Precision Medicine Operations Lead - FSP

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Engage in cross-functional study team meetings and workstreams to facilitate the execution of precision medicine strategies.

• Serve as a subject-matter expert for sample management and testing to assist clinical study teams, proactively identifying challenges, managing project risks, and addressing stakeholder inquiries.

• Create and review sections related to samples in protocols, Informed Consent Forms, and sample management guidelines.

• Aid in the creation and validation of specialized laboratory databases for the collection of data and tracking of sample kits.

• Oversee the planning and execution of the biosample process, including storage, shipping, and data transfer throughout the study lifecycle.

• Supervise the acquisition and testing of clinical trial samples for biomarker research, coordinating with vendors and stakeholders.

• Anticipate operational costs and timelines; oversee budgeting, invoicing, and reporting activities.

• Collaborate with data management and biostatistics leads on the capture, blinding, transfer, and reporting of biomarker data.

• Develop and review specifications for data transfer and associated documentation.

• Provide expertise and training on the collection, storage, and shipment of biospecimens.

• Ensure that transfers of human samples are properly documented, tracked, utilized, and disposed of according to SOPs and regulations.

• Lead or assist in the logistics of clinical trial supplies, including samples, kits, data operations, global logistics, and management of specialized vendors.

• Manage inventories of kits, sample collection and tracking, resolution of data queries, regulatory documents, import/export documentation, LIMS, and function-specific metrics.

• Develop, implement, monitor, and enhance clinical study logistics strategies for precision medicine deliverables.

• Assist in the creation of tools and dashboards for managing biomarker samples, kits, logistics, and laboratory data.

• Utilize technical tools, systems, and programming languages to aggregate, extract, process, and evaluate data.

• Evaluate laboratory databases, resolve queries related to biomarker data, and support activities related to database locks.

• Complete all required training, timesheets, expense reports, and updates to CVs.

• Foster effective relationships across various platform lines, research/business units, and enabling lines.

⛳️ Requirements

• Strong project management and organizational skills in a matrix environment.

• Experience in analytical thinking and problem-solving.

• Exceptional written and verbal communication skills.

• Proficient communication and interpersonal abilities, with a demonstrated capacity to build relationships both internally and externally.

• Proficient in English, both spoken and written.

• Travel is not anticipated but may occur occasionally.

• Proficient in Microsoft Office applications, particularly with advanced Excel skills, as well as relevant role-specific systems.

• Proficient in programming languages such as Python, R, Perl, SQL, or others, along with familiarity with APIs and Linux/Unix environments, if serving as the programming lead for supplies and laboratory operations.

• At least 6 years of experience in clinical research, particularly in academic settings, Contract Research Organizations, pharmaceutical, or biotech industries.

• Familiarity with the clinical drug development process and clinical databases, as well as knowledge of ICH, GCP guidelines, and US FDA and/or local regulations as applicable.

• Bachelor’s degree in life sciences or an equivalent field (such as science, technology, engineering, or mathematics) or relevant work experience is required.

• A major in Biology or a related field is preferred.

🏝️ Benefits

• No explicit benefits, perks, or compensation extras stated.