Hybrid Biospecimen & Data Integrity Specialist

Proclinical; Zug; Híbrido; CHF 90.000 - 130.000; Jornada completa

Descripción de la vacante

Proclinical is seeking a Biospecimen Specialist in Central Switzerland to oversee end-to-end acquisition and data management with a focus on regulatory compliance. The role offers a hybrid work model with 60% on-site presence after onboarding.

The ideal candidate has a life sciences background, hands-on biobanking experience, and strong knowledge of GDPR, GCP, and data integrity. English proficiency at CEFR B2 level is required.

Formación

• Academic background in life sciences with experience in sample acquisition, data management, or biobanking.
• Hands-on experience in biological sample collection, handling, processing, tracking, and biobanking workflows per SOPs.
• Proven ability to manage clinical trial operations, protocols, and deliverables from start-up to completion.
• Strong knowledge of FDA/EMA, GCP/ICH-GCP, IRBs/IECs, and bioethical principles.
• Solid understanding of GDPR/HIPAA data privacy regulations related to patient consent and data integrity.
• Professional proficiency in English (CEFR B2) with strong written and verbal communication skills.

Responsabilidades

• Biospecimen Acquisition & Compliance: Manage the end-to-end acquisition process, vendor agreements, and purchase requisitions with quality controls.
• Data Management & LIMS Operations: Oversee biospecimen data lifecycle, data transfer, transcription, quality checks, and discrepancy resolution in LIMS.
• Project Oversight & Stakeholder Engagement: Monitor progress, address issues, and ensure timely, accurate deliverables with stakeholders.
• Documentation & Regulatory Maintenance: Maintain compliance by collecting and managing legal, regulatory, and ethics documentation.

Conocimientos

Biospecimen acquisition

Data management

LIMS workflows

Regulatory knowledge

GDPR/HIPAA awareness

English proficiency

Project coordination

Educación

Bachelor's or Master's in Life Sciences

Descripción del empleo

Proclinical is seeking a Biospecimen Specialist in Central Switzerland to oversee end-to-end acquisition and data management with a focus on regulatory compliance. The role offers a hybrid work model with 60% on-site presence after onboarding.

The ideal candidate has a life sciences background, hands-on biobanking experience, and strong knowledge of GDPR, GCP, and data integrity. English proficiency at CEFR B2 level is required.