When our values align, there's no limit to what we can achieve.
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.
Key Accountabilities: Study Team SupportParticipates in cross-functional study team meetings and workstreams to support the delivery of the precision medicine strategy for the assigned studiesSupports 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 trackingOperational Support of Biomarker and Exploratory AnalysisManages all activities related to biosample process planning and execution, including storage, shipping, and data transfer throughout the study lifecycleOversees 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 operationsData Acquisition and ManagementWorks closely with data management and biostatistics leads to determine how biomarker data will be captured, blinded, transferred and reported for clinical trialsDevelops and reviews data transfer specifications and related documentsHuman Sample Management Flow and ComplianceProvides 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 requirementsClinical Trial Supplies and LogisticsMay 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 medicineManage 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 metricsSupport the creation, implementation, monitoring and improvement of clinical study logistics strategies focused on precision medicine deliverables, including evaluating emerging technologies and vendorsSamples, Kits and Laboratory Operations ProgrammingMay 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 guidelinesAssess laboratory databases, resolve queries for biomarker data and support data management leads in database lock activities.
Compliance with Parexel StandardsComplies with timely completion of required training curriculumCompletes timesheets accurately as requiredSubmits expense reports as requiredUpdates CV as requiredMaintains effective relationships with other platform lines, Business Units/Research Units, and enabling lines that facilitate effective portfolio deliverySkills: Strong project management and organization skills in a matrix environmentAnalytical and problem-solving experienceExcellent written and verbal communication skillsEffective communication and interpersonal skills, with proven ability to build relationships internally and externallyFluent in speaking/writing EnglishTravel not expected but may occur periodicallyProficiency in Microsoft Office applications, including strong excel knowledge, as well as relevant role specific systemsProficiency 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 operationsKnowledge and Experience: Minimum of 6 years clinical research experience with academic, Contract Research Organization, pharmaceutical or biotech industryWorking knowledge of clinical drug development process and clinical databases, as well as ICH, GCP guidelines, and US FDA and/or local country regulations as applicableEducation: Requires bachelor degree in life sciences or equivalent (i.e., science, technology, engineering, or mathematics) or relevant work experience. Biology or equivalent major preferred.
SummaryLocation: United Kingdom-Harrow-RemoteType:
Precision Medicine Operations Lead - FSP in Harrow employer: PAREXEL
At Parexel, we pride ourselves on being an exceptional employer, offering a collaborative work culture that fosters innovation and professional growth. Our team members enjoy competitive benefits, including flexible working arrangements and opportunities for career advancement, all while contributing to impactful global clinical trials in a supportive environment across the UK, Poland, Serbia, and Hungary.
