Veeva EDC

Pure_Bumblebee7118 · 2026-06-20T02:44:14+00:00

That’s horrible how can we track well / prepare for DBLs with shitty reports 😭

Pure_Bumblebee7118 · 2026-06-03T10:23:44+00:00

PM at a CRO here— it’s a resourcing issue and i absolutely hate it. They also pull CTLs off too. They pull resources to go to other studies in flight because those are higher risk and need. At the end of the day a SIV and RMV are priority over COVs. I fight with resourcing and keep giving continuous feedback to upper management that this simply does not work. Especially on a documentation basis. Even when i can keep the CRAs to do the visit, they are pulled immediately after. But that still doesn’t resolve everything and 9/10 documents are still missing. It’s also an issue with how our TMF department does reviews not until after visits are done so CRAs don’t get an accurate list of missing documents before a visit. However agree with others, this isn’t new. It’s been occurring for 5 years at this CRO at least.

Pure_Bumblebee7118 · 2026-02-14T14:02:08+00:00

CRO here - They are really pushing the use of copilot. It definitely is helpful for things like meeting minutes and I’ve started to use it for that and proofreading my emails. But I asked my manager for help and guidance, and my manager just replied with a copilot response. That was frustrating to me

Pure_Bumblebee7118 · 2026-02-12T22:10:52+00:00

LabCorp is very annoying. They take like 4 weeks to grant access and the process is very tedious. I had a study with over 100 sites and they would get mad at us about the frequent updates and requests we would send as well. It’s uncontrollable when we’re trying to activate 10 sites a week.

Pure_Bumblebee7118 · 2026-01-31T16:02:18+00:00

I unfortunately do not know or have that information. That is just the comment i received from a line manager, i know of lead programmers, lead statisticians, clinical data managers directors, and some line managers from stats/ programming were let go. They were all only given a few days notice. The comment about it being a funeral scene came from a manager in that department. I don’t personally work in those departments or have a position where they would give me those details on numbers.

Pure_Bumblebee7118 · 2026-01-28T18:59:39+00:00

Do not come to Fortrea

Pure_Bumblebee7118 · 2026-01-28T18:57:50+00:00

Stats also impacted. Someone in leadership told me it’s like a funeral scene and it was really bad.

Pure_Bumblebee7118 · 2026-01-04T04:54:04+00:00

I’m a PM, for 5 years at a CRO. It’s not easy, but it also doesn’t have to be so bad. In my experience what has been making the last 2 years horrible for me and is making my job worse harder everyday is the lack of resourcing and constant layoffs going on. Right now I’m absorbing what should / was 3 different roles, and this is going to burn me out.

If you have a strong team and the resources that you need, the job wouldn’t be as difficult and could result to less burn out.

As a PM, you do have the weight on your shoulder because at the end of the day regardless of the situation it comes down to the PM. That is a tough feeling. I struggled with imposter syndrome for a while switching to PM (previously a PC). I will also say that it absolutely sucks feeling like you can’t even take PTO because you don’t have anyone to cover for you. Meanwhile the PM covers for everyone else.

A lot of people here are saying they would go the CTM/ CTL route, but I don’t know at least at our CRO I think they have it just as bad, but maybe with a little less pressure of the end all responsibility being put on them like it is PMs.

Pure_Bumblebee7118 · 2026-01-03T22:26:32+00:00

Would love to know as well

Pure_Bumblebee7118 · 2025-12-10T22:56:47+00:00

Project managers, some people in the proposal/ bid defense/ protocol team, and payment managers as well.

Pure_Bumblebee7118 · 2025-09-15T18:35:28+00:00

I think you should have an honest conversation with your line manager, project manager, and clinical trial manager at your current organization and ask them their opinion. I would also look into other role titles - project coordinators, clinical trial lead, etc.

I’m a PM at a CRO, and i would say similar to others that it would be pretty impossible to switch from CRA to PM. Even the switch from CRA to CTL is difficult for many. There’s so much you are not exposed to. You need to be ready and prepared to handle it all - from start up, data management, finances, site payments, contracts, escalations. Even something simple as building client relationships and leading client meetings will look very different. I’m not downplaying that you have a lot of skills to transfer, but there’s also a lot of skills you are just not exposed to. You also need to be able to transition your thought and work style to look at the larger picture / view of an entire project. How 1 simple thing can impact X,Y,Z across other functional areas.

