Senior Clinical Programming Lead

2 days ago

Augusta, ME, United States PAREXEL Full time

PXL is on the lookout for a Senior Clinical Programming Lead with extensive experience in clinical sample logistics and a strong background in computational programming. This role is integral to ensuring the delivery of high-quality biomarker samples and data.

The key responsibilities of this position include:

  • Developing innovative tools and dashboards for effective sample and data tracking.
  • Reviewing clinical sample collection processes to ensure compliance and quality.
  • Resolving complex sample and data queries while supporting database lock (DBL) activities.
  • Collaborating with Precision Medicine Companion Diagnostics Operations, Laboratory Managers, and Clinical Laboratory Study Management on clinical study tasks.

To succeed in this role, you will need:

  • Proficiency in programming languages such as Python, R, MATLAB, and SQL.
  • Experience in clinical trials focusing on samples, kits, data, and logistics operations.
  • A preference for familiarity with central labs, specialty testing labs, data operations, and inventory management systems.

Your responsibilities will include:

  1. Establishing and optimizing processes to boost efficiency and implementing analytical tools aimed at achieving departmental goals.
  2. Managing sample and data operations to ensure data integrity and readiness for database locks.
  3. Utilizing technical tools and programming languages to clean and manage confidential data according to established guidelines.
  4. Aggregating and extracting essential operational report information programmatically.
  5. Mapping structured data and performing data management tasks effectively.
  6. Ensuring compliance with informed consent forms (ICFs) related to sample handling, tracking, usage, and disposal.
  7. Acting as the main point of contact for resolving sample-related issues with central and specialty labs.
  8. Maintaining metrics on clinical study samples, data, kits, and logistics for performance assessment.
  9. Leading cross-functional study teams, vendor relationships, and overseeing clinical trial biosamples and data integrity.
  10. Proactively managing challenges, dependencies, and risks across projects to ensure smooth execution.
  11. Enhancing communication with senior stakeholders and aligning strategies with group objectives.
  12. Participating in vendor oversight activities, including performance reviews and issue escalation.

Job Requirements:

  • Strong proficiency in programming languages (R, Python, Perl, SQL, MATLAB).
  • Familiarity with APIs and experience in database and dashboard development, preferably in Linux/Unix environments.
  • Capability to analyze sample interdependencies critically and plan for potential risks and issues that impact clinical studies/programs.
  • Exceptional problem-solving, project management, and organizational skills with the ability to prioritize and multi-task effectively.
  • Proven experience in process development and project management, including vendor management.
  • Excellent communication and presentation skills, both written and oral.
  • Advanced Excel proficiency.
  • Over 7 years of experience in clinical operations preferred.

Education:

Bachelor's or master's degree in a relevant field.

Experience:

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

#LI-REMOTE

EEO Disclaimer:

Parexel is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

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