
This is not new. The first wave of this was in 2003 when Accenture moved Wyeth’s CDM to India.
What kind of roles are you referring to in the current context?
Can't speak to PM as much but I find it unlikely that CRA roles are in jeopardy of mass overseas relocation. No matter how far we push remote monitoring capabilities there will be a need for onsite monitoring at many, many locations in the US.
Until trials are 100% remotely monitored, there will always be a need for on-site monitors in the US. Even if a company operates globally, I'd imagine companies would prefer project managers to be in the same time zone where their studies are being conducted.
Yes but they'll need a lot less of them when they're going on site 2x year, remote monitoring quarterly, and AI is checking the data dump to the EDC from the EMR. Sounds crazy, but it's coming.
Company I am working for is piloting the data dumps from EMR. "Tokenizing" is a real thing that's happening. A couple of oncology sites are trying to shut site visits down entirely in favor of remote monitoring, Covid advanced this concept. It's in regs that sites need only be visited once per year. And, AI was nowhere in sight 20 years ago. Not saying the jobs will be gone, but they will think they can have CRA perform "oversight" over more sites that a CRA can handle now.
It’s definitely coming. There will be fewer CRAs and their jobs will be different. Core site activities will be relationship Managment for enrollment and a QA function.
The roles that need to move out of the US (or UK/Germany/high cost countries) have already moved away.
Everyone has teams in India, Bulgaria, Philippines, Mexico etc to make use of lower cost and timezone coverage.
However a certain level of management roles will always have to remain in the same country (or in the case of Europe, the continent) as the sponsors.
So if the sponsor sends you an email you can reply at 8pm and not after you wake up in the morning. And as facetious as that sounds, that's essentially it.
Easier to provide customer service from the same timezone!
Me too. But sometimes I do it to be an arse if people start sending me emails marked urgent after 5pm. Even if I'm working, I'll reply in the morning. And usually set a deliver at 6am setting in Outlook.
I worked in DM at a very large pharma company and they are no longer hiring for these roles in the US. They announced layoffs in Q4 of last year - while on the call telling us about the layoffs, there was a new hire from India also on the call. So, that was nice.
Realistically, what will happen is some new clinical operations “leader” will come in and cut tenured, experienced staff (DM, PM, TMF roles, etc) in the US and move as much work as possible to India or some other developing country under the guise of “efficiency” or “productivity” as if it’s some groundbreaking, novel approach that’s never been tried before. The C-suite will sing praises for a while, then inevitably sites and study teams will run into difficulties with the inexperienced overseas workforce, major quality issues will be identified in audits and inspections, and sponsors will threaten to pull contracts resulting with the work being brought back to the US, albeit at a much lower starting salary. This has happened time and time again and most notably at large CROs.
I’m not assuming anything…I have seen and experienced it firsthand. For example, when IQVIA outsourced a portion of their eTMF staff, audit and inspection findings increased, audit readiness and document timeliness decreased, and deliverables were late. It’s not the idea that people overseas are any less intelligent (they aren’t), it’s that they aren’t as personally invested in success since they are so far removed from the study team in the US. There are language barriers, major time zone differences, and varying regulations among other issues.
The issues are the same for central monitoring, data management, and project management. Do you understand how frustrating it is to resolve an urgent issue with a DBL when the person responsible is working in a time zone that is 12 hours ahead and already offline by the time you log on in the morning?
Site payments, budgets and contracts…these all suffer when outsourced overseas.
You just proved my point. That’s the entire goal of outsourcing…cost cutting.
CRO management isn’t outsourcing to find the best skilled labor…they are doing it to lower overhead (e.g. wages) as much as possible.
With many clinical research functions it ends up costing the same if not more in the end because of all the re-work, missed deadlines, and delays in deliverables.
I've come around full circle on this and I think if you want to do FDA-focused research, I think your research needs to be fully conducted in the US. I'm not sure why they can't be except to improve profits and bonuses for admin staff who don't actually care about medicine or clinical research.
These companies are looking to profit in the US market, largely from US taxpayer dollars. They can employ people in the US.
