Precision Medicine Operations Lead - FSP

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.

Work arrangement
Yes