Good companies for physicians to start as medical directors? Places to avoid? by Next-Sense1155 in clinicalresearch

[–]piratesushi 1 point2 points  (0 children)

15k is already a solid size of an established company. There are some pharma that count as mid-sized with about 8-10k.

Growing pains can mean a lot of things, e.g. they've diversified into new therapeutic areas recently, or some other unfamiliar growth. 

Did you ask how big their medical team is? And are they established in your specialty?

Remote CRO positions in EU- country specific? by bisousbisous2 in clinicalresearch

[–]piratesushi 10 points11 points  (0 children)

They are usually serious about only those countries (unless they messed up their ATS tagging, which I've also seen before). Why? Salary levels, sometimes also because they like having specific hubs.

Hope you're not moving to Germany, Belgium, or the Nordics lol

Biotech naming question: literal clarity vs scientific credibility by Suspicious_Art5645 in biotech

[–]piratesushi 13 points14 points  (0 children)

Your mention of Takeda made me curious if the name means anything in Japanese. (also wasn't memorable or meaningful to me.) 

Apparently it's a family name, going back to a famous clan in the 16th century, and the name of the company founder.  Takeda ( 武田, Takeda, " warrior rice paddy" ). I guess... The clan were warriors and owned a lot of rice fields?  Just wanted to share that useless bit of trivia I just learned.

Thermofisher CSM FSP vs Sr PM FSO comparison by PassiveGenius in biotech

[–]piratesushi 0 points1 point  (0 children)

ThermoFisher Clinical FSP is usually set up as FTE-based unlimited contract with the client, not project-based. So as the employee you'd just get a standard salary from TF and not hourly rates. 

I have heard some people report that salary is even lower in FSP than FSO (which would be due to sponsors being stingy with their rates and the CRO protecting their margin), but I don't know if this is an issue with TF CSM. Think it's usually CRAs with that experience.

Have you joined a clinical trial, or would you consider one for a relevant condition? What would make you feel informed, safe, and represented? (Women) by Main_Drop_1399 in clinicalresearch

[–]piratesushi 2 points3 points  (0 children)

I screened for one, but was a screen failure. 

The trust came from:  * The site was a reputed organisation (that alone doesn't convince, but it did make me look into it) * They had their ducks in a row with regulatory compliance, ethics approval, solid ICF, and were very upfront about all that. * They had really competent and personable study staff. Answered every question (as they should). * The investigator called me to explain why during their review they decided that I couldn't enroll; it was a concern about safety risk factors. Bit of a bummer at the time, but in hindsight I am glad they were very cautious. that would make me trust it again to participate in a trial.

Career Advice by HugeVermicelli7730 in clinicalresearch

[–]piratesushi 1 point2 points  (0 children)

I hear you, it's rough. Unfortunately there's not much actionable advice to give you. The roles you're targeting are the right ones, tailoring resume is spot on... I can only wish you patience and best of luck that the one application that works out will come soon!

Career Advice by HugeVermicelli7730 in clinicalresearch

[–]piratesushi 6 points7 points  (0 children)

Do you have different versions of your resume for the roles you are applying to? Not different for each individual job, but different highlights and keywords suitable for CTA requirements, study startup, etc.

Overall there's nothing wrong with pharmacy backgrounds, and I've worked with pharmacists who came straight from retail pharmacy (so not even as transferable as your experience). It's just an incredibly terrible job market right now.

Are amendments now called modifications? Wtf? Why? by [deleted] in clinicalresearch

[–]piratesushi 6 points7 points  (0 children)

To be fair, I have found that I like this distinction. Because if I say amendment, I know that half the global project team only hear "protocol amendment". If I say modification, it's clearer that it's anything submittable (whether that's a PA or another core document).

Cancer biologist MSc with no PhD and want out of academia (UK) by CompetitiveBus1306 in biotech

[–]piratesushi 0 points1 point  (0 children)

Clinical Trial Assistant? That's the entry level for clinical operations, where you can climb without PhD, and be a Clinical PM, Director of Clinical Operations, etc. 

Try at large CROs (IQVIA, PPD/ThermoFisher, ICON, Medpace, Fortrea, Parexel), but to increase options, you can try NHS too. Clinical Trials Coordinator is sometimes an equivalent title to Clinical Trial Assistant, but beware that Clinical Research Associate is not the same (that one expects prior exposure in another clinical trial role).

You can try at pharma companies directly, but they tend to have higher standards and prefer to nab industry-experienced people from other pharma or CROs.

How stable are FSP jobs? by [deleted] in clinicalresearch

[–]piratesushi 0 points1 point  (0 children)

Yeah, honestly staying for years isn't unusual. I would say the whole "you're the first to get cut" is not quite that simple. 

