Clinical Laboratory Study Manager – FSP

🔥 0 minutes ago

🇦🇷 Argentina – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

👻 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

• Work closely with Precision Medicine Leadership and cross-functional study teams to ensure quality samples and data are managed to support biomarker and non-biomarker evaluation • Provide project management oversight for sample tracking, usage, collection, destruction and data processing in alignment with protocols and regulatory requirements • Participate in cross-functional study team meetings and workstreams supporting precision medicine strategy • Serve as subject-matter expert on sample management and testing, anticipating challenges, managing project risks and responding to stakeholder queries • Develop and review sample-related sections of clinical protocols, Informed Consent Forms and sample management guidelines • Support specialty laboratory database creation and validation 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 and liaise with vendors and stakeholders • 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 • 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 • Potentially lead clinical trial supplies and logistics, including sample and kit inventories, logistics, vendor management, documentation and LIMS tracking • Support precision medicine logistics strategies and evaluate emerging technologies and vendors • Potentially lead programming for clinical supplies and laboratory operations, developing tools and dashboards • 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

• Candidates must be based in Argentina • 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 • 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, as well as 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

🏖️ Benefits

• No explicit benefits or compensation extras stated • Full-time employment • Travel not expected but may occur periodically