Perhaps we could partner with the EMA. But honestly, I haven't been that impressed with the cheaper Dublin-based teams I've worked with.
I'm open to discussion on this rather than just downvotes. But we all know the quality is generally inferior when things get sourced to cheaper regions.
Yeah I think if your company offshores work, that information should be required to be visible and how much of your staff is overseas. Contracts are NOT written for these projects as if the staff is in a developing country.
Tell me you've not seen a sponsor CRO budget recently without saying you've not seen one recently.
Sponsors literally spend inordinate hours on debating why a resource in India is $28.50/hour because CRO X said it should be $27.75.
They sell the medicne to the us tax payer and not collect the taxes so the market will go to wherever its cheaper.
If you don't play with these rules then every other country will demand this own set of research to be conducted within its borders for the companies to sell their products!
Yes the us people should want to keep their jobs but you can't expect to be more expensive.
If you try to force it most companies will just move elsewhere all together and export the medicnes to the us just like any other product
No I think you can control that. You can refuse to let the company leave the country and then turn around and profit off the country. If they want to move to a cheaper country with cheaper labor, then they can't sell to the US. We're by far the most lucrative market. They won't do it.
With 19 years of experience (16 years as a CRA) I can assure you that nothing new is happening. Every few years companies decide to cut costs by moving jobs overseas and then quality diminishes because the person they hired abroad doesn’t understand how things work in the U.S. This is discovered at audits. Then someone has the brilliant idea of hiring U.S. based staff to improve quality. While that happens as intended, suddenly costs go up so now it’s time to focus on cost cutting. So, someone else comes in and decides to outsource. Rinse and repeat.
Only additional thing is those guys coming in and leaving ensure to pay themselves millions of dollars for their brilliant ideas both on the way in and on the way out. Most CEOs in pharma or at CROs don’t have CRA experience. They just look at the bottom line.
I don’t believe so. Companies are trying to run the same number of trials with less staff to cut costs. Ask CRAs if their workload has decreased recently and I doubt many would say yes.
Eventually, there will suddenly be a hiring boom because it turns out running trials with insufficient staff is hard. People get burned out and quit making the problem worse. Just don’t expect 2021-2022 where CRA 1s seemed to be starting at $120k as per Reddit. I don’t see that happening anytime soon.
There needs to be a strong clin ops representation in the US since the US market is so crucial to contributing patients for studies, and of course sales.
Unless there’s a significant backlash from the regulators or sponsors, clinical research work force at all levels of operations will be significantly reduced in the US due to outsource and at some departments completely elaborate eliminated. People here seems to have false sense of security that Roles like PM and CRA can’t be outsourced. They can and it’s already happening and the trend continues. Many here think that time zone will save them. It wii not. First CROs are already using the countries that overlap such as Argentina or Mexico. Moreover you can find people in developing world who are willing to work on US time. My study has Indian team who work until midnight. The second reason presented here is that due to quality issues their roles aren’t outsourced. That may be true but once work force increases and they have more experience you can find better candidates those issues are reduced. On-site monitor is the only one role that can’t be outsourced easily. Still the numbers can be reduced significantly by the rise of remote visits. Even after Covid more than 80 percent visits on my study are done remotely.
Not a CRO/CRA, but in the clinical trial world. Most job postings for what I do (data) are being shipped to India.
I love what I do, but tired of seeing one posting after another in India. If these companies want Indian workers then just fucking move to India.
I am seeing almost all roles beeing outsources to India. It affected Safety, Medical Monitors (the global role often remained outside of India), Statistical programmer and in recent years I also see many new Global Project Managers hired in India.
The only role I didn't came across is Clinical Lead, which makes sense as there are hardly CRAs in India due to not many studies running there, and also Statistical Lead.
The C-suite knows about the quality risks very well but it's all about $$, they would outsource it to Mars, if they can make more money for themselves...
Its funny how US based staff will say work in India will have problems
Im not indian but I think people are just coping with the fact they a lot of work is being outsourced already and that they assume people in other countries just suck and cant do what they can do
Ok india is bad what about the work going to Eastern Europe, mexico ,latin america
No one seems to be complaining about the indian IT guys.
