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.
Bachelor's degree in life sciences or equivalent; 6+ years clinical research experience; knowledge of ICH-GCP and regulatory requirements; proficiency in Microsoft Office, Python, R, Perl, SQL, APIs, Linux/Unix; fluent English.
Key Responsibilities
- managing sample operations
- developing tracking tools
- collaborating with study teams
Skills & Tools
Microsoft Office, Microsoft Excel, Python, R, Perl, SQL, APIs, Linux, Unix, LIMS
Job Details
- Category: Data and Analytics
- Seniority: Senior Level
- Commitment: Full Time
- Workplace: Remote — Ireland
- Languages: English
Benefits
- Generous paid time off
About Parexel
A clinical research organization supporting global drug development and precision medicine initiatives. — Industry: Research and Development