Precision Medicine Operations Lead – SKDL Programming Lead

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

📋 Description

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

• Offer expertise in sample management and testing, proactively identify challenges, manage project risks, and address stakeholder inquiries.

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

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

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

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

• Evaluate biosample vendors, analyze proposals and bids, and establish the contractual scope.

• Project operational costs and timelines; handle budgeting, invoicing, and reporting duties.

• Collaborate with data management and biostatistics teams on biomarker data capture, blinding, transfer, and reporting activities.

• Develop and assess data transfer specifications and associated documentation.

• Provide guidance and training to clinical teams and investigative sites on compliance with biospecimen collection, storage, and shipping protocols.

• Ensure that human sample transfers are documented, tracked, utilized, and disposed of in accordance with SOPs and regulatory standards.

• Manage logistics and supplies for clinical trials, including samples, kits, data operations, and vendor management.

• Supervise kit inventories, sample collection and tracking, data query resolution, regulatory submission documents, import/export documentation, proforma invoices, LIMS, and performance metrics.

• Assist in the creation, implementation, monitoring, and enhancement of logistics strategies for clinical studies.

• Develop tools and dashboards for monitoring biomarker samples, kits, logistics, and laboratory data.

• Utilize technical tools, systems, and programming languages to aggregate, extract, process, and evaluate data.

• Review laboratory databases, resolve biomarker data inquiries, and facilitate database lock processes.

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

• Foster effective relationships across platforms, businesses, research, and enabling functions.

⛳️ Requirements

• At least 6 years of clinical research experience in an academic, Contract Research Organization, pharmaceutical, or biotech setting.

• Proficient understanding of the clinical drug development process and clinical databases.

• Familiarity with ICH, GCP guidelines, and US FDA and/or relevant local regulations.

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

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

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

• Experience in analytical thinking and problem-solving.

• Excellent written and verbal communication capabilities.

• Strong communication and interpersonal skills, with a proven track record of building internal and external relationships.

• Proficient in spoken and written English.

• Competent in Microsoft Office applications, particularly with advanced Excel skills, and relevant role-specific systems.

• Proficient in programming languages such as Python, R, Perl, SQL, or others, with familiarity in APIs and Linux/Unix environments, especially if serving as the programming lead for supplies and laboratory operations.

• Travel is not anticipated but may occur on occasion.

🏝️ Benefits

• Opportunity to work from a home office.

• Long-term employment prospects and job stability.

• Flexibility to maintain a work-life balance.

• Professional challenges and opportunities to contribute to clinical development.