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Manager, ClinOps (OrphaCare)

AOP Orphan Pharmaceuticals GmbH -
Wien, W

Jetzt bewerben

Details zur Stelle

Vollzeit

Qualifikationen

Master
Bachelor

Vollständige Stellenbeschreibung

Full-time Vienna

We are looking for a Manager, ClinOps at OrphaCare to drive the successful planning, execution, and oversight of clinical investigations for innovative Class III medical devices. In this role, you will act as the operational lead across all clinical trial activities—from study start-up to close-out—ensuring high-quality, compliant, and timely delivery in line with regulatory requirements and company standards. You will work cross-functionally and with external partners to translate clinical strategy into operational excellence.

What Your Day To Day Will Look Like

Lead end-to-end operational planning, execution, and oversight of clinical investigations
Translate clinical investigation plans into detailed operational strategies, timelines, and deliverables
Manage study start-up, site selection, feasibility, and activation activities
Oversee site management, study logistics, and documentation (including eTMF readiness)
Act as primary operational contact for investigative sites and ensure effective communication and training
Ensure studies are conducted in accordance with ISO 14155, EU MDR, ICH-GCP, and internal SOPs
Drive vendor and CRO selection, contracting, onboarding, and performance management
Monitor vendor deliverables, KPIs, budgets, and timelines in collaboration with internal stakeholders
Coordinate cross-functional teams (e.g., Clinical, RA, QA, Data, Statistics, Safety, R&D)
Ensure inspection readiness and support audits and regulatory inspections
Identify and escalate risks related to quality, timelines, or compliance
Maintain study trackers, documentation, and operational reporting

Your Qualifications And Experience

Minimum 5 years of experience in clinical operations or clinical project management
Proven experience in managing clinical studies, including vendor oversight and cross-functional coordination
Strong experience in medical device clinical investigations (Class III/high-risk devices preferred)
Solid knowledge of ISO 14155, EU MDR 2017/745, and ICH-GCP/GxP standards
Experience with CRO/vendor management and inspection readiness
Bachelor’s or Master’s degree in Life Sciences, Biomedical Engineering, Medicine, or a related field
Fluency in English (written and spoken); additional languages are an advantage
Strong organizational skills, attention to detail, and ability to manage complex projects
Excellent communication skills and ability to work effectively in a matrix environment

Our offer

An open corporate culture with the opportunity to contribute your own ideas
Working independently in a collegial and committed team
Modern working environment with good public transport connections (U4 - Heiligenstadt)
Flexible working hours (flexitime/time-out days), bonus scheme, additional benefits and employee events
Structured onboarding and support through a buddy system
Due to legal requirements, we are obliged to disclose the collective agreement minimum salary, which is EUR 45.080,- gross per year, based on full-time employment. However, our actual remuneration packages are market-oriented and aligned with your qualifications and professional experience.

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Please submit your application exclusively via the application link.

Introduction

Main Benefits

Bonus

Homeoffice

Employee mobile phone

Flexible working hours

Laptop

Initial and continuing education

Canteen

Good transport connection

Employee events

Meal allowance

Company doctor

Parking spot

Healthmeasures

Employee discount

Your Contact

Kenny Trappl

Talent Acquisition Manager

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Erweiterte Suche

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