Clinical Trial Operations Manager

THRYVE; Berlin; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A digital cardiology company in Berlin is seeking a Clinical Trial Operations Manager to oversee the entire operational execution of a pivotal FDA clearance trial. This role offers full ownership, allowing you to manage CRO performance, budgets, and timelines while working closely with top-tier institutions. The ideal candidate will have experience in running trials, managing sites, and strong knowledge of regulatory environments. You will have a visible impact on the success of the trial, making this a unique opportunity for someone looking for real ownership in their work.

Qualifikationen

• Experience in running pivotal clinical trials.
• Ability to manage multiple sites and CROs effectively.
• Strong knowledge of FDA and regulatory environments.

Aufgaben

• Oversee day-to-day operations of the FDA trial.
• Manage CRO performance, timelines, and budgets.
• Ensure audit-readiness and quality of the study.

Kenntnisse

Running clinical trials

Managing CROs

Understanding of GCP

Experience with medical devices

Problem-solving

Jobbeschreibung

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