Precision Medicine Operations Lead – SKDL Programming Lead

🔥 1 minute ago

🇵🇱 Poland – Remote

💵 zł250k - zł270k / year

⏰ Full Time

🟠 Senior

⚙️ Operations

👻 Ghost score 0%

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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 • Support clinical study teams as a subject-matter expert on sample management and testing • 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 • Determine how biomarker data is captured, blinded, transferred, and reported • Develop and review data transfer specifications and related documents • Provide guidance and training 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, kits, samples, data operations, vendors, and function-specific metrics • Support precision medicine logistics strategies and evaluate emerging technologies and vendors • Develop tools and dashboards for biomarker sample, kit, logistics, and laboratory data tracking • Aggregate, extract, process, and assess confidential data using technical tools and programming languages • 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 and GCP guidelines • Working knowledge of US FDA and/or local country regulations as applicable • Bachelor's degree in life sciences or equivalent (science, technology, engineering, or mathematics) or relevant work experience • Fluency in spoken and written English • Strong project management and organization skills in a matrix environment • Analytical and problem-solving experience • Excellent written and verbal communication skills • Effective interpersonal and relationship-building skills • Proficiency in Microsoft Office applications, including strong Excel knowledge • Proficiency in Python, R, Perl, SQL or other programming languages, APIs, and Linux/Unix environments if acting as programming lead • Travel not expected but may occur periodically

🏖️ Benefits

• Home-based work from a home office base • Long-term prospects and job security • Time for outside life • Annual performance-based bonus plan for eligible roles • Annual salary review for eligible roles • Total rewards incentives for eligible roles