If you want to be part of a leading CRO and transform scientific discoveries into new treatments, then Parexel FSP challenges you to live up to your potential by joining us at Precision Medicine Operations Lead / SKDL Programming Lead, home-based and sponsor dedicated, in Spain / Poland .
We are looking for hard-working, talented, high-caliber people. We know that employee satisfaction leads to customer satisfaction, which is the ultimate driver of long-term success.
As the company that conducts vital clinical studies for sponsors, including the world's leading biotech’s and top 50 pharmaceutical companies,

we offer
you enormous security and long-term prospects.
You will work from your home office base, supporting studies within their country or region. ‘Manageable sites, manageable protocols’ is our mantra.
Expect exciting professional challenges in inspiring studies, but with time for your outside life.
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 stakeholdersWorks 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 integral 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 in

📌 Precision Medicine Operations Lead (Zaragoza)
🏢 Parexel
📍 Zaragoza