Clinical Trial Operations Manager

Clinical Trial Operations Manager (FDA / Digital Health) aka Clinical Project Manager / Clinical Study Manager

Run the FDA trial — not just a piece of it.

Most clinical trial roles give you a slice: a region, a function, a vendor. This one doesn’t.

A Berlin-based digital cardiology company is preparing a multi-center FDA clearance trial for a novel heart failure monitoring technology — and they’re hiring someone to own the operational execution end-to-end.

You’ll be the person who actually makes the trial work: sites live, patients enrolled, data clean, timelines hit.

Why this role is different

• Full ownership: not a region, not a function — the entire trial execution
• Direct line to decision-making: work closely with leadership, not layers of management
• Real scale: multi-site, international, FDA-facing study
• Top-tier collaborators: work with institutions like Charité, Mayo Clinic, UCSF
• Less process, more progress: no corporate overhead slowing you down
• Visible impact: your work directly determines trial success and regulatory outcomes

What you’ll actually be doing

• Running the day-to-day operations of a pivotal FDA trial
• Owning CRO performance, timelines, budgets, and quality
• Getting sites activated, trained, and recruiting
• Solving problems in real time — not escalating them through layers
• Keeping studies audit-ready and on track
• Working directly with clinicians, product, and data teams to keep everything aligned

What they’re looking for

• Someone who has already run trials , not just supported them
• Experience managing CROs, sites, and global studies
• Strong understanding of GCP and regulatory environments (FDA / ISO / MDR)
• Background in medical devices, digital health, or diagnostics
• A doer — someone who takes ownership and drives things forward

Why people leave for roles like this

• You’re tired of owning only a fraction of a trial
• Decisions take weeks instead of hours
• You’re far from the actual impact of your work
• You want to step up into real ownership , not wait years for it