Precision Medicine Operations Lead – FSP

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

📋 Description

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

• Act as a subject-matter expert on sample management and testing to support clinical study teams.

• Proactively identify challenges, manage project risks, and address inquiries from both internal and external stakeholders.

• Create and review sample-related sections of clinical protocols, informed consent documents, and sample management guidelines.

• Assist in the development and validation of specialty laboratory databases for data collection and tracking of sample kits.

• Oversee the planning and execution of the biosample process, encompassing storage, shipping, and data transfer.

• Supervise the acquisition and testing of clinical trial samples for biomarker research purposes.

• Coordinate with stakeholders regarding biosample vendors, proposals, bids, and contractual scope.

• Predict operational costs and timelines; manage budgeting, invoicing, and reporting activities.

• Define how biomarker data will be captured, blinded, transferred, and reported.

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

• Train and guide clinical teams and investigative sites on biospecimen collection, storage, and shipment procedures.

• Ensure that human sample transfers are documented, tracked, utilized, and disposed of in accordance with SOPs and regulations.

• Manage clinical trial supplies, logistics, kit inventories, sample tracking, data query resolution, regulatory submissions, import/export documentation, LIMS, and function-specific metrics.

• Support the strategies for clinical study logistics, evaluate emerging technologies, and assess vendors.

• Create tools and dashboards for biomarker samples, kits, logistics, and laboratory data when serving as the programming lead.

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

• Evaluate laboratory databases, resolve biomarker data queries, and assist in database lock activities.

• Complete mandatory training, timesheets, expense reports, and CV updates.

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

⛳️ Requirements

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

• Familiarity with the clinical drug development process and clinical databases.

• Knowledge of ICH, GCP guidelines, and US FDA/local country regulations as applicable.

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

• Experience in analytical thinking and problem-solving.

• Excellent written and verbal communication abilities.

• Effective interpersonal skills, with a proven capacity to develop relationships both internally and externally.

• Proficient in English, both spoken and written.

• Expertise in Microsoft Office applications, particularly strong Excel skills, as well as familiarity with role-specific systems.

• Proficiency in programming languages such as Python, R, Perl, SQL, or others, along with knowledge of APIs and Linux/Unix environments, especially if serving as the programming lead for supplies and lab operations.

• Bachelor’s degree in life sciences or an equivalent field (e.g., science, technology, engineering, or mathematics) or relevant work experience.

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

🏝️ Benefits

• No specific benefits, perks, or additional compensation details provided.

• Travel is not anticipated but may occur occasionally.