Precision Medicine Operations Lead – SKDL Programming Lead

This is a fully remote position, open to applicants in Poland.

📋 Description

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

• Act as a subject-matter expert on sample management and testing, providing support to clinical study teams.

• Create and evaluate sample-related components of clinical protocols, informed consent documents, and sample management guidelines.

• Assist in the development and validation of specialized laboratory databases for data collection and tracking of sample kits.

• Oversee the planning and execution of the biosample process, which includes storage, shipping, and data transfer.

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

• Evaluate biosample vendors, assess proposals and bids, and outline the contractual scope of work.

• Anticipate operational costs and timelines; manage budgeting, invoicing, and reporting activities.

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

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

• Offer guidance and training regarding biospecimen collection, storage, and shipment procedures.

• Ensure that human sample transfers are documented, monitored, utilized, and disposed of in accordance with SOPs and regulations.

• Manage clinical trial supplies, logistics, kits, samples, data operations, vendors, and function-specific performance metrics.

• Support logistics strategies for precision medicine and assess new technologies and vendors.

• Create tools and dashboards for tracking biomarker samples, kits, logistics, and laboratory data.

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

• Review laboratory databases, address biomarker data inquiries, and support database locking activities.

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

• Foster effective relationships across various platform lines, business/research units, and enabling lines.

⛳️ Requirements

• At least 6 years of experience in clinical research within academic, Contract Research Organizations, pharmaceuticals, or the 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 regulations as applicable.

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

• Proficiency in both spoken and written English.

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

• Experience in analytical thinking and problem-solving.

• Excellent communication skills, both written and verbal.

• Strong interpersonal skills and the ability to build effective relationships.

• Proficient in Microsoft Office applications, especially with advanced knowledge of Excel.

• Proficient in Python, R, Perl, SQL, or other programming languages, APIs, and Linux/Unix environments if serving as the programming lead.

• Travel is not anticipated but may occur on occasion.

🏝️ Benefits

• Flexibility to work from a home office.

• Long-term career opportunities and job stability.

• Time allocated for personal life outside of work.

• Annual performance-based bonus plan for qualifying positions.

• Annual salary review for eligible roles.

• Total rewards incentives for qualifying positions.