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.