Clinical Trial Manager

Valeriot FlexCo; Wien; Hybrid; EUR 46.000 - 55.000; Vollzeit

Benefits dieser Stelle

Office in Vienna

Hybrid work model

Zusammenfassung

Valeriot FlexCo, a Vienna-based medical device start-up developing AutoVein, seeks a hands-on Clinical Trial Manager to lead international clinical investigations (EU MDR, FDA CFR, ISO 14155). You will manage submission preparation, site activation, monitoring, data management, and close-out across Europe and the US.

You will shape trial design, coordinate with surgeons and investigators, oversee TMF/eTMF and CROs, and ensure sponsor oversight.

Qualifikationen

• Hands-on clinical operations experience with medical device investigations.
• Knowledge of ISO 14155, EU MDR, FDA/IDE requirements.
• Experience coordinating regulatory submissions and site initiation.

Aufgaben

• Translate the clinical plan into practical operational plans for submissions and site activation.
• Coordinate regulatory submissions with ethics committees and authorities.
• Oversee submission workflows, questions, amendments and approvals.
• Decide what activities to perform in-house vs. outsource to CROs/CRAs.
• Own the EDC/eCRF workflow including design, testing and data reconciliation.
• Maintain TMF/eTMF readiness and inspection-ready study records.
• Prepare sites for activation and conduct initiation, monitoring, and close-out visits.
• Ensure sponsor oversight and alignment with QA/RA requirements.
• Travel to investigational sites in Europe and the US as needed.

Kenntnisse

Clinical Research

Regulatory Compliance

Project Management

Trial Design

Data Management

Jobbeschreibung

We are looking for a highly motivated individual who knows what it takes to move an international medical device study from submission preparation through execution and close-out.

About us
We are a Vienna-based medical device start-up developing AutoVein - a novel vein-harvesting system for coronary artery bypass grafting, the most common cardiac surgery worldwide.

Our goal is ambitious: to improve the standard of care in bypass surgery by making high-quality vein harvesting less invasive, more reproducible, and more accessible. The work is technically demanding, but the impact is very real: better tools for cardiac surgeons, better graft quality, and ultimately better outcomes for patients undergoing one of the most important procedures in cardiovascular medicine.

Valeriot is run by engineers and built around technical depth. We combine strong in-house engineering with excellence in regulatory affairs, quality management, clinical affairs, and surgical expertise. Two cardiac surgeons are part of the team, and clinical, regulatory, engineering, and manufacturing questions are not treated as separate worlds - they are developed together.

We are now moving from proof of concept toward a regulatory-ready system. With the MINERVA clinical investigation entering submission preparation in Europe and the US, we are strengthening our in-house clinical operations capability - not only to execute MINERVA, but to build the systems, expertise, and operational foundation for a broader clinical program that will include future studies beyond MINERVA.

Clinical Trial Manager - Medical Devices

Medical Device | Clinical Operations | EU MDR | FDA CFR | ISO 14155

The role

As Clinical Trial Manager, your immediate priority will be the operational delivery of MINERVA, our international clinical investigation of AutoVein. You will join as we prepare regulatory and ethics submissions and will establish the plans, systems, oversight, and working relationships needed to conduct the investigation reliably across Europe and the US.

As Valeriot's clinical program evolves, you will help shape the design and execution of subsequent investigations. These may include randomized comparative trials against established systems, as well as clinical studies exploring additional indications and future product generations.

This is a hands‑on sponsor-side role, but not an isolated one. You will work as a peer to our highly experienced CMO and QM/RA Manager, giving MINERVA a strong in‑house core across medical leadership, clinical operations, regulatory affairs, and quality management. The QM/RA Manager will lead the broader regulatory framework, while you will own the clinical‑operational execution and prepare and coordinate the clinical components of submissions. You will also collaborate directly with the CEO, cardiac surgeons, study investigators, clinical sites, and external specialists.

The participating sites will have already been contracted. Your mandate begins with submission preparation and continues through initiation, enrollment, monitoring, data cleaning, database lock, and study close‑out.

You will help decide which activities Valeriot should retain in-house and which should be assigned to CROs, CRAs, data‑management providers, or other specialists. In the US, you will help establish and manage an appropriate local clinical research support arrangement while retaining effective sponsor oversight.

