Precision Medicine Operations Lead – SKDL Programming Lead

🔥 2 hours ago

🇪🇸 Spain – 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 supporting precision medicine strategy delivery • Provide subject-matter expertise on sample management and testing, anticipate challenges, manage project risk, and respond to 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 • Assess biosample vendors, review proposals and bids, and define contractual scope • Forecast operational costs and timelines; manage budgeting, invoicing, and reporting • Coordinate with data management and biostatistics leads on biomarker data capture, blinding, transfer, and reporting • Develop and review data transfer specifications and related documents • Guide and train clinical teams and investigative sites on biospecimen collection, storage, and shipment compliance • Ensure human sample transfers are documented, tracked, used, and destroyed according to SOPs and regulations • Manage clinical trial supplies and logistics, including samples, kits, data operations, and specialty vendor management • Oversee kit inventories, sample collection and tracking, data query resolution, regulatory submission documents, import/export documentation, proforma invoices, LIMS, and functional metrics • Support creation, implementation, monitoring, and improvement of clinical study logistics strategies • Develop tools and dashboards for tracking biomarker samples, kits, logistics, and laboratory data • 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, business, research, and enabling lines

🎯 Requirements

• Minimum of 6 years clinical research experience with academic, Contract Research Organization, pharmaceutical or biotech industry • Working knowledge of the clinical drug development process and clinical databases • Working knowledge of ICH, GCP guidelines, and US FDA and/or local country regulations as applicable • Bachelor degree in life sciences or equivalent (i.e., science, technology, engineering, or mathematics) or relevant work experience • Biology or equivalent major preferred • 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, and relevant role-specific systems • Proficiency in Python, R, Perl, SQL or other programming languages, familiarity with APIs and Linux/Unix environments, if acting as programming lead for supplies and laboratory operations • Travel not expected but may occur periodically

🏖️ Benefits

• Home-based work from a home office • Long-term prospects and job security • Time for outside life • Professional challenges and opportunities to contribute to clinical development