Senior Clinical Trial Manager

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

Zusammenfassung

A Berlin-based digital cardiology company is seeking a Clinical Trial Operations Manager to own the full execution of a pivotal FDA trial. This role involves managing the entire trial process, ensuring sites are activated, patients recruited, and data maintained to high standards. Ideal candidates will have prior trial management experience and a solid understanding of regulatory environments. This unique position offers significant responsibility and the opportunity to collaborate with top-tier institutions.

Qualifikationen

• Proven experience in running FDA clinical trials, not just supporting them.
• Experience managing sites and global studies.
• Strong background in medical devices, digital health, or diagnostics.

Aufgaben

• Run day-to-day operations of a pivotal FDA trial.
• Own CRO performance, timelines, budgets, and quality.
• Activate and train sites, and recruit patients.

Kenntnisse

Running clinical trials

Managing CROs

Understanding GCP and regulatory environments

Ownership and 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