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.
