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At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Precision Medicine Operations Lead/Senior Precision Medicine Operations Lead
Works closely with Precision Medicine Leadership and cross-functional study teams (i.e. clinical, data management, logistics, laboratory vendor management, etc.) to ensure quality samples and data are proficiently managed to support biomarker and non-biomarker evaluation and enable the delivery of science to medicine for the assigned studies. Will work closely with clinical study management and vendors (central and/or specialty laboratories) to perform project management oversight activities concerning sample tracking, usage, collection, destruction and data processing in alignment with the protocol and regulatory requirements.
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.