Precision Medicine Operations Lead – FSP

Job not on LinkedIn

🔥 0 minutes ago

🇭🇺 Hungary – Remote

⏰ Full Time

🟠 Senior

⚙️ Operations

👻 Ghost score 10%

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Participate in cross-functional study team meetings and workstreams to support precision medicine strategy delivery • Support clinical study teams as a subject-matter expert on sample management and testing • Anticipate challenges, manage project risks, and respond to internal and external stakeholder queries • Develop and review sample-related sections of clinical protocols, informed consent forms, and sample management guidelines • Support creation and validation of specialty laboratory databases for data collection and sample kit tracking • Manage biosample process planning and execution, including storage, shipping, and data transfer • Oversee acquisition and testing of clinical trial samples for biomarker research • Liaise with stakeholders on biosample vendors, proposals, bids, and contractual scope • Forecast operational costs and timelines; manage budgeting, invoicing, and reporting • Determine how biomarker data will be captured, blinded, transferred, and reported • Develop and review data transfer specifications and related documents • Guide and train clinical teams and investigative sites on biospecimen collection, storage, and shipment • Ensure human sample transfers are documented, tracked, used, and destroyed according to SOPs and regulations • Oversee clinical trial supplies, logistics, kit inventories, sample tracking, data query resolution, regulatory submissions, import/export documentation, LIMS, and function-specific metrics • Support clinical study logistics strategies, emerging technology evaluation, and vendor evaluation • Develop tools and dashboards for biomarker samples, kits, logistics, and laboratory data when acting as programming lead • Use technical tools, systems, and programming languages to aggregate, extract, process, and assess data • Assess laboratory databases, resolve biomarker data queries, and support database lock activities • Complete required training, timesheets, expense reports, and CV updates • Maintain effective relationships across platform lines, business/research units, and enabling lines

🎯 Requirements

• Minimum of 6 years clinical research experience with academic, Contract Research Organization, pharmaceutical or biotech industry • Working knowledge of clinical drug development process and clinical databases • Working knowledge of ICH, GCP guidelines, and US FDA and/or local country regulations as applicable • Strong project management and organization skills in a matrix environment • Analytical and problem-solving experience • Excellent written and verbal communication skills • Effective communication and interpersonal skills, with proven ability to build relationships internally and externally • Fluent in speaking/writing English • Proficiency in Microsoft Office applications, including strong excel knowledge, as well as relevant role specific systems • Proficiency in Python, R, Perl, SQL or other programming languages, as well as familiarity with APIs and Linux/Unix environments, if acting as programming lead for supplies and laboratory operations • Bachelor degree in life sciences or equivalent (i.e., science, technology, engineering, or mathematics) or relevant work experience • Biology or equivalent major preferred

🏖️ Benefits

• No specific benefits, perks, or compensation extras stated • Travel not expected but may occur periodically