Clinical Laboratory Study Manager – FSP

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

📋 Description

• Collaborate effectively with Precision Medicine Leadership and interdisciplinary study teams to ensure the management of high-quality samples and data that support both biomarker and non-biomarker assessments.

• Provide oversight in project management for sample tracking, utilization, collection, destruction, and data processing, ensuring alignment with protocols and regulatory standards.

• Engage in interdisciplinary study team meetings and workstreams that bolster precision medicine strategies.

• Act as a subject-matter expert in sample management and testing, proactively identifying challenges, managing project risks, and addressing stakeholder inquiries.

• Create and review sections related to samples in clinical protocols, Informed Consent Forms, and guidelines for sample management.

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

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

• Supervise the acquisition and testing of clinical trial samples for biomarker research while coordinating with vendors and stakeholders.

• Project operational costs and timelines; manage budgeting, invoicing, and reporting processes.

• Collaborate with data management and biostatistics leads on biomarker data capture, blinding, transfer, and reporting tasks.

• Create and review specifications for data transfer and associated documents.

• Train clinical teams and investigative sites on the compliance of biospecimen collection, storage, and shipment.

• Ensure that the transfer of human samples is documented, tracked, utilized, and destroyed according to SOPs and regulatory requirements.

• Potentially oversee clinical trial supplies and logistics, which includes managing sample and kit inventories, vendor management, documentation, and LIMS tracking.

• Support strategies for precision medicine logistics and evaluate emerging technologies and vendors.

• Potentially lead the programming for clinical supplies and laboratory operations, developing tools and dashboards.

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

• Review laboratory databases, resolve queries related to biomarker data, and support activities related to database locking.

• Complete necessary training, timesheets, expense reports, and updates to CVs.

• Maintain strong relationships across various business and research units as well as enabling lines.

⛳️ Requirements

• Candidates must reside in Argentina.

• A minimum of 6 years of clinical research experience within academic, Contract Research Organizations, pharmaceutical, or biotech industries.

• Proficient understanding of the clinical drug development process and clinical databases.

• Familiarity with ICH, GCP guidelines, and US FDA and/or local country regulations as applicable.

• Bachelor's degree in life sciences or a related field (e.g., science, technology, engineering, or mathematics) or relevant work experience.

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

• Exceptional project management and organizational skills in a matrixed environment.

• Experience in analytical thinking and problem-solving.

• Outstanding written and verbal communication abilities.

• Strong communication and interpersonal skills with a proven track record of building relationships both internally and externally.

• Proficient in English, both spoken and written.

• Expertise in Microsoft Office applications, particularly strong knowledge of Excel, as well as relevant role-specific systems.

• Proficient in programming languages such as Python, R, Perl, SQL, or others, with familiarity in APIs and Linux/Unix environments, especially if serving as a programming lead for supplies and laboratory operations.

🏝️ Benefits

• No specific benefits or compensation details provided.

• Full-time employment opportunity.

• Travel is not anticipated but may occur on occasion.