Laboratory Operations Programming Lead - FSP

Parexel is seeking an operations lead with expertise in lab operations and proficiency in computational programming to support the generation and delivery of quality biomarker samples and data, contributing to clinical development solutions that benefit patients.

Location: United States

Responsibilities

• Establish and streamline SKDL processes to increase efficiency and implement analytical tools to advance departmental goals.
• Support SKDL operations, including samples, kits, and data processes, ensuring integrity and completeness for database locks.
• Use technical tools/systems and programming languages to systematically clean data, including processing confidential data according to guidelines.
• Programmatically aggregate and extract key information from operational reports.
• Possess knowledge of structured data, such as entities, classes, hierarchies, relationships, and metadata, with the ability to perform data mapping.
• Support processing of informed consent forms (ICFs) and ensure compliance with ICFs for internal sample handling, tracking, usage, and destruction.
• Maintain and review metrics related to clinical study samples, data, kits, and logistics.
• Lead cross-functional study teams, manage vendor relationships, and oversee clinical trial biosamples and data monitoring.
• Support clinical trial biosamples and data monitoring and completeness from collection through to disposal, per requirements of the study.
• Anticipate challenges, manage dependencies, and mitigate risks across SKDL projects.
• Enhance communication with senior stakeholders and align SKDL functions with group objectives.
• Participate in vendor oversight activities, including issue escalation, metrics reviews, and performance monitoring.

Requirements

• Proficiency in one or more programming languages (R, Python, Perl, SQL, MATLAB)
• Familiarity with APIs, database development, dashboard development, and Linux/Unix environments
• Ability to critically analyze and plan for sample interdependencies, risks, and issues with an awareness of the impacts to clinical studies/program.
• Strong problem-solving, project management, and organizational skills, with ability to effectively multi-task and prioritize.
• Extensive process development and project management experience including vendor management
• Excellent oral and written communication and presentation skills
• Advanced excel knowledge required
• 6-7 years of experience in lab operations and programming preferred.

Additional Information

• Bachelor’s or master’s degree.
• 6+ years of clinical research experience in academic, CRO, or pharmaceutical/biotech settings, with knowledge of clinical trials and clinical databases.