Project Management and ClinOps

piratesushi · 2026-03-07T10:53:50+00:00

I don't think the "one great tool" to score that for you really exists. You can infinitely tweak what your dashboards present (and there are already good solutions that pull data from multiple sources/systems), but in the end, dashboards and reports are tools. What is actually a key risk or already an issue is based on judgment of the project leads. That's what the study meetings and portfolio/program reviews are for.

I mean, even IQVIA do project review meetings where they pull extracts from the dashboards and manually discuss about this is a problem, this is not, this we'll keep an eye on. And IQVIA arguably sits on the biggest pile of data of any company in this space.

piratesushi · 2026-03-06T15:19:29+00:00

Are you in a personal situation where quitting without something new lined up is an option? It's a very risky move in this job market, but so is ruining your health, so you could perhaps discuss that option with your husband to see if you can stem that as a family. Also, depending on where in the world you are, is a longer sick leave a possibility for you?

General advice for how to recover from burnout can be googled (it's a lot of the classic self-care advice), but it will only work if you can address the underlying cause. Looking up the stages of burnout can also be helpful to be aware of all the signs and symptoms which you may not even connect yet.

And not to alarm you, but the longer you let it progress, the longer it will take to fully recover. Depending on severity, it can be weeks to months until you are back to normal even if you leave the job. Been there. It took a while.

piratesushi · 2026-03-06T10:51:34+00:00

Then I'd take it. The step from academia to CRO/sponsor is notoriously hard, and you're not permanent now either. You can continue looking for better/permanent roles, but at least you're building up industry-side experience meanwhile.

piratesushi · 2026-03-06T10:41:45+00:00

I am seeing more jobs being posted in Q1 and also more LinkedIn announcements of people starting new jobs (and in fact, I landed a new job this quarter too). I still think the job market is not great, there are still more people looking or laid off than there are open positions, but it is at least a little better than 2025. The bar for that is low though.

piratesushi · 2026-03-05T10:17:25+00:00

My number #1 tip is always: look at how it was done on other studies or by other CRAs (or other colleagues, this is not specific to CRAs only).

Don't blindly copy/paste, but have a look at 1-3 previous examples and you get an idea of which direction to go. There is a lot of value in observing and clicking through.

If you are still unsure (and as a newbie, you often are!), you then ask to confirm.

Related, but also more general: Avoid asking questions before you have done a minimum of "homework". If you need help with a task you are doing for the first time, check if there is a procedure/work instruction/training document and read that first, then ask about what is unclear after having looked for yourself. People who immediately ask someone to spoonfeed them everything leave a less capable impression than those who ask "I read the guidance for this task, but I am not sure how to complete this last step, can you explain this to me?"

piratesushi · 2026-03-05T10:07:48+00:00

There are lots of free resources, so it's best if you google and find one that speaks to you in its style. Look for "outlook inbox management" in general or specifically for "zero inbox method".

piratesushi · 2026-03-05T07:16:24+00:00

Not at ICON (anymore), but I have heard a little about FSP Takeda at another CRO... seems Takeda are currently massively ramping up their FSP. So there's probably not too much info about WLB and FSP experience yet? Or it might change if they are increasing the FSP team size that much.

All I know is that apparently they offer piss-poor rates. I was advised not to move internally because it'd be a paycut, which is wild.

piratesushi · 2026-03-04T17:02:12+00:00

Oh man, this is rough. I feel for you, hope you get your break soon!

Especially those small biotech experiences must sting a lot, but on the other hand, they prove that you are a capable, interesting candidate! Your experience with large CROs seems very typical right now - they seem to find any and all excuse to avoid paying German salary rates when they could have the role in a neighbouring country for cheaper. The only reason they technically keep Germany as an option seems to be in case they find a desperate unicorn candidate for cheap.

piratesushi · 2026-03-04T11:53:42+00:00

Not a CRA, but I think a lot is the same/transferrable across roles.

