SKDL Programming Lead - Poland - FSP

Parexel; Madrid; Remote; EUR 57,000 - 62,000; Full time

Benefits offered by this job

Bonus plan

Annual salary review

Total rewards incentives

Job summary

Parexel FSP is seeking a Precision Medicine Operations Lead / SKDL Programming Lead to work from a home-based base in Spain or Poland. The role focuses on biosample management, data transfer, and biomarker analysis within a global precision medicine program.

You will manage study operations, budgets, and vendor assessments while collaborating with clinical teams, data management and biostatistics leads. Fluency in English and strong programming knowledge are essential.

Qualifications

• Minimum 6 years of clinical research experience across CRO/pharma/biotech.
• Bachelor's degree in life sciences or equivalent; biology or related major preferred.
• Fluent in English, strong communication and stakeholder management skills.
• Experience with sample management, biomarker testing, data transfer and LIMS is beneficial.

Responsibilities

• Lead cross-functional study teams to support precision medicine strategy.
• Oversee biosample planning, storage, shipping and data transfer.
• Manage budgeting, invoicing and reporting for study operations.
• Develop and review data transfer specs and lab-related documents.
• Provide guidance on compliance with regulatory requirements.

Skills

Project management

English fluency

Analytical thinking

Communication skills

Cross-functional collaboration

Biomarker analysis

Education

Bachelor degree in life sciences or equivalent

Biology or related major preferred

Tools

Python

R

SQL

Linux/Unix

Job description

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 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.

Base Pay Range for Poland: 250,000 - 270,000 PLN gross annual

Actual salaries may vary within the range based on several factors including, but not limited to education, training, experience, professional achievement, and location.

In addition to base salary, some roles may be eligible for participation in Parexel’s annual performance-based bonus plan, annual salary review and total rewards incentives.

Our talent acquisition team will provide additional details on our bonus plan or incentive programs for those eligible roles.