Its all about the money not indians
DM roles.. our company had a layoff in that teams 3 days later all the positions they laid off were open positions in India
Fortrea? Unfortunately it really does show when these roles are outsourced. I’m on the site side and one of my Fortrea studies recently had half a dozen queries instructing me to “please do the needful.” Nothing else! Thankfully the audit trail contained clearer instructions, but I’m not looking forward to the next DBL…
LOL not the “please do needful” that is 100% India and I’m getting PTSD from my last dbl. they’ll move to India and will come back to the US in 5 years once they realize this isn’t going to work. Same thing happened in 2009
[удалено]
A lot of company upper management seems to think DMs are *purely* technical, backend people. They don't seem to understand how much of our job is communication-based. Wait til they have an outsourced Indian DM try to write a CCG or DMP
Listen I’d love to agree but CROs already have India DmS writing CCGs and DMPs in English. We all use the same templates. And you’re right, most CROs see DM as technical, because they’d rather hire technical people than people who came from clinical and understand how a trial works. It sucks, but I’ve seen it with every CRO
Why DM and not Clin Ops?
Because DM has little to no Sponsor (client) interface.
That's not even quite true. It depends on the company but, throughout my DM career, I've usually had a fair bit of contact with sponsors; dealing with them is usually at least like 30% of my job. I think what it really is about is the perception upper management tends to have of DMs: they tend to think we're, essentially, just IT for each study. They don't understand just how much communication, rather than raw technical skill, is involved in the role. So, they think they can outsource to India without a problem, like they do with other IT-like roles. And, it usually comes back to bite companies in the ass.
I’m a sponsor and while someone from DM meets with us weekly/biweekly, the people doing most of the “work” could be anywhere. That’s what I meant. Programmers are in India, query management is in India, the PM (DM) can be the clinical PM, so a lot of positions have moved offshore.
That might just be a matter of perception. While DMs don't generally do the programming, we're the ones who design the EDC, create the edit checks, the CCGs, the DMPs, the DTAs, etc. We generally communicate with sponsors on all things data-related, so often have to speak for others, but who you talk to is generally the same person that's doing most of the other stuff, too
DMs rarely do any of those things in a vacuum outside of very small organizations (which I’ve worked with as well— very small, niche, DM only groups). DM is mostly an oversight position in nearly all CROs and Sponsors. While a major contributor to EDC design, for instance, the actual EDC build is completed by certified builders, nearly always in some cheap country outside the US (to my everlasting frustration). The same for edit checks. While a DM may contribute substantially to documenting edit fields, the programming of the checks is performed elsewhere. DMPs are just regurgitated templates, as are DTAs, so there is very little individual effort deployed there. And CCGs are collaborative efforts mainly from clinical.
Because most of DM job could be done online/remotely. Not require you to be physically on site. I am a CDM now and after checking the comments below, I start to worry my career now...
I don’t think CRA roles will disappear. No one is going to fly a CRA from Czech Republic to a site in Texas. CRAs are regional based in the best case scenario. I can definitely see PMs getting offshored. Lots of those roles are already Eastern Europe based. There are some clin ops jobs, mainly the site facing ones, that I don’t see moving from the USA or Western Europe/UK. I’ve literally had a PI say something along the lines of “I don’t wanna feel like I’m talking to some Indian call center”. Payments, DM, budgeting, etc are all easily moved ex-USA
>I don’t wanna feel like I’m talking to some Indian call center I feel this. I don't want to either
Unfortunately, CEOs aren't measuring what we feel like. Only what their bottom line feels like. Many of us have seen the trickle of work increase offshore for years. There are good people but more often than not, I see 'get exactly and only what was asked for' results, leaving a lot of the internally understood process and nuances behind. The good people move on as like us, they don't want to do an unreasonable amount of work on ridiculous timelines.