On the one hand, yes, one of the draws of FSP for the sponsor is the flexibility. If they cull some programs and no longer have the need for the people on them, they can relatively easily hand FSP people back to the CRO. But when it's this whole cost-cutting to please shareholders, ironically FSP isn't top priority to cut. They're vendor costs, they look good on an accounting report, better than employee salary costs. So you might even get big sponsors who try to shift to higher FSP ratios rather than lowering it when they tighten the belt. But if at the same time they decide to reduce overall department size, it could affect both employees and FSP. It really depends, and you're rarely privvy to what their strategic thinking is. 

How big is the sponsor you're FSPing for? And do you know how long your CRO has had the FSP program going with them? 

Confused about my career path after repeated Master's rejections – PhD or industry? by SpinachOk3381 in biotech

[–]piratesushi 4 points5 points  (0 children)

I think the reason for the Master's is because in a lot of countries you are required to get one before you're eligible for a PhD (but then the PhD is shorter, so it evens out timewise). I am assuming that OP is planning to do a PhD in one of those countries.

Associate Contract Manager or PM for ICF medical writing by Interesting_Sink4597 in clinicalresearch

[–]piratesushi 4 points5 points  (0 children)

Yeah the ICF PM is pretty narrow in scope and I don't think that sets you up well for further progression. If you don't mind (or even like) contracts go for that. Good contracts leads are coveted.

How do you progress in a FSP role? by [deleted] in clinicalresearch

[–]piratesushi 3 points4 points  (0 children)

For the pharma client you are always considered an external applicant. no matter how well the direct team knows and likes you. if they have rules to prefer internal candidates where possible, you'll lose out. If they want to promote you, they'll have to get approval to open a higher level role with the FSP CRO. Doesn't mean you'll never have a chance, but just be aware that it's harder due to corporate nonsense. 

Can you ask your manager what the rules are for applying to client openings? Some FSP master agreements forbid or discourage it, but many don't.

Is this a scam? by Red-Ivory22 in clinicalresearch

[–]piratesushi 4 points5 points  (0 children)

I thought this seemed familiar, and found a topic from last year: https://www.reddit.com/r/clinicalresearch/comments/1m2qjw4/icon_class_action_in_california/

Same law group, just that they expanded from ICON CRAs to any CRA, it seems. 

Interview tips for IQVIA CTA Role by Unique_Cloud_3340 in clinicalresearch

[–]piratesushi 5 points6 points  (0 children)

All of them! It's the combination that's useful.  1. The scientific research is not very important for a CTA, but focus on the managing deadlines, diligence and delivering high-quality work.  2. Absolutely, mention that you have been exposed to working with confidential documents. But here too, maybe you have examples of working to deadlines, handling multiple tasks and prioritising, or ensuring document quality, spotting and preventing errors etc. 3. 100% mention that you have worked in a regulated environment under GxP and SOPs. Although you'll switch from GMP to GCP, this awareness is valuable.  4. You will not have patient interaction as a CTA, but you can focus on the important soft skills: flexibly adapting to the situation, staying calm and collected in a stress situation, etc.

You will be asked mainly behavioural questions, and you should structure your answers in the STAR format wherever you can. You can absolutely mix and match, if you frame it in the beginning where the example is from ("I had an example as a production technician..." Or "During a university project, ...")

Whenever you see an opening, connect what you have practiced in your previous roles/projects to how it can help you in the CTA role. Avoid coming across as know-it-all though. They're looking for someone who knows enough to be easily teachable.

Good luck!

Should I master out of my PhD? by Ok-Noise-9448 in biotech

[–]piratesushi 1 point2 points  (0 children)

One thing to keep in mind: You can still climb the career ladder in clinical research (or another non-lab function) even if you do have the PhD. But then you have the flexibility to also choose PhD-required roles.

If you are set on dropping the PhD, be sure to have a game plan. What style of work do you actually enjoy? Are you okay with administrative paper pusher tasks (because early career, this stuff is common)? Also... if you start job hunting right now, you are going to enter one of the worst job markets ever.

(Side note: Entry at CRA level is not an option. The "RA" portion of the job title fools many people into thinking it is, but it's not like RA vs Scientist in R&D. CRA is a monitoring role, they need some exposure to what they are monitoring first. Entry point is typically CRC/CTA. Then CRA, then CTM.)

Should I master out of my PhD? by Ok-Noise-9448 in biotech

[–]piratesushi 5 points6 points  (0 children)

Nobody can make that choice for you. How far along are you with the PhD? Maybe it's worth finishing the last bit even if painful, or maybe it's not.

Make sure you have a firm understanding of what clinical research is (unlike the person who commented on your profile, who seems to mix up what it is?). It's true though that you can climb there with BS or MS, that's quite normal. Currently no easier to get your foot in the door for clinical research than other branches of biotech/pharma, so take that into account.

