Senior Clinical Research Associate (CRA) - Northern Germany

Rogierwko , Greater Poland Voivodeship, Poland

Type: n/a

Category: Healthcare & Pharma

Requirements: English
Company: Moventas Wind Ltd
Region: Rogierwko , Greater Poland Voivodeship

Senior Clinical Research Associate (CRA) - Northern Germany

Are you our new Excellence Maker?

Join Aurevia in our journey of quality excellence! We are seeking an experienced Senior Clinical Research Associate (CRA) for a full-time position based in Northern Germany. This role requires fluency in English and German and offers the opportunity to work with an international team supporting clinical trials with pharmaceutical, medical devices, and in-vitro devices.

Your Qualifications:

1. Educational Background: Degree in life sciences, pharmacy, biomedicine, or a related field.
2. Experience: At least 5 years of full-time experience as a CRA in clinical trials for pharmaceuticals.
3. Regulatory Knowledge: Strong understanding of ICH-GCP, EU CTR 536/2014, and other applicable pharmaceutical regulations.
4. Authority Coordination: Experience in submitting applications to regulatory authorities.
5. Technical Skills: Proficiency in electronic documentation management systems (eTMF, CTMS, eCRF) and Microsoft 365 tools (Excel, Word, PowerPoint).
6. Soft Skills: Excellent organizational, communication, and problem-solving abilities. Ability to work independently and within a team.
7. Languages: Fluency in German and professional working proficiency in English (oral and written).
8. Travel Readiness: Willingness to travel as required; a valid driver''s license is an advantage.

Your Responsibilities:

1. Act as the primary point of contact for sites and investigators in Germany.
2. Conduct feasibility process and site selection.
3. Plan and execute pre-study, initiation, monitoring, and close-out visits, including reporting and documentation.
4. Train investigators and site staff on study protocols and compliance.
5. Manage site files (ISF) and Trial Master File (TMF).
6. Perform source data verification and ensure compliance with study guidelines.
7. Support contract negotiations and study document preparation.

What We Offer:

1. A dynamic and growing company with modern working practices.
2. Autonomy in your role and the ability to shape your tasks.
3. Flexible work arrangements, including remote work options.
4. Competitive salary and benefits based on experience.
5. An international professional network and opportunities for career growth.

Application Process:

We review applications on a rolling basis and will fill the position as soon as we find the right candidate. If you are interested, please submit your CV, cover letter, and salary expectations by April 24th, 2025. For more details about the position, contact Kirsten Sander, Country Manager (kirsten.sander@aurevia.com).

Apply between 24 February 2025 and 24 April 2025 23:59 (Europe/Berlin).

Aurevia Oy

As Aurevians, we are the excellence makers: a team of experienced experts in healthcare and health-tech standards and quality. Together, we advance healthcare, pharmaceutical and medical technology development with a future-focused approach, aligned with client needs. Driven by our commitment to care, we contribute quality to the industry and pave the way for safer, more effective patient care worldwide.

We are a full-service, rapid-response Contract Research Organization (CRO) and external quality assessment services (EQAS) provider. Our quality services for the healthcare, pharmaceutical, and medical technology industries cover external quality assessments, quality assurance, regulatory affairs, clinical investigations and trials, audits and certifications, and training. Our expertise and knowledge benefit medical device and in vitro diagnostic manufacturers, pharmaceutical companies, healthcare units, and clinical laboratories.

Currently, we serve over 8000 customers in over 60 countries around the world. Our team comprises nearly 200 skilled professionals in offices in Finland, Sweden, Poland, and Germany.

Aurevia empowering clients with excellence-driven solutions to achieve the highest standards in patient care.

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