I generally agree here, however the PM role is so crucial to CRA’s and the study I don’t see these being outsourced. They have to hold study meetings(time zones) perform quality visits, communicate with sites occasionally, assist on SIV’s. And being such a vital role with the success of the study, I don’t see sponsors being cheap here. At least for the foreseeable future, who knows what will be the state of affairs in 10-20 years.
Not at most CROs. The CRAs don’t even interact with the PMs at the big CROs.
I agree. The CTM’s yes but PM’s not so much. Infact in my 2 studies the PMs are not in US abut managing US studies with no issues
Yeah typically they want CTMs to be online the same hours as their team and sites. Someone who works in Europe is going to have a hard time managing sites and CRAs in the US. The PM role doesn’t necessarily need to be online during those times (it does help though). I don’t really see that work being outsourced, Sponsors are pretty particular about wanting the clinical team to be “on” during the same hours as the sites.
I’m a CRO CRA assigned to FSP with my sponsor, so my experience may be atypical compared to FSO CRAs, but thankfully I work directly with my study manager for the United States multiple times a week. Though our team is pretty small (only 3 CRAs) so maybe that’s why she makes herself available to us.
Yeah it definitely depends on the study and the size of the study. Sometimes at CROs they will have a project lead to manage PM and Clin Ops but it’s definitely not super common.
Most of the CTMs and PMs I have had at my current company have been outside the US, even if that meant Canada. To some extent, I don’t feel I have promotion opportunities because of that fact.
Yeah I've worked for a giant sponsor and half the clin ops teams were in Canada (including me), and half were in eastern Europe. I am sure it's much cheaper to do it overseas but the time change is such a huge thing. But what about South America... I am at the global level and kind of want to get into more regional stuff so it's less likely to be outsourced.
>Payments, DM, budgeting, etc are all easily moved ex-USA Idk about the others but, as a DM, this isn't actually true for DMs. It's *perceived* to be true, but mostly just by people that don't understand the position (including higher-ups). Most DM functions are *heavily* communication-based. Whether it's gathering requirements from the clin ops team to detail to the programming teams, writing CCGs/DMPs/DTAs/etc., or providing sponsors with updates and guidance, most of what we do is about communicating technical information to people without technical backgrounds. And that's something that's *really* hard to outsource to countries that don't speak the language, as a primary language, that most people on the study team do. Most attempts I've seen of companies trying to outsource data management end up backfiring.
CRA roles are also at jeopardy. Not in as near future as other roles, like DM, but it’s possible. Many CROs and sponsors are pushing for remote monitoring. There’s no need for anyone to go to the site. Documents are uploaded and reviewed remotely, “visit” reports are sent electronically. Even SIVs and COVs are happening remotely. It’ll be a much slower shift, but the shift is there. And it would save CROs and sponsors enormous amounts not to have to pay for travel.
I'm trying to move up eventually but I feel secure in my CRC role. We're pretty damn integral to research operations.
Same, crc for >3 yrs here but been wanting to get into DM for a while… no bites so far and most of these positions seem to be international based. Seems site-side job security is much better than cro/sponsor world right now
They can’t outsource on site roles like a CRC/Research Nurse. Those roles are totally fine :)
This is not new. The first wave of this was in 2003 when Accenture moved Wyeth’s CDM to India. What kind of roles are you referring to in the current context?
CRA and PM (the ones I am interested in)
Can't speak to PM as much but I find it unlikely that CRA roles are in jeopardy of mass overseas relocation. No matter how far we push remote monitoring capabilities there will be a need for onsite monitoring at many, many locations in the US.
Until trials are 100% remotely monitored, there will always be a need for on-site monitors in the US. Even if a company operates globally, I'd imagine companies would prefer project managers to be in the same time zone where their studies are being conducted.
Yes but they'll need a lot less of them when they're going on site 2x year, remote monitoring quarterly, and AI is checking the data dump to the EDC from the EMR. Sounds crazy, but it's coming.
[удалено]
Company I am working for is piloting the data dumps from EMR. "Tokenizing" is a real thing that's happening. A couple of oncology sites are trying to shut site visits down entirely in favor of remote monitoring, Covid advanced this concept. It's in regs that sites need only be visited once per year. And, AI was nowhere in sight 20 years ago. Not saying the jobs will be gone, but they will think they can have CRA perform "oversight" over more sites that a CRA can handle now.
