Programming Lead (Samples, Kits, Data & Logistics) - FSP - Remote - Ireland

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.

We are seeking an experienced Programming Lead, Samples, Kits and Laboratory to support precision medicine initiatives across global clinical development programs. This role serves as a key technical and operational partner, driving the management, oversight, and optimization of biomarker samples, laboratory operations, kit logistics, and associated data throughout the clinical trial lifecycle.

Working cross-functionally with clinical study teams, data management, biostatistics, laboratory vendors, and operational stakeholders, you will play a critical role in ensuring high-quality sample management, laboratory data integrity, and operational excellence. Your expertise will help advance precision medicine strategies that support the development of innovative therapies for patients worldwide.

Key Responsibilities

• Participate in cross-functional study teams to support and deliver precision medicine strategies across assigned clinical studies.
• Serve as a subject matter expert for technical and operational aspects of sample management, testing activities, and biomarker-related study operations.
• Lead the planning, tracking, and oversight of biomarker samples, kits, laboratory operations, logistics, and associated data throughout the study lifecycle.
• Develop tools and dashboards that support tracking of samples, kits, laboratory data, and operational metrics within precision medicine programs.
• Use programming tools and technologies to aggregate, extract, process, and assess study data in accordance with industry standards and study requirements.
• Support the development and review of sample-related content for study documents, including protocols, informed consent forms, and sample management guidelines.
• Collaborate with data management and biostatistics teams to define biomarker data capture, transfer, reporting, and database requirements.
• Review laboratory databases, resolve biomarker data queries, and support database lock activities to ensure data quality and compliance.
• Manage operational activities related to biosample storage, shipping, testing, data transfers, budgeting, reporting, and vendor oversight.
• Help ensure human sample management processes meet protocol requirements, standard operating procedures, and applicable regulatory standards.

Candidate Profile

You’ll thrive in this role if you bring:

• Strong project management, organizational, and analytical problem-solving capabilities within a matrix environment.
• Experience working in clinical research, biotechnology, pharmaceutical, academic, or Contract Research Organization environments.
• The ability to build productive partnerships across multidisciplinary teams and communicate effectively with internal and external stakeholders.
• A quality-focused approach with strong attention to detail and commitment to advancing clinical research outcomes.
• Comfort working with laboratory databases, biomarker data, sample management processes, and role-specific technology platforms.

Required Qualifications

• Bachelor's degree in Life Sciences or equivalent discipline such as Science, Technology, Engineering, or Mathematics, or relevant work experience. Biology or a related major preferred.
• Minimum of 6 years of clinical research experience within an academic institution, Contract Research Organization, pharmaceutical company, or biotechnology organization.
• Working knowledge of clinical drug development, clinical databases, ICH-GCP guidelines, and applicable regulatory requirements including FDA and local country regulations as appropriate.
• Proficiency with Microsoft Office applications, including strong Excel capabilities, and relevant role-specific systems.
• Strong written and verbal communication, organizational, and problem-solving skills.
• Proficiency in Python, R, Perl, SQL, or other programming languages, together with familiarity with APIs and Linux/Unix environments.
• Fluent English language skills, both written and verbal.

Preferred Qualifications

• Degree concentration in Biology or a related life sciences discipline.
• Experience supporting precision medicine, biomarker operations, laboratory data management, or biosample logistics within clinical trials.
• Familiarity with laboratory information management systems (LIMS), specialty laboratory databases, and clinical data transfer processes.
• Experience working with global clinical study teams, specialty vendors, and laboratory operations across multiple studies.

Benefits and Compensation

• Health, Vision & Dental Insurance
• Vacation/Holiday/Sick Time
• Flexible benefit portal
• Car or car allowance (only applicable roles)

If this job does not sound like the next step in your career, but you know someone who would be a great fit, please share the application link with them.

We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research and help bring innovative treatments to patients around the world.