Clinical Biomarker Operations Specialist (m/f/d)

CatalYm GmbH; Krailling; Hybrid; EUR 65.000 - 90.000; Vollzeit

Benefits dieser Stelle

Flexible working arrangements

Permanent contract

Competitive compensation

Employee benefits

Zusammenfassung

CatalYm GmbH is seeking a Clinical Biomarker Operations Specialist to support planning, coordination, and execution of biomarker and bioanalytical activities across clinical trials. You will drive vendor qualification, data transfers, and documentation to ensure timely, high-quality deliverables at CatalYm’s Martinsried site.

You will collaborate with Translational Research, Clinical Development, Clinical Operations, and external labs/CROs, ensuring compliant study execution and robust

Qualifikationen

• University degree in life sciences, biomedical sciences, clinical research, biotechnology, pharmacy, or a related discipline.
• 2-5 years of experience in clinical trial operations, biomarker operations, clinical sample management, central laboratory operations, or a related operational role.
• Good understanding of clinical trial workflows, including sample collection, processing, shipment, tracking, reconciliation, laboratory testing coordination, and data delivery.
• Experience managing external vendors such as central laboratories, specialty laboratories, or CROs.
• Experience with vendor qualification and onboarding, contracting processes and day-to-day vendor coordination within clinical trials.
• Familiarity with clinical trial documentation, including protocols, laboratory manuals, sample handling instructions, vendor scopes of work, data transfer specifications, and operational plans.
• Good understanding of GCP, clinical trial quality requirements, sample traceability, vendor oversight, and documentation standards.
• Experience working in oncology clinical trials and/or biomarker-related clinical studies is preferred.
• Strong organisational skills with the ability to coordinate multiple studies, timelines, and stakeholders in simultaneously.
• Structured, detail-oriented, proactive, and able to identify operational issues and proactively work with colleagues to resolve them.
• Excellent communication and collaboration skills, with the ability to work effectively across clinical, operational, laboratory, legal/procurement, and external partner teams.

Aufgaben

• Support the operational implementation and day-to-day coordination of clinical biomarker, translational sample, and bioanalytical activities across ongoing clinical trials.
• Coordinate biomarker-related trial activities, including sample collection, processing, shipment, tracking, reconciliation , laboratory testing coordination, and data transfers.
• Contribute to the preparation, maintenance, and updates of biomarker- and bioanalytics-related clinical trial documents, including protocols, laboratory manuals, sample handling instructions, and vendor documentation.
• Support operational set-up activities, including vendor identification, vendor qualification, contracting support, study start-up, sample logistics, assay readiness tracking, data transfer processes, and report delivery.
• Coordinate activities with external vendors, specialty laboratories, central laboratories, CROs, and other service providers involved in sample handling, biomarker testing, bioanalytical testing, data delivery, and reporting.
• Monitor biomarker and bioanalytical activitiesto help ensure execution according to study timelines, protocol requirements, and applicable quality standards.
• Track operational milestones, risks, issues, and dependencies, and escalated issues and support resolution in collaboration with internal functions and external partners.
• Review vendor deliverables for completeness and quality and follow up on outstanding items where needed.
• Facilitate cross-functional communication between internal functions, external partners, clinical sites, central laboratories, and specialty laboratories.
• Maintain clear documentation of operational plans, decisions, vendor communications, sample status, data transfers, contracts, study-level deliverables, and open issues.
• Support budget tracking, purchase orders, contracts, change orders, and invoice review for biomarker- and bioanalytics-related vendors.
• Contribute to continuous improvement of biomarker and bioanalytical operations processes, templates, vendor oversight practices, and cross-functional ways of working.

Kenntnisse

GCP knowledge

Vendor management

Biomarker operations

Communication

Organizational skills

Ausbildung

Life sciences degree

Jobbeschreibung

Your mission

As Clinical Biomarker Operations Specialist, you will support operational planning, coordination, and execution of clinical biomarker, translational sample, and bioanalytical activities across CatalYm’s clinical trials. You will help ensure that biomarker-related trial activities are implemented reliably, samples are collected and processed according to protocol requirements, vendors are qualified, contracted, and managed effectively, and biomarker and bioanalytical deliverables are completed on time and to a high standard.

Your mission

As Clinical Biomarker Operations Specialist, you will support operational planning, coordination, and execution of clinical biomarker, translational sample, and bioanalytical activities across CatalYm’s clinical trials. You will help ensure that biomarker-related trial activities are implemented reliably, samples are collected and processed according to protocol requirements, vendors are qualified, contracted, and managed effectively, and biomarker and bioanalytical deliverables are completed on time and to a high standard.