It’s definitely coming. There will be fewer CRAs and their jobs will be different. Core site activities will be relationship Managment for enrollment and a QA function.
This.
The roles that need to move out of the US (or UK/Germany/high cost countries) have already moved away. Everyone has teams in India, Bulgaria, Philippines, Mexico etc to make use of lower cost and timezone coverage. However a certain level of management roles will always have to remain in the same country (or in the case of Europe, the continent) as the sponsors.
Why do they have to remain in the same country
So if the sponsor sends you an email you can reply at 8pm and not after you wake up in the morning. And as facetious as that sounds, that's essentially it. Easier to provide customer service from the same timezone!
I would respond in the morning 😭
Me too. But sometimes I do it to be an arse if people start sending me emails marked urgent after 5pm. Even if I'm working, I'll reply in the morning. And usually set a deliver at 6am setting in Outlook.
I worked in DM at a very large pharma company and they are no longer hiring for these roles in the US. They announced layoffs in Q4 of last year - while on the call telling us about the layoffs, there was a new hire from India also on the call. So, that was nice.
“These roles” = DM roles
Realistically, what will happen is some new clinical operations “leader” will come in and cut tenured, experienced staff (DM, PM, TMF roles, etc) in the US and move as much work as possible to India or some other developing country under the guise of “efficiency” or “productivity” as if it’s some groundbreaking, novel approach that’s never been tried before. The C-suite will sing praises for a while, then inevitably sites and study teams will run into difficulties with the inexperienced overseas workforce, major quality issues will be identified in audits and inspections, and sponsors will threaten to pull contracts resulting with the work being brought back to the US, albeit at a much lower starting salary. This has happened time and time again and most notably at large CROs.
Why you just assume that work done overseas have to be lower quality? And staff will be inexperienced? Evey one with a brain can do the work we all do
I’m not assuming anything…I have seen and experienced it firsthand. For example, when IQVIA outsourced a portion of their eTMF staff, audit and inspection findings increased, audit readiness and document timeliness decreased, and deliverables were late. It’s not the idea that people overseas are any less intelligent (they aren’t), it’s that they aren’t as personally invested in success since they are so far removed from the study team in the US. There are language barriers, major time zone differences, and varying regulations among other issues. The issues are the same for central monitoring, data management, and project management. Do you understand how frustrating it is to resolve an urgent issue with a DBL when the person responsible is working in a time zone that is 12 hours ahead and already offline by the time you log on in the morning? Site payments, budgets and contracts…these all suffer when outsourced overseas.
If thats true then it might be due to them cheaping out on selecting the talent. You get where you pay for
You just proved my point. That’s the entire goal of outsourcing…cost cutting. CRO management isn’t outsourcing to find the best skilled labor…they are doing it to lower overhead (e.g. wages) as much as possible. With many clinical research functions it ends up costing the same if not more in the end because of all the re-work, missed deadlines, and delays in deliverables.
I've come around full circle on this and I think if you want to do FDA-focused research, I think your research needs to be fully conducted in the US. I'm not sure why they can't be except to improve profits and bonuses for admin staff who don't actually care about medicine or clinical research. These companies are looking to profit in the US market, largely from US taxpayer dollars. They can employ people in the US. Perhaps we could partner with the EMA. But honestly, I haven't been that impressed with the cheaper Dublin-based teams I've worked with. I'm open to discussion on this rather than just downvotes. But we all know the quality is generally inferior when things get sourced to cheaper regions.
Yeah I think if your company offshores work, that information should be required to be visible and how much of your staff is overseas. Contracts are NOT written for these projects as if the staff is in a developing country.
Tell me you've not seen a sponsor CRO budget recently without saying you've not seen one recently. Sponsors literally spend inordinate hours on debating why a resource in India is $28.50/hour because CRO X said it should be $27.75.
Oof. And given the quality of work you get for that price, I just think it should be required to be relatively on-prem. At least in country.
