Biospecimen Specialist

Proclinical; Zug; Hybrid; CHF 90,000 - 130,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Biospecimen acquisition

Data management

LIMS workflows

Regulatory knowledge

GDPR/HIPAA awareness

English proficiency

Project coordination

Education

Bachelor's or Master's in Life Sciences

Job description

Join a team where your expertise in biospecimen acquisition and data integrity helps accelerate breakthroughs in healthcare and research.

Proclinical is seeking a Biospecimen Specialist to join a dynamic team focused on biospecimen acquisition and management. In this role, you will oversee the end-to-end process of biospecimen acquisition and data management, ensuring compliance with regulatory standards and industry best practices. This position offers a hybrid work model, with 60% on-site presence required after onboarding.

We are looking for a motivated and detail-oriented professional who thrives in a collaborative environment and is committed to delivering high-quality results. Strong communication skills and the ability to follow complex protocols are essential for success in this role.

This is role is based in Central Switzerland.

Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.

Responsibilities:

• Biospecimen Acquisition & Compliance: Manage the complete acquisition process, including gathering requirements, developing scopes of work, negotiating vendor agreements, and facilitating purchase requisitions while adhering to quality and compliance standards.
• Data Management & LIMS Operations: Oversee the biospecimen data lifecycle, including data transfer, transcription, quality checks, and discrepancy resolution. Ensure accurate data entry and operations within Laboratory Information Management Systems (LIMS).
• Project Oversight & Stakeholder Engagement: Monitor sample acquisition progress, address issues, and ensure timely and accurate deliverables. Collaborate effectively with internal and external stakeholders to meet project goals.
• Documentation & Regulatory Maintenance: Maintain compliance by accurately collecting and managing legal, regulatory, and ethics documentation as per established procedures.

Key Skills and Requirements:

• Academic background in life sciences (Bachelor's or Master's degree) with relevant experience in sample acquisition, data management, or biobanking.
• Hands
• -on experience in biological sample collection, handling, processing, tracking, and biobanking workflows following standard operating procedures (SOPs).
• Proven ability to manage clinical trial operations, protocols, and deliverables from start-up to completion, adhering to timelines and milestones.
• Strong knowledge of global regulatory frameworks (e.g., FDA, EMA guidelines), Good Clinical Practice (GCP/ICH-GCP), institutional review boards (IRBs/IECs), and bioethical principles.
• Solid understanding of data privacy regulations (e.g., GDPR, HIPAA) related to patient consent, specimen handling, and clinical data integrity.
• Professional proficiency in English (minimum CEFR B2 level or equivalent) with strong written and verbal communication skills.