[Hiring] Precision Medicine Operations Lead / SKDL Programming Lead @Parexel

Role Description

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.

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.
  • Works with clinical study teams on the development and review of sample-related sections of study-specific documents.
  • Supports project management and study set-up teams in the creation and validation of specialty laboratory databases.
• Operational Support of Biomarker and Exploratory Analysis
  • Manages all activities related to biosample process planning and execution.
  • Oversees the acquisition and testing of clinical trial samples designated for biomarker research.
  • 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.
  • 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.
  • Works closely with relevant stakeholders to ensure all transfers of human samples are documented, tracked, used and destroyed according to standard operating procedures.
• Clinical Trial Supplies and Logistics
  • May have a dedicated role as clinical trial supplies and logistics lead.
  • Manage and oversee kit inventories, clinical sample collection, tracking and data query resolution.
  • Support the creation, implementation, monitoring and improvement of clinical study logistics strategies.
• Samples, Kits and Laboratory Operations Programming
  • May have a dedicated role as programming lead for clinical supplies and laboratory operations.
  • Use technical tools, systems and programming languages to systematically aggregate, extract, process and assess data.
  • 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.

Qualifications

• 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.
• Proficiency in Microsoft Office applications, including strong Excel knowledge.
• Proficiency in Python, R, Perl, SQL or other programming languages.
• 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.
• Knowledge of 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.

Compensation

• Base Pay Range for Poland: 250,000 - 270,000 PLN gross annual.
• Actual salaries may vary within the range based on several factors including 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.

Contact

For an immediate interview, please contact [email protected] .