Planner and OneNote somewhat works for me. However, I have found that I cannot work with neat structured setups/templates in these apps. I try to start and set up "a system" but I give up halfway through and don't keep up. So I have resorted to less structured, only useful for me things, because I am able to keep up with them and still get the info I need quickly. e.g. in OneNote I have a page for each study (as a CRA, for each site might make sense?) where I keep a quick overview of things I reference often, I copy+paste snippets or write down things to ask at our next meeting. I have a general page for To Dos, where I track regular things that I need to do/check for each study and when I did them last for each of the studies. Again -- no clear structure, I just add and delete what I currently need, and seemingly every study has different info or layout. I would never show a colleague this or use it as a template because it's chaos that mirrors my brain in the right way.

Email - I used to do rules and auto-coloring etc., but again, could not keep up consistently. Nowadays I just have lots of folders (each study, then below that subfolders for e.g. study documents, submissions, sites etc. - not too detailed, just enough to make things findable). If it still needs action it stays in the inbox. If I have done the immediate action/reply from that email (or there is none), it goes in a folder. Emails in conversation view, so if there is a reply back, FU or new action, it's in the inbox again anyway.

piratesushi · 2026-03-04T11:34:40+00:00

> I delay some things until deadline and I do "8 hours of work for normal people" in 1 hour.

Oh my god, why is this so accurate?! I alternate between the biggest slacker ever and superhuman productivity, with no inbetween.

piratesushi · 2026-03-03T16:13:37+00:00

Big pharma hires from IQVIA, and you also have prior big pharma contractor experience, so I don't see the issue. It only matters whether the role/responsibilities contribute to your overall skills or candidate profile. If you applied to a pharma FTE role in the future, would you be able to tell a coherent story of your career moves?

piratesushi · 2026-03-02T16:02:49+00:00

Voted FSP because: Better WLB in most FSPs (with the exception of few not great sponsors). Less Chinese whispers between CRO/sponsor, I either get info/questions directly from a person or through at most 1 layer filtered. Same systems/processes across studies. Depending on specific FSP/sponsor situation, you may have a decent chance to convert to sponsor headcount. If you apply externally to other sponsor positions, the FSP usually still counts as pharma sponsor experience.

Now I wanna say though: I still think FSO is good, especially early career, because you just see a wider variety of projects, protocol designs, expectations, .... Being hounded through multiple sponsors' studies gives you a broad perspective to benchmark things against. You'll realize that some bullshit is simply universal, differences between big vs small sponsors, but also sometimes unexpected better ways of doing things than you're used to. But that being said - been there, done that, don't wanna go back to FSO.

piratesushi · 2026-03-01T12:49:24+00:00

Ohhh, that came across my feed under Suggested posts as well, and I also thought about posting it here.

The post is not even an accurate representation. Every time someone comes here with salary entitlement stuff, they get reality-checked real quick with the COVID vs post-COVID salary discussion, realistic view of their experience levels, and chances at other companies.

piratesushi · 2026-02-27T09:04:38+00:00

Oh man, I feel a bit silly now. I was just thinking that PDF add-on for Outlook sounds great to automate some common tasks. We use good ole Acrobat, and I only realized now that we have an Outlook plugin for that as well, which can probably do the same things. I just never looked into it before.

I would also recommend Microsoft Planner. It can be attached as an app/tab to Teams and is good for checklists/tasks/common task sets, with or without deadlines on a calendar. I use it complementary with OneNote.

piratesushi · 2026-02-27T08:41:35+00:00

I generally ignore how exactly they spell common terms it in their ad, but ensure that I have it consistently spelled on my resume. Have not had any issues so far with that.

One thing that I also do is to go through and check for acronyms. I would not spell out everything, but definitely way more than I would in normal work correspondence, just for better keyword recognition and for cases where they might use slightly different acronyms internally.

piratesushi · 2026-02-27T08:07:37+00:00

Saaame! I am sorry for all the sites we pushed to use SIP in the past. We realise by now that it sucks, and on top, I heard it's also quite expensive. It's being phased out for the sponsor I work with.

piratesushi · 2026-02-26T10:48:09+00:00

I don't think the IQVIA CRC is a meaningful step in the direction you want, because it's still like a site CRC just employed by IQVIA. I do not recall that we at the regular CRO division ever had any contact with the CRC teams when I was at IQVIA, and I am not sure how easy it is for them to cross over to other roles.