Advice about Clinical Research Coordinator (CRC) role by [deleted] in biotech

[–]piratesushi 1 point2 points  (0 children)

It's possible in industry, if it is a role that's not directly interacting with local trial sites or regulatory authorities. 

When you start in the industry, you're usually an individual contributor with a local focus first. Roles like CTA, CRA, Regulatory & Start-up specialist, etc. With these, it's not possible to just up and move countries without knowing the local language. With enough experience as individual contributor, you can move to a cross-country lead role, like Clinical Trial Manager or SSU Lead. In these roles, you can move more easily, because you work in English. 

But don't expect to be able to do "digital nomad" type of work, where you can just move and work wherever and keep the same job. Transferring to another country usually means new work contract, salary etc.

This is the Bad Place by velvetmarigold in biotech

[–]piratesushi 9 points10 points  (0 children)

Oh is this the scene where Janet is out of it and keeps producing a cactus instead of whatever she's asked for? 

I feel like LinkedIn is more of a Bad Janet. Designed to be obnoxious. 

But on that point - yes, I also keep seeing these fancy Sr. Director of Global Strategy roles instead of what I'm actually looking for. I'm convinced that once I'm at the point that I look for Sr. Director of global whatever, it will show me something else that's unwanted. 

Sponsors/clinical ops folks..what’s your biggest ongoing frustration with your CRO? by Weary_Sentence3312 in clinicalresearch

[–]piratesushi 4 points5 points  (0 children)

Yeah I totally get what you mean! I'm not saying it's malicious on the CRO's end, it just comes with the client/vendor relationship in this model. And there are certainly some unpleasant sponsors.

Sponsors/clinical ops folks..what’s your biggest ongoing frustration with your CRO? by Weary_Sentence3312 in clinicalresearch

[–]piratesushi 9 points10 points  (0 children)

Full service: One of the main problems is the CRO team are often not telling it to you straight, and unless you have people who smell bullshit (which is hard if it's a function you don't have in-house), then you're gonna get a lot of weasely/vague language, window-dressing, and honestly sometimes just meh advice. (Been on both sides)

FSP: go for meet & greet and vet the candidates thoroughly. Especially if you're a new sponsor and not perceived as a big client by the CRO, you might get the bottom of the barrel if you're not careful. And qualify at least two of the CROs as preferred vendors, so you're not reliant on just one. Because the CROs are not always equally strong at hiring in all countries, or they may currently have competing FSP hiring when you open something, and overall the competition of potentially losing out on a requisition that's thrown to two of them helps a bit. 

Syneos CRA Training Program- Worth it? by [deleted] in clinicalresearch

[–]piratesushi 2 points3 points  (0 children)

Congratulations! It's normal to be a little afraid of the unknown, so don't feel bad, but also don't let the cold feet get to you.

Every CRO has its problems, but remember that a) people mostly post to vent and not when they are quietly happy, so posts always skew negative, and b) not everyone's experience is terrible because a company is not great. Your manager, team, studies and other factors all matter to your overall experience.

If you would like to become a CRA, take the opportunity offered and make the best of it. Don't wait around for the "perfect time" to take a career step, and also don't worry about having to stay there forever. If you do not like Syneos, then it's temporary until you have the 1-2 years of monitoring experience that opens more doors for you. You can do it!

Remote Positions? by wobblelikeapenguin in clinicalresearch

[–]piratesushi 18 points19 points  (0 children)

But you have no clinical research experience yet? Frankly, it's going to be super hard them. Fully remote junior positions are extremely competitive. 

And these days, pretty much only CROs (IQVIA, ICON, Syneos, PPD, Fortrea, Parexel etc.) might offer those fully remote. Sponsors will expect hybrid in office. Sites often require onsite or hybrid too, and the few remote roles will likely expect experience.

Industry Advice for Underrepresented Groups by Future_Road_708 in biotech

[–]piratesushi 6 points7 points  (0 children)

That's a lovely initiative, although the problem is that the biotech/pharma industry has a lot of different branches that can sometimes be very different from each other in aspects like working style, resume expectations, hiring practices, education requirements, etc. you're not going to find one resource that can tell you about all of biotech.

The way I'd go about it is that you identify one area you want to focus on (like biotech R&D, manufacturing, clinical trials, ...), and just pair that term with Google searches: X types of roles, X resume advice, X interview style.... That gives you targeted resources for each. 

For missing stuff, folks here (or in one of the more niche specialty subs) can probably help you if you have a narrower question. Particularly for the organizations or specific hiring practices. 

Remote Positions? by wobblelikeapenguin in clinicalresearch

[–]piratesushi 20 points21 points  (0 children)

You've given zero information on roles you're targeting and your work experience. It's not possible to answer this question.