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Biomarker Sample Operations Associate - III
Mindlance
- 🇺🇸 United States
- Hybrid
- Manager or above
- 13 hours ago
- ICH-GCP
- MS Office
- Excel
- PowerPoint
- PMP
13 hours ago
Describe the primary goals, objectives or functions or outputs of this position.
The Precision Medicine group uses advanced methods to Client biomarkers for use in clinical trials. The Biomarker Sample Operations Associate works closely with operations managers, project managers and laboratory managers to ensure timely and smooth receipt, transfer and testing of clinical trial biomarker specimens in compliance with protocols, regulatory requirements and project timelines. This role is responsible for accessioning and tracking samples in StarLIMS, including labelling, shipping and storage. This role will with work together with laboratory managers and biomarker study management teams to complete tasks. This role will drive innovation and continuous improvement activities in bio-sample collection, processing and transfers, and demonstrate ability to carry out all bio-sample operations with minimal supervision.
Responsibilities:
• Responsible for receipt and tracking of incoming sample shipments, sample accessioning and tracking samples throughout their lifecycle using StarLIMS.
• Coordinate sample processing, labelling, and storage
• Maintain sample storage equipment (Refrigerator/Ultralow/LN2) and monitor equipment functionality and temperature
• Coordinate sample analysis and data transfer. Pull sample inventory reports from various databases and determine the accurate list of samples available for testing.
• Plan, organize and ship biomarker samples from investigator sites or centralized locations and subsequent delivery to assay laboratories or company sites. Ensure timely shipments to vendors and/or storage sites.
• Manage relationships with laboratory vendors, provide input into trial-specific documents and assess service level commitments of labs involved in sample analysis. Ensure issues are resolved or escalated in a timely manner.
• Help project managers with vendor oversight in compliance with company's procedures and applicable regulations.
• In partnership with Clinical Operations, Biomarker Scientists, and IT, contribute to the development, implementation, and management of a sample tracking system for assigned studies.
• Contribute to functional process and system improvements to ensure samples are collected, processed, analyzed, transported, stored, and destroyed appropriately for each assigned study.
• Reconcile data and samples stored in databases.
• Adhere to ICH/GCP, biorepository procedures, biosample management best practices and ethical guidelines.
• Contribute to 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 when needed.
Qualifications:
• Master’s Degree with 3+ years project management, knowledge of oncology, including biomarkers and/or clinical trial experience
• Bachelor’s Degree with 4+ years of project management, knowledge of oncology, including biomarkers and/or clinical trial experience
• Expertise in MS Office applications including Excel, Word and PowerPoint
• Excellent oral and written communication skills in English
• Organization, attention to details and effective time management with an ability to adapt to changing priorities; excellent analytical and interpersonal skills
• PMP certification a plus
• Clinical trial experience
• Scientific background and knowledge of oncology
• Ability to work with minor supervision
EEO:
“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”
Biomarker Sample Operations Associate - III · Mindlance