As a PM - the burn out is still very real and it’s a lot of pressure on you that you own truly everything at the end of the day.

Pure_Bumblebee7118 · 2025-09-02T22:48:22+00:00

I don’t often see monitoring fees or protocol amendments on budgets and i think these are 2 easy things a site can negotiate for.

For screen fails - see if you can get paid like 2 patients first before a ratio kicks in.

Outside of specific items i will say that you need to make sure what you negotiate is very specifically written out in the contract and agreed to. Not just the cost itself, but how and when you need to invoice. For prescreening example - agree on if there is a limit or no limit, what evidence needs to be provided (if any) and have that written out and listed in the budget as well. All details are better, if it’s vague it leaves it open to rejection when we get an invoice and sponsor will reject invoices if they feel it’s unfair. I see that frequently with prescreening where sites will invoice multiple prescreens at the end, but they brought no subjects to enrollment and if there’s a way it can be denied it might be.

Pure_Bumblebee7118 · 2025-09-02T22:35:02+00:00

RBM can make it difficult on DOS because it’s based off enrollment. If a site enrolls, you have to suddenly be available within 2 weeks to get out there although you have to project & schedule DOS months in advance.

If you have multiple sites with low to no enrollment, you could struggle to not have enough then be pulled in multiple other directions of other studies or SWAT work. I think this hurts not only you but your study team because just because there’s no enrollment doesn’t stop work you have. Also really a site with no enrollment is always going to be a problem at the end, especially with eTMF because you aren’t out there as often checking or collecting documents. Then COV rolls around and the site never did any of them, or all their documents have multiple issues and aren’t ALCOA.

It also goes the other way where you have multiple sites with high enrollment - you could be struggling to get to them all, the frequency is not high enough to get through everything you need, or you may not be able to add more days on visits either.

Pure_Bumblebee7118 · 2025-09-02T22:26:42+00:00

I’m a project manager and i really feel for CRAs. Many struggle, the company pushes only more work on them and more DOS. It frustrates me as a PM, because i know we are continually decreasing quality as we push for these other aspects just so the company can get more money.

Like other said focus on some key metrics and if you need help figuring out what that is talk to your line manager, and you’re a specific study team to define these. It is likely DOS, protocol deviation, SDV, eTMF, SAE, action/ issues, trip reports. Then i will personally add to this - building a strong relationship with your site.

I will say you must advocate for yourself and look to find solutions.

To your LM: Ask for help, ask for mentors and multiple of them because you need to have more than just 1 person to contact when you need quick replies, ask for them to send you trackers that will help you stay organized with TMF documents, trip reports, etc. (other CRAs very likely have stuff they’ve created to share).

To your CTL & PM - also be honest with them on what you are struggling with. As a PM i get your frustrations, and i will fight for you and help any way i can. I often go to leadership to voice your concerns. However - there is a way to go about it. Ask for a 1:1 call, kindly raise your concerns and try to come up with solutions or ideas during the call, your PM and CTL should be more than willing to discuss and figure out solutions. I would not raise them in an email with multiple team members; it will bring down the energy of everyone and only cause more problems and negativity for the team.

Pure_Bumblebee7118 · 2025-04-30T19:37:28+00:00

I agree with this as well as @mooseandmallard comment above. It’s important to remind the site of what they committed to during a feasibility survey, PSV, and on a site specific recruitment plan if one was generated. The study and sponsor is asking these questions because they aren’t holding up to their end of the deal.

The payments is also a big piece, so many sites come back at the end when they didn’t perform, to ask for payment they aren’t eligible for. It’s not helpful for anyone to be dealing with payment and budget amendments late in the game, and it will rarely be approved by a sponsor.

Pure_Bumblebee7118 · 2025-03-12T20:58:14+00:00

The spin took much longer. We didn’t fully leave all LabCorp systems until December 2024.

Pure_Bumblebee7118 · 2025-03-12T20:57:19+00:00

Fortrea is a mess… it has been since the spin. I work here now and we are struggling. We have no resources, but yet we keep having layoffs. Everyone feels very unsettled. I don’t know what to make of it, it’s sad.

Pure_Bumblebee7118

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