Precision Medicine Operations Lead – SKDL Programming Lead

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

📋 Description

• Collaborate in cross-functional study team meetings and workstreams that support the precision medicine strategy.

• Serve as a subject-matter expert on sample management and testing to assist clinical study teams.

• Anticipate potential challenges, manage project risks, and address queries from internal and external stakeholders.

• Develop and review sample-related sections of study documents, which include clinical protocols, informed consent forms (ICFs), and guidelines for sample management.

• Aid in the creation and validation of specialty laboratory databases for data collection and tracking of sample kits.

• Oversee the planning and execution of the biosample process, including aspects such as storage, shipping, and data transfer.

• Supervise the acquisition and testing of clinical trial samples for biomarker research.

• Evaluate biosample vendors, review proposals and bids, and clearly define the contractual scope.

• Forecast operational costs and timelines; manage budgeting, invoicing, and reporting tasks.

• Determine methods for capturing, blinding, transferring, and reporting biomarker data.

• Develop and review specifications for data transfer and related documentation.

• Guide and train clinical teams and investigative sites on the processes of biospecimen collection, storage, and shipment.

• Ensure that the transfer of human samples is documented, tracked, utilized, and destroyed in accordance with standard operating procedures (SOPs) and regulations.

• Manage clinical trial supplies, logistics, samples, kits, data operations, vendor management, and related processes as assigned.

• Oversee inventory of kits, sample collection and tracking, resolution of data queries, regulatory submissions, import/export documentation, proforma invoices, LIMS, and functional metrics.

• Create, implement, monitor, and enhance logistics strategies for clinical studies.

• Develop tools and dashboards for biomarker samples, kits, logistics, and laboratory data when serving as the programming lead.

• Aggregate, extract, process, and evaluate confidential data using various technical tools, systems, and programming languages.

• Assess laboratory databases, resolve queries related to biomarker data, and support activities related to database lock.

• Complete necessary training, timesheets, expense reports, and updates to your CV.

• Maintain effective working relationships across platforms, businesses, research, and enabling lines.

⛳️ Requirements

• A minimum of 6 years of clinical research experience within academia, Contract Research Organizations, or the pharmaceutical/biotech industry.

• Familiarity with the clinical drug development process and clinical databases.

• Understanding of ICH and GCP guidelines.

• Knowledge of US FDA and/or local country regulations as applicable.

• A Bachelor's degree in life sciences or an equivalent field (science, technology, engineering, or mathematics) or relevant work experience.

• A background in Biology or a related major is preferred.

• Proficient in speaking and writing English.

• Strong project management and organizational skills within a matrix environment.

• Experience in analytical and problem-solving tasks.

• Excellent written and verbal communication abilities.

• Effective communication and interpersonal skills, with a proven capacity to foster relationships both internally and externally.

• Proficiency in Microsoft Office applications, particularly strong knowledge of Excel.

• Familiarity with relevant role-specific systems.

• Proficient in programming languages such as Python, R, Perl, SQL, or others, along with knowledge of APIs and Linux/Unix environments, especially if taking on a programming lead role.

• Travel is not expected but may occur on occasion.

🏝️ Benefits

• Work from home in a home office setting.

• Opportunity for a balanced life outside of work.

• Eligibility for an annual performance-based bonus plan for qualifying roles.

• Annual salary review.

• Total rewards incentives for eligible positions.