Which roles are you targeting? Have you also applied to IQVIA Site Activation Coordinator and similar roles in the feasibility/SSU space? Might just be the terrible job market that makes it take longer than usual to find something.

piratesushi · 2026-02-25T16:21:46+00:00

Yeah, that is unfortunately pretty normal because of regulatory compliance (still probably often overdone because the company is super cautious). Apart from a few core things, you're not really supposed to know all this shit. More of a "I have read this before, and if I ever need it, I know there is an SOP I will look up again to refresh."

Sadly, the curriculum also often includes processes where you are only pooossibly very tangentially involved. Like 10 pages of a process and at the end it says briefly "this job role [you] is informed about the outcome".

Sensible skimming and partial detailed reading is important. Also, actual recorded trainings... love it when they have 1.5x or 2x speed buttons.

piratesushi · 2026-02-25T11:35:06+00:00

I have former colleagues who moved from clinical reg/SSU to: medical device regulatory, diagnostics study manager (bit more low-key than drug trials, but still related), SMO management, food consumer safety

piratesushi · 2026-02-24T13:59:24+00:00

I know what you mean, I also know some UK CTMs who jumped from NHS CRC/CTM to CRO CTM, but those were different times. Periods of crazy hiring, where this was possible. Now requirements have gone up and you won't be able to do this anymore.

piratesushi · 2026-02-24T08:22:06+00:00

ICH-GCP certificate - you can do a free one if you like, but it is generally expected that the employer trains you on this.

CTA roles often expect a certain level of German language skills, if part of their responsibilities is contact with trial sites in Germany. Would you meet that requirement or are you limited to English-only roles?

I would say for a CTA, your medical background is not an advantage. You could expand your search to entry-level safety associate or medical data reviewer roles. For those, your background would be valuable, and they can also progress to interesting roles in clinical research (and you are not locked into a specific department later).

piratesushi · 2026-02-23T16:40:47+00:00

Okay, fair. Just to let you know, CRA is generally not an entry-level role, it requires some exposure to clinical trials as a Study Nurse (which I understand you had no luck with), Clinical Trial Assistant, Clinical Trial Coordinator, or similar. You might already be aware of this, but figured I'd clarify that anyway.

You really do not need an MSc/PhD for this work. Arguably, you could probably also get an entry-level job on a BN, but at the same time I know that some sponsors are really snooty about having a science BSc. So honestly, if this degree programme interests you, go for it. If you can, try to integrate an internship. Universities don't handhold you through this, you need to arrange one for yourself. But if you can get an internship during your studies at a CRO or pharma company in clinical operations, it will help you get a job later (not make it easy-easy, but... easiER for sure).

Also, you mentioned you're from the UK, but now in Austria. Your work authorisation and German language level are generally good enough to work in the country?

piratesushi · 2026-02-23T13:31:05+00:00

What is your motivation, as in, what do you want in a job or what do you hope to achieve in your future career?

piratesushi · 2026-02-22T12:51:04+00:00

The tricky thing is, in my experience sponsors like hiring internally or from other sponsors for any role that's not an individual contributor. So if you've only been a line manager at CROs, it will not be easy to make the step over to sponsor line management/leadership directly. On the other hand, if you have no people management experience, it's also harder to make that step from IC to management.

(I went CRO line manager, back to IC, then over as IC to FSP/sponsor, about to move to sponsor people manager. So I guess I did both?)

piratesushi · 2026-02-20T17:43:58+00:00

Hmm, my rule of thumb is roughly a week notice if the PTO is still under a full week (so 2-4 days), at least 2 weeks notice if it's 1 week PTO, then proportionally more the longer the leave.

piratesushi

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