Vakula Connect is our regular update for consultants deciding where to take their next assignment and for clients planning their next programme. This edition covers Q1 2025.
Market signals
- ICH adopted E6(R3) in January; FDA issued draft guidance on AI in regulatory decision-making; and on 31 March a federal court vacated the LDT rule.
- Sponsors began rewriting monitoring plans and vendor oversight procedures to E6(R3); CRAs with centralised monitoring experience were in demand.
- Data and analytics roles with regulated-environment experience commanded a premium.
Roles in demand this quarter
Titles that recurred in client requisitions: Senior CRA, Clinical Quality Assurance Auditor, Data Scientist (pharma), Regulatory Writer. Current openings are always on our careers page.
Signal to leaders
The disciplines that were hardest to fill were the ones where clients needed judgement as well as capacity; briefing for the judgement shortened time-to-fill.
At Vakula
We published guidance for clients on what to keep from LDT preparation, and our clinical consultants supported E6(R3) SOP rewrites.
For consultants
Rate, duration, location and client are disclosed before you decide to interview; you get feedback after every submission; there are no fees to candidates at any stage. Send your resume.
For clients
Send one requisition and judge the shortlist. Start here.
Join the conversation
Tell us what you are working through at info@vakulatech.com; we may feature the question in a future edition.