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 .

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 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 integral 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

Proficiency in Python, R, MATLAB, and/or SQL programming is required.

Proficiency in one or more programming languages (R, Python, Perl, SQL, MATLAB)

Familiarity with APIs, database development, dashboard development, and Linux/Unix environments Clinical trial data experience: Hands-on work with clinical trial operational data, such as EDC and vendor or laboratory datasets, and familiarity with how studies are executed.

Pharma, biotech, or CRO background: Direct industry exposure, ideally in clinical operations, biomarker, or laboratory settings, so the onboarding curve is shorter.

Technical skills: Strong backend and API development, data pipelines, and automation experience, along with the ability to build and standardize data processes.

Clear ownership: Candidates who can speak specifically to their own contributions and explain how their experience would transfer to a new domain.

Curiosity and collaboration: Genuine interest in the role and team, and strong examples of working cross-functionally.

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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📌 SKDL Programming Lead - Spain - FSP (Sevilla)
🏢 Parexel
📍 Sevilla