Associate Sampling Oversight Manager

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

📋 Description

• Oversee the entire lifecycle of clinical trial samples, encompassing collection, tracking, analysis, reporting, and disposal.

• Act as the main contact point for trial teams.

• Manage laboratory operations, reconciliations, and inquiries.

• Collaborate across functions to establish testing requirements.

• Maintain sample logs and monitor sample status.

• Create processes, standard operating procedures (SOPs), and training materials.

• Monitor clinical trial samples from collection to destruction, including those at external testing laboratories.

• Address inquiries regarding clinical trial samples at internal testing facilities.

• Conduct lab reconciliations with internal testing labs and the Clinical Data Manager.

• Supervise operational activities related to clinical trial samples within internal testing labs, which include sampling, storage, transfer, analysis, reporting, challenges, workload management, risks, and issues.

• Manage operational close-out activities concerning internal clinical trial sampling and analyses.

• Collaborate with both internal and external Functional Leads to determine clinical trial-specific testing needs.

• Assist the Clinical Outsourcing Manager and Clinical Operations Lead in selecting external central laboratories.

• Work with internal Functional Leads to reach agreements on internal and external testing labs, analysis frequency, and result reporting.

⛳️ Requirements

• Bachelor’s degree in pharmaceutical sciences, life sciences, bioengineering, or a related discipline.

• Over 4 years of experience in sample management within the pharmaceutical or biotechnology sector.

• At least 2 years of project management experience in the pharmaceutical or biotechnology industry, preferably in a laboratory-related functional area.

• Proven experience in a laboratory-related functional area within the GCP/GCLP/GLP framework.

• Strong understanding of ICH-GCP, FDA, EMA, and relevant clinical trial regulations.

• Proficient in clinical trial systems and tools (e.g., CTMS, eTMF, Microsoft Office).

• Candidates must be authorized to work in the United States without the need for current or future sponsorship.

• Successful completion of a background check, reference checks, and pre-employment drug screening, where permissible by applicable law.

• For specific roles, additional screenings such as a credit check or motor vehicle record review may be necessary, provided they are job-related and consistent with business necessity.

🏝️ Benefits

• Competitive rates for Health, Dental, and Vision Insurance.

• Four weeks of vacation, granted upfront each year and prorated for the first and last year of employment.

• Twelve company-paid holidays.

• Seven days of sick leave.

• 100% employer-paid life insurance up to one times the annual salary, capped at one hundred thousand dollars.

• 100% employer-paid short- and long-term disability coverage.

• 401(k) with immediate eligibility and company matching.

• Partially paid parental leave for eligible employees.

• Additional voluntary employee-paid benefits and services, including accident, hospital indemnity, and critical illness insurance, as well as identity theft protection and pet insurance.