You will work closely with Translational Research, Clinical Development, Clinical Operations, Clinical Pharmacology and Bioanalytics, Data Management, Biostatistics, Regulatory Affairs, Legal/Procurement, external laboratories, central laboratories, and CROs to support robust operational delivery of the clinical biomarker & bioanalytical program.

Your responsibilities include

• Support the operational implementation and day-to-day coordination of clinical biomarker, translational sample, and bioanalytical activities across ongoing clinical trials.
• Coordinate biomarker-related trial activities, including sample collection, processing, shipment, tracking, reconciliation , laboratory testing coordination, and data transfers.
• Contribute to the preparation, maintenance, and updates of biomarker- and bioanalytics-related clinical trial documents, including protocols, laboratory manuals, sample handling instructions, and vendor documentation.
• Support operational set-up activities, including vendor identification, vendor qualification, contracting support, study start-up, sample logistics, assay readiness tracking, data transfer processes, and report delivery.
• Coordinate activities with external vendors, specialty laboratories, central laboratories, CROs, and other service providers involved in sample handling, biomarker testing, bioanalytical testing, data delivery, and reporting.
• Monitor biomarker and bioanalytical activitiesto help ensure execution according to study timelines, protocol requirements, and applicable quality standards.
• Track operational milestones, risks, issues, and dependencies, and escalated issues and support resolution in collaboration with internal functions and external partners.
• Review vendor deliverables for completeness and quality and follow up on outstanding items where needed.
• Facilitate cross-functional communication between internal functions, external partners, clinical sites, central laboratories, and specialty laboratories.
• Maintain clear documentation of operational plans, decisions, vendor communications, sample status, data transfers, contracts, study-level deliverables, and open issues.
• Support budget tracking, purchase orders, contracts, change orders, and invoice review for biomarker- and bioanalytics-related vendors.
• Contribute to continuous improvement of biomarker and bioanalytical operations processes, templates, vendor oversight practices, and cross-functional ways of working.

Your profile

Who you are

• University degree in life sciences, biomedical sciences, clinical research, biotechnology, pharmacy, or a related discipline.
• 2-5 years of experience in clinical trial operations, biomarker operations, clinical sample management, central laboratory operations, or a related operational role.
• Good understanding of clinical trial workflows, including sample collection, processing, shipment, tracking, reconciliation, laboratory testing coordination, and data delivery.
• Experience managing external vendors such as central laboratories, specialty laboratories, or CROs.
• Experience with vendor qualification and onboarding, contracting processes and day-to-day vendor coordination within clinical trials.
• Familiarity with clinical trial documentation, including protocols, laboratory manuals, sample handling instructions, vendor scopes of work, data transfer specifications, and operational plans.
• Good understanding of GCP, clinical trial quality requirements, sample traceability, vendor oversight, and documentation standards.
• Experience working in oncology clinical trials and/or biomarker-related clinical studies is preferred.
• Strong organisational skills with the ability to coordinate multiple studies, timelines, and stakeholders in simultaneously.
• Structured, detail-oriented, proactive, and able to identify operational issues and proactively work with colleagues to resolve them.
• Excellent communication and collaboration skills, with the ability to work effectively across clinical, operational, laboratory, legal/procurement, and external partner teams.

Why us?

What we offer

• The opportunity to contribute to the clinical development of a promising, innovative cancer therapy.
• An operational role at the interface of translational research, clinical biomarkers, clinical operations, and clinical bioanalytics.
• A collaborative and purpose-driven team environment.
• Flexible working arrangements, including partial remote work while maintaining regular on-site collaboration.
• A secure, permanent employment contract with competitive compensation and attractive employee benefits.

About Us

CatalYm is a biotech company based in Martinsried near Munich, developing innovative immunotherapies to transform cancer patients’ lives by effectively engaging their own immune systems to combat this malignant disease. We are now advancing to Phase 2b studies to confirm visugromab, our lead antibody, that has demonstrated durable anti-tumor efficacy with long-lasting objective responses in relapsed and refractory metastatic solid tumor patients in combination with anti-PD-1 treatment. Our mission is to rapidly bring our next-generation immuno-oncology products to patients in need. Are you ready to board the fast-accelerating visugromab train in Martinsried? Then join us!