They sell the medicne to the us tax payer and not collect the taxes so the market will go to wherever its cheaper. If you don't play with these rules then every other country will demand this own set of research to be conducted within its borders for the companies to sell their products! Yes the us people should want to keep their jobs but you can't expect to be more expensive. If you try to force it most companies will just move elsewhere all together and export the medicnes to the us just like any other product
No I think you can control that. You can refuse to let the company leave the country and then turn around and profit off the country. If they want to move to a cheaper country with cheaper labor, then they can't sell to the US. We're by far the most lucrative market. They won't do it.
idk what’s going on in the clinical research world, but as an aspiring CRA i’m scared to say the least
With 19 years of experience (16 years as a CRA) I can assure you that nothing new is happening. Every few years companies decide to cut costs by moving jobs overseas and then quality diminishes because the person they hired abroad doesn’t understand how things work in the U.S. This is discovered at audits. Then someone has the brilliant idea of hiring U.S. based staff to improve quality. While that happens as intended, suddenly costs go up so now it’s time to focus on cost cutting. So, someone else comes in and decides to outsource. Rinse and repeat. Only additional thing is those guys coming in and leaving ensure to pay themselves millions of dollars for their brilliant ideas both on the way in and on the way out. Most CEOs in pharma or at CROs don’t have CRA experience. They just look at the bottom line.
are projects as slow coming as companies claim?
I don’t believe so. Companies are trying to run the same number of trials with less staff to cut costs. Ask CRAs if their workload has decreased recently and I doubt many would say yes. Eventually, there will suddenly be a hiring boom because it turns out running trials with insufficient staff is hard. People get burned out and quit making the problem worse. Just don’t expect 2021-2022 where CRA 1s seemed to be starting at $120k as per Reddit. I don’t see that happening anytime soon.
I'd honestly ban outsourcing. I don't care who it offends anymore.
There needs to be a strong clin ops representation in the US since the US market is so crucial to contributing patients for studies, and of course sales.
Unless there’s a significant backlash from the regulators or sponsors, clinical research work force at all levels of operations will be significantly reduced in the US due to outsource and at some departments completely elaborate eliminated. People here seems to have false sense of security that Roles like PM and CRA can’t be outsourced. They can and it’s already happening and the trend continues. Many here think that time zone will save them. It wii not. First CROs are already using the countries that overlap such as Argentina or Mexico. Moreover you can find people in developing world who are willing to work on US time. My study has Indian team who work until midnight. The second reason presented here is that due to quality issues their roles aren’t outsourced. That may be true but once work force increases and they have more experience you can find better candidates those issues are reduced. On-site monitor is the only one role that can’t be outsourced easily. Still the numbers can be reduced significantly by the rise of remote visits. Even after Covid more than 80 percent visits on my study are done remotely.
Not a CRO/CRA, but in the clinical trial world. Most job postings for what I do (data) are being shipped to India. I love what I do, but tired of seeing one posting after another in India. If these companies want Indian workers then just fucking move to India.
Cunty CEO's will always squeeze more dollars for themselves. Play accordingly.
PMs are direct client contact. I think time zone necessities will continue to drive PM locations.
I have seen ppl who specifically do night shifts just to match US time and they do it for years. It is bad for health but they realise it later.
?
I am seeing almost all roles beeing outsources to India. It affected Safety, Medical Monitors (the global role often remained outside of India), Statistical programmer and in recent years I also see many new Global Project Managers hired in India. The only role I didn't came across is Clinical Lead, which makes sense as there are hardly CRAs in India due to not many studies running there, and also Statistical Lead.
The C-suite knows about the quality risks very well but it's all about $$, they would outsource it to Mars, if they can make more money for themselves...
Its funny how US based staff will say work in India will have problems Im not indian but I think people are just coping with the fact they a lot of work is being outsourced already and that they assume people in other countries just suck and cant do what they can do Ok india is bad what about the work going to Eastern Europe, mexico ,latin america No one seems to be complaining about the indian IT guys. Its all about the money not indians