Clinical Laboratory Study Manager – FSP

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

📋 Description

• Collaborate with the Precision Medicine Strategy Lead, clinical study teams, data management team, Samples, Kits, Data, Logistics (SKDL), and Clinical Laboratory Project Management (CLPM) groups to guarantee high-quality samples and data that support both biomarker and non-biomarker evaluations.

• Supervise the collection of clinical samples, ensuring adherence to informed consent forms, as well as managing sample tracking and chain of custody.

• Oversee the central laboratory and specialty vendors, including the process of sample destruction.

• Assist in generating quality laboratory data and addressing any sample-related issues or inquiries.

• Engage in cross-functional study team meetings and workstreams.

• Provide expertise on sample management and testing, proactively anticipating challenges, managing risks, and addressing stakeholder inquiries.

• Develop and review the sample-related sections of clinical protocols, Informed Consent Forms, and sample management guidelines.

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

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

• Supervise the acquisition and testing of clinical trial samples for biomarker research purposes.

• Evaluate biosample vendors, review proposals/bids, and define the contractual scope of work.

• Predict operational costs and timelines; manage budgeting, invoicing, and reporting tasks.

• Determine the processes for capturing, blinding, transferring, and reporting biomarker data.

• Develop and review data transfer specifications and associated documentation.

• Provide guidance and training to clinical teams and investigative sites regarding biospecimen collection, storage, and shipment procedures.

• Ensure that human sample transfers are documented, tracked, utilized, and destroyed in accordance with SOPs and regulatory requirements.

• Manage clinical trial supplies and logistics, including kit inventories, sample tracking, regulatory submission documents, and global import/export documentation.

• Maintain laboratory information management systems and monitor function-specific metrics.

• Support logistics strategies, technology, and vendor evaluations.

• Develop tools and dashboards for biomarker samples, kits, logistics, and laboratory data while acting as the programming lead.

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

• Evaluate laboratory databases, resolve biomarker data queries, and assist with database lock activities.

• Complete necessary training, timesheets, expense reports, and CV updates.

• Foster effective relationships across platform, business, research, and enabling lines.

⛳️ Requirements

• Strong project management and organizational skills in a matrix environment.

• Experience in analytical thinking and problem-solving.

• Exceptional written and verbal communication abilities.

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

• Proficient in spoken and written English.

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

• Proficient in programming languages such as Python, R, Perl, SQL, or others; familiarity with APIs and Linux/Unix environments is preferred if acting as the programming lead for supplies and laboratory operations.

• A minimum of 6 years of clinical research experience in academic settings, Contract Research Organizations, or the pharmaceutical and biotech industries.

• Working knowledge of the clinical drug development process and clinical databases.

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

• A bachelor’s degree in life sciences or an equivalent field (i.e., science, technology, engineering, or mathematics) or relevant work experience is required.

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

🏝️ Benefits

• No specific benefits or compensation extras mentioned.

• Travel is not anticipated but may occur occasionally.