Clinical Laboratory Study Manager (CLSM)

Parexel FSP

Parexel FSP is seeking Clinical Laboratory Study Manager (CLSM) to join our team in Argentina!

Job Summary:

The Clinical Laboratory Study Manager (CLSM) works with Precision Medicine Strategy Lead as well as clinical study teams, data management (DM) team, Samples, Kits, Data, Logistics (SKDL) and Clinical Laboratory Project Management (CLPM) groups to ensure quality samples and data are delivered to support biomarker and non-biomarker evaluation and enable the translation of science to medicine. Responsibilities include oversight of clinical sample collection, usage per informed consent form, sample tracking (chain of custody), management of central laboratory and specialty vendors and sample destruction. Individual will work closely with internal and external groups/vendors to manage and support the generation of quality laboratory data. Will work closely with project managers (central and/or specialty labs) and lend expertise to clinical trial management (CTM) and CRO to ensure samples are collected per protocol and assist with resolving any sample related issues or queries. Additional responsibilities include overall project management in alignment with the core business strategy.

Key Accountabilities:

Study Team Support

• Participates in cross-functional study team meetings and workstreams to support the delivery of the precision medicine strategy for the assigned studies
• Supports clinical study teams as subject-matter expert for technical and operational matters related to sample management and testing, including anticipating challenges, managing risk across projects and responding queries from internal and external stakeholders
• Works with clinical study teams on the development and review of sample-related sections of study-specific documents such as the clinical protocol, Informed Consent Forms (ICFs) and sample management guidelines.
• Supports project management and study set-up teams in the creation and validation of specialty laboratory databases for data collection and sample kit tracking

Operational Support of Biomarker and Exploratory Analysis

• Manages all activities related to biosample process planning and execution, including storage, shipping, and data transfer throughout the study lifecycle
• Oversees the acquisition and testing of clinical trial samples designated for biomarker research (including human tissue, whole blood, plasma, serum, etc.), liaising with relevant stakeholders to assess biosample vendors, review proposals/bids, and define contractual scope.
• Forecasts operational costs and timelines, and manages budgeting, invoicing and reporting for study-related operations

Data Acquisition and Management

• Works closely with data management and biostatistics leads to determine how biomarker data will be captured, blinded, transferred and reported for clinical trials
• Develops and reviews data transfer specifications and related documents

Human Sample Management Flow and Compliance

• Provides guidance and training to clinical teams and investigative sites regarding collection, storage and shipment of biospecimens to ensure compliance with the clinical protocol.
• Works closely with relevant stakeholders to ensure all transfers of human samples are documented, tracked, used and destroyed according to standard operating procedures and regulatory requirements

Clinical Trial Supplies and Logistics

• May have a dedicated role as clinical trial supplies and logistics lead, accountable for samples, kits, data operations and processes/standards related to global logistics and specialty vendor management within precision medicine
• Manage and oversee kit inventories, clinical sample collection, tracking and data query resolution, regulatory submission documents related to kits and samples, global import/export documentation and proforma invoices, maintenance of laboratory information management systems (LIMS) and tracking of function specific metrics
• Support the creation, implementation, monitoring and improvement of clinical study logistics strategies focused on precision medicine deliverables, including evaluating emerging technologies and vendors

Samples, Kits and Laboratory Operations Programming

• May have a dedicated role as programming lead for clinical supplies and laboratory operations, supporting the development of tools and dashboards for tracking biomarker samples, kits, logistics and lab data throughout the study lifecycle.
• Use technical tools, systems and programming languages to systematically aggregate, extract, process and assess data, including confidential data, according to industry standards and function or study-specific guidelines
• Assess laboratory databases, resolve queries for biomarker data and support data management leads in database lock activities.

Compliance with Parexel Standards

• Complies with timely completion of required training curriculum
• Completes timesheets accurately as required
• Submits expense reports as required
• Updates CV as required
• Maintains effective relationships with other platform lines, Business Units/Research Units, and enabling lines that facilitate effective portfolio delivery

Skills:

• 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
• Travel not expected but may occur periodically
• 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, as well as familiarity with APIs and Linux/Unix environments, if acting as programming lead for supplies and laboratory operations

Knowledge and Experience:

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

Education:

• Requires bachelor degree in life sciences or equivalent (i.e., science, technology, engineering, or mathematics) or relevant work experience. Biology or equivalent major preferred.

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