What you will work on

• Translate the Clinical Investigation Plan into a practical operational plan covering submissions, site activation, monitoring, data management, timelines, risks, and study milestones
• Prepare and coordinate the clinical components of competent authority, ethics committee, FDA, and IRB submissions in close collaboration with the QM/RA Manager
• Manage submission workflows, authority and ethics committee questions, amendments, notifications, approvals, and the clinical documentation supporting them
• Define which clinical activities should remain in-house and which should be outsourced, and select and oversee the corresponding CROs, CRAs, consultants, and specialist vendors
• Own the clinical requirements for the EDC and eCRF, including CRF design, completion guidelines, user‑acceptance testing, edit checks, data review, query resolution, reconciliation, and database‑lock readiness
• Establish and maintain a complete, current, and inspection‑ready TMF/eTMF, with clear oversight of essential documents held at the investigational sites
• Prepare sites for activation and conduct or oversee site‑initiation visits, investigator and site‑team training, interim monitoring, remote monitoring, and close‑out visits
• Oversee the US clinical research support model and ensure that locally performed activities meet Valeriot's study, quality, and reporting requirements
• Track enrollment, protocol deviations, informed consent compliance, device accountability, safety information, data quality, and other signals requiring sponsor action or escalation
• Coordinate study close‑out, final document reconciliation, database lock, archival readiness, and the operational inputs required for analysis and the Clinical Investigation Report

What you bring

• Demonstrated hands‑on clinical operations experience with medical device investigations, covering submission preparation, study start‑up, conduct, monitoring, and close‑out
• Practical knowledge of Good Clinical Practice for medical device investigations (ISO 14155), EU MDR clinical investigation framework, and relevant US FDA and IDE requirements
• Experience preparing or coordinating regulatory and ethics submissions and responding to questions from authorities, ethics committees, or IRBs
• The ability to prepare for and conduct site initiation, interim monitoring, remote monitoring, and close‑out visits
• Strong experience with EDC and eCRF workflows, including CRF design, UAT, data review, query management, reconciliation, and database‑lock preparation
• Experience establishing, maintaining, or quality checking a TMF/eTMF and keeping study records inspection ready throughout the investigation
• Sound judgment in deciding what to perform internally and what to outsource, combined with effective oversight of CROs, CRAs, sites, consultants, and data‑management providers
• Clear written and verbal communication in English, including the ability to work effectively with surgeons, clinical‑site teams, regulators, technical colleagues, and external partners
• A relevant academic or professional background in clinical research, life sciences, medicine, nursing, biomedical engineering, or a related field
• Willingness to travel to investigational sites in Europe and, where needed, the US

What we offer

• The chance to contribute to work that can ultimately be felt by patients in operating rooms around the world
• A technically serious medical device start‑up run by engineers, with strong clinical, regulatory, quality, and manufacturing expertise around the table
• Close collaboration with cardiac surgeons, relevant external specialists, and the founding team
• Real responsibility without being isolated: you will own important questions while working inside a capable team
• A hands‑on culture with short decision paths, high standards, and no corporate overhead
• An office in Vienna's 13th district, very close to U4 Hietzing
• A central role in building Valeriot's in‑house clinical operations capability and starting with MINERVA and extending into future clinical programs
• Direct involvement in an international medical device investigation spanning Europe and the US

Salary

The actual minimum salary is 4,500 EUR gross per month (on a 40-hour basis), the actual salary depends on your qualifications and experience. The salary is paid 14 times per year.

Overtime

Any accrued overtime is compensated in the form of time off.

About this job

Employment type: Full Time (Permanent employment)

Salary: from 4,500 EUR monthly

Seniority level: Professional Experience, Project or Team Lead, Senior Position

Work model: Hybrid

Place of work: Wien 13. Bezirk (Hietzing)

Field of work: Pharmaceutical, Health, Social, Science, Research

Unfilled vacancies: 1 vacancy unfilled for this position

About the company

Employer: Valeriot FlexCo

Number of employees: 1 - 10 employees

Locations: Wien

Details about this job

Full Time (Permanent employment)

• Monday to Friday
• 40 hours
• Willingness to travel

Place of work

• Wien 13. Bezirk (Hietzing)

Must-have skills

• Clinical Research
• Regulatory Compliance
• Project Management
• Trial Design
• Data Management

Required languages

• English C2

All infos regarding your application

Required application documents:

• Résumé
• Cover letter