Lead Clinical Programmer- FSP

Parexel; United States; Remote; USD 100,000 - 130,000; Full time

Job summary

A leading clinical research organization is seeking a Clinical Operations Lead to oversee clinical trial logistics and data management. Candidates should have extensive experience in clinical research and proficiency in programming languages like Python, R, and SQL. Responsibilities include establishing efficient processes, managing sample integrity, and leading cross-functional teams. This role requires excellent communication skills and the ability to navigate complex project challenges.

Qualifications

• 7+ years of experience in clinical operations preferred.
• 6+ years of clinical research experience in academic, CRO, or pharmaceutical/biotech settings.
• Proficiency in one or more programming languages like R, Python, Perl, SQL, MATLAB.

Responsibilities

• Establish and streamline processes to increase efficiency.
• Oversee operations ensuring integrity of database locks.
• Manage sample-related issues with labs and oversee communication with stakeholders.

Skills

Proficiency in Python

Proficiency in R

Project management

Strong problem-solving skills

Excellent communication skills

Education

Bachelor’s or master’s degree

Tools

Excel

Linux/Unix

Job description

PXL is seeking a clinical operations lead with expertise in clinical sample logistics and proficiency in computational programming to support the generation and delivery of quality biomarker samples and data.

Responsibilities will include one or more of the following: development of tools and dashboards for sample/data tracking, review of clinical sample collection, resolving sample/data queries, and support of database lock (DBL) activities. Proficiency in Python, R, MATLAB, and/or SQL programming is required.

The candidate will develop, drive, and handle clinical study related tasks for the team in collaboration with Precision Medicine Companion Diagnostics Operations, Laboratory Managers and Clinical Laboratory Study Management. Expertise in one or more of the following areas is required: samples, kits, data, and logistics operations for clinical trials. Understanding of one or more of the following is preferred: central labs, specialty testing labs, data operations, database development, LIMS, kit inventory management and sample tracking processes.

Job Responsibilities:

• Establish and streamline processes to increase efficiency and implement analytical tools to advance departmental goals.
• Oversee 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.
• Manage sample-related issues with central and specialty labs, acting as the primary point of contact for resolution.
• 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.
• Oversee and manage 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 projects.
• Enhance communication with senior stakeholders and align functions with group objectives.
• Participate in vendor oversight activities, including issue escalation, metrics reviews, and performance monitoring.

Job 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.
• 7+ years of experience in clinical operations preferred.

Education:

Bachelor’s or master’s degree.

Experience:

6+ years of clinical research experience in academic, CRO, or pharmaceutical/biotech settings, with knowledge of clinical trials and clinical databases.

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.