Programming Lead – FSP

This is a fully remote position, open to applicants in United Kingdom, +1 more country.

📋 Description

• Engage in cross-functional study teams to facilitate and implement precision medicine strategies across designated clinical studies.

• Act as a subject matter expert on the technical and operational facets of sample management, testing activities, and biomarker-related study functions.

• Oversee the planning, tracking, and management of biomarker samples, kits, laboratory operations, logistics, and related data throughout the study lifecycle.

• Create tools and dashboards to assist in tracking samples, kits, laboratory data, and operational metrics.

• Utilize programming tools and technologies to aggregate, extract, process, and evaluate study data in compliance with industry standards and study specifications.

• Assist in the development and review of sample-related content for protocols, informed consent documents, and sample management guidelines.

• Collaborate with data management and biostatistics teams to establish biomarker data capture, transfer, reporting, and database specifications.

• Examine laboratory databases, address biomarker data inquiries, and support database lock procedures.

• Oversee biosample storage, shipping, testing, data transfers, budgeting, reporting, and vendor management.

• Ensure that human sample management processes adhere to protocol requirements, SOPs, and relevant regulatory standards.

⛳️ Requirements

• Bachelor's degree in Life Sciences or a related field such as Science, Technology, Engineering, or Mathematics, or equivalent professional experience.

• At least 6 years of clinical research experience in an academic institution, Contract Research Organization, pharmaceutical company, or biotechnology organization.

• Familiarity with clinical drug development, clinical databases, ICH-GCP guidelines, and relevant regulatory requirements, including FDA and local regulations as applicable.

• Proficient in Microsoft Office applications, particularly Excel, along with other role-specific systems.

• Excellent written and verbal communication skills, along with strong organizational and problem-solving abilities.

• Skilled in Python, R, Perl, SQL, or other programming languages, with an understanding of APIs and Linux/Unix environments.

• Fluent in English, both written and spoken.

• Experience in clinical research, biotechnology, pharmaceutical, academic, or Contract Research Organization settings.

• Ability to foster productive relationships across multidisciplinary teams and communicate effectively with both internal and external stakeholders.

• Comfortable working with laboratory databases, biomarker data, sample management processes, and technology platforms relevant to the role.

🏝️ Benefits

• Health, Vision & Dental Insurance

• Vacation/Holiday/Sick Time

• Flexible benefit portal

• Car or car allowance (applicable for specific roles)