Biomarker Sample Operations Associate - III

Actalent; North Chicago (IL); Presencial; USD 75 000 - 110 000; Tempo integral

Resumo da oferta

Actalent is seeking a Biomarker Sample Operations Associate III to support the Precision Medicine group in handling clinical trial biomarker specimens from receipt to final disposition. You will oversee accessioning, labeling, shipping, storage, and data reconciliation in StarLIMS and collaborate with cross-functional teams in a fast-paced environment.

Responsibilities include coordinating sample processing, maintaining storage equipment, and ensuring regulatory compliance while driving process

Qualificações

• Bachelor's degree with 4+ years in PM, oncology, or clinical trial ops.
• Masters with 3+ years in similar areas is acceptable.
• Experience with LIMS and biosample workflows is required.

Responsabilidades

• Receive and accession samples using StarLIMS and track lifecycle.
• Coordinate processing, labeling, and storage per study protocols.
• Maintain and monitor freezers and LN2 to protect sample integrity.
• Plan and ship samples to labs or internal sites ensuring timely delivery.
• Manage vendor relationships and oversee lab services for compliance.

Conhecimentos

Project management

Oncology/biomarkers knowledge

Clinical trial operations

Independent work

Organizational skills

Analytical skills

Interpersonal skills

Formação académica

Bachelor's degree with ≥4 years experience

Master's degree with ≥3 years experience

Ferramentas

StarLIMS

MS Office

Descrição da oferta de emprego

Job Title: Biomarker Sample Operations Associate III Job Description

The Biomarker Sample Operations Associate supports the Precision Medicine group by ensuring the timely and compliant receipt, processing, tracking, and transfer of clinical trial biomarker specimens. Working closely with operations managers, project managers, laboratory managers, Clinical Operations, Biomarker Scientists, and IT, this role oversees the full lifecycle of biosamples using StarLIMS, including accessioning, labelling, shipping, storage, and data reconciliation. The associate helps drive innovation and continuous improvement in biosample collection and handling processes, and is expected to perform all biosample operations with minimal supervision in a fast-paced, team-based environment.

Responsibilities

• Receive incoming biomarker sample shipments and perform sample accessioning while accurately tracking samples throughout their lifecycle using StarLIMS.
• Coordinate sample processing, labelling, and storage to ensure specimens are handled in accordance with study protocols and regulatory requirements.
• Maintain sample storage equipment, including refrigerators, ultralow freezers, and liquid nitrogen (LN2) units, and monitor equipment functionality and temperature to safeguard sample integrity.
• Coordinate sample analysis and data transfer by pulling sample inventory reports from various databases and determining accurate lists of samples available for testing.
• Plan, organize, and ship biomarker samples from investigator sites or centralized locations to assay laboratories or internal sites, ensuring timely delivery to vendors and storage facilities.
• Manage relationships with laboratory vendors, provide input into trial-specific documents, and assess service level commitments for labs involved in sample analysis, escalating issues when necessary.
• Support project managers with vendor oversight to ensure compliance with internal procedures and applicable regulations.
• Partner with Clinical Operations, Biomarker Scientists, and IT to contribute to the development, implementation, and management of sample tracking systems for assigned studies.
• Contribute to functional process and system improvements to ensure samples are appropriately collected, processed, analyzed, transported, stored, and destroyed for each assigned study.
• Reconcile data and physical samples stored in databases, ensuring accurate records and traceability.
• Adhere to ICH/GCP guidelines, biorepository procedures, biosample management best practices, and ethical standards related to biospecimen handling.
• Foster a positive and motivating work environment that encourages mutual respect, innovation, and accountability at all levels.
• Balance multiple priorities in a fast-paced, team-based environment and work independently with minimal supervision when needed.

Essential Skills

• Bachelors degree with at least 4 years of experience in project management, oncology (including biomarkers), and/or clinical trial operations, or a Masters degree with at least 3 years of similar experience.
• Hands-on experience with a Laboratory Information Management System (LIMS), preferably StarLIMS, including sample accessioning and lifecycle tracking.
• Practical experience in sample labelling, processing, and storage within a laboratory or sample management setting.
• Experience working with freezers and low-temperature storage, including ultralow freezers and liquid nitrogen (LN2), and monitoring temperature-controlled equipment.
• Demonstrated clinical trial experience and familiarity with biosample workflows in oncology and biomarker-driven studies.
• Scientific background and working knowledge of oncology and biomarkers.
• Ability to work with minor supervision, taking ownership of tasks and managing day-to-day operations independently.
• Strong organizational skills, attention to detail, and effective time management with the ability to adapt to changing priorities.
• Solid analytical and interpersonal skills to resolve issues, collaborate across functions, and manage vendor relationships.

Additional Skills & Qualifications

• Proficiency in MS Office applications, including Excel, Word, and PowerPoint.
• Excellent oral and written communication skills in English.
• Project Management Professional (PMP) certification is a plus.
• Experience freezing and handling specimens for long-term storage.
• Prior experience in sample management and laboratory operations, even at entry level, is beneficial.
• Ability to contribute to process improvement initiatives and continuous innovation in biosample operations.

Work Environment

This position is based 100% onsite in Lake County at an AP9 facility and operates in a laboratory and biorepository setting focused on clinical trial biomarker specimens. The role involves frequent interaction with laboratory equipment such as refrigerators, ultralow freezers, and liquid nitrogen (LN2) storage units, as well as regular use of StarLIMS and other databases for sample tracking and data reconciliation. Work is performed in a fast-paced, team-oriented environment that emphasizes collaboration with operations managers, project managers, laboratory managers, Clinical Operations, Biomarker Scientists, and IT. The culture promotes mutual respect, innovation, accountability, and continuous improvement in biosample collection, processing, and transfer. Standard laboratory and office technologies are used daily, including MS Office tools for documentation and reporting. Appropriate laboratory attire and adherence to safety procedures are expected when working in sample processing and storage areas.

Job Type & Location

This is a Contract position based out of North Chicago, IL.

Pay and Benefits