Senior Clinical Research Associate (CRA II) (m/f/d)

Vivalyx GmbH; Köln; Hybrid; EUR 65,000 - 95,000; Full time

Benefits offered by this job

Company car

Public transport ticket (Deutschlandt

Urban Sports Club membership

Flexible, mobile working arrangements

Regular opportunities or training and

Employee stock option program

Job summary

Vivalyx GmbH, a Cologne-based medical technology startup, is seeking a Senior Clinical Research Associate to lead site management and monitoring across multiple clinical studies. The role covers on-site and remote monitoring, TMF maintenance, and risk management, with studies in Europe and the United States.

You will build strong relationships with investigators and coordinates, travel regularly, and ensure compliance with GCP and ISO 14155.

Qualifications

• 2+ years of CRA experience preferred, including direct on-site monitoring.
• Experience with medical-device clinical investigations is preferred.
• GCP and ISO 14155 experience required.
• Working knowledge of ICH-GCP required.
• Ability to manage multiple studies and priorities independently in a fast-moving startup environment.
• Clear, pragmatic communicator who can work confidently with investigators, coordinators, CROs, and internal stakeholders.
• Willing and able to travel regularly within Europe and to the United States.
• Fluent in English, both written and spoken (German is a strong plus).

Responsibilities

• Act as Vivalyx’s primary operational contact for investigators and study coordinators.
• Prepare, conduct, and document site initiation, interim on-site and remote monitoring, and closeout visits.
• Perform source data review and verification.
• Track study progress enrollment, follow-up visits, data-entry status, queries, protocol deviations and training needs.
• Review and follow up adverse events, adverse device effects, and device deficiencies.
• Maintain the TMF and support database-lock, audit and inspection readiness.
• Proactively identify risks, resolve operational issues, and escalation when needed.
• Collaborate with cross-functional teams, sites, and CROs to ensure successful study delivery across multiple parallel studies.

Skills

CRA experience

GCP/ICH-GCP

English proficiency

German language

Travel readiness

Job description

Join Us in Saving Lives of People with Organ Failure

At Vivalyx, a medical technology startup based in Cologne, we're on a mission to save the lives of those suffering from organ failure. Our innovative approach aims to dramatically improve the vitality and availability of donor organs. As we gear up for certification and related studies, we're seeking dedicated team members (m/f/d), permanent or contractor, to join us starting as soon as possible, for 32-40 hours per week.

We provide the opportunity to work on groundbreaking technology that has a meaningful impact. You'll be part of a dynamic, highly skilled, and motivated team. We prioritize flexibility, offering mobile working conditions and a flat hierarchical structure. In addition, we support professional development and career growth, along with an attractive employee participation program.

Your role

We are looking for a passionate and experienced Senior Clinical Research Associate to take operational ownership of site management and clinical monitoring across clinical studies.

This is a hands-on role for someone who is comfortable monitoring studies directly, building trusted relationships with investigators and coordinators, and managing several small to mid-sized trials in parallel. Studies may be conducted in Europe, the United States, or both.

Your responsibilities

• Act as Vivalyx’s primary operational contact for investigators and study coordinators.
• Prepare, conduct, and document site initiation, interim on-site and remote monitoring, and closeout visits.
• Perform source data review and verification.
• Track study progress enrollment, follow-up visits, data-entry status, queries, protocol deviations and training needs.
• Review and follow up adverse events, adverse device effects, and device deficiencies.
• Maintain the TMF and support database-lock, audit and inspection readiness.
• Proactively identify risks, resolve operational issues, and escalation when needed.
• Collaborate with cross-functional teams, sites, and CROs to ensure successful study delivery across multiple parallel studies.

Qualifications

• 2+ years of CRA experience preferred, including direct on-site monitoring.
• Experience with medical-device clinical investigations is preferred.
• GCP and ISO 14155 experience required.
• Working knowledge of ICH-GCP required.
• Ability to manage multiple studies and priorities independently in a fast-moving startup environment.
• Clear, pragmatic communicator who can work confidently with investigators, coordinators, CROs, and internal stakeholders.
• Willing and able to travel regularly within Europe and to the United States.
• Fluent in English, both written and spoken (German is a strong plus).

Select benefits

• Company car
• Public transport ticket (Deutschlandticket Job / JobTicket)
• Urban Sports Club membership
• Flexible, mobile working arrangements and flat hierarchies
• Regular opportunities or training and professional development
• Employee stock option program

We look forward to hearing from you.