Role Overview The
Associate Sampling Oversight Manager is responsible for overseeing the complete lifecycle of clinical trial samples, including collection, tracking, analysis, reporting, and destruction, while ensuring compliance with protocols and regulations. The position serves as the primary contact for trial teams, managing lab operations, reconciliations, and queries, while collaborating cross-functionally to define testing requirements, maintain sample logs, and develop processes, SOPs, and training materials.
Reports to: Sr. Manager, Team Lead Sample Oversight
Location: Remote
Salary Range: $95,000 to $130,000
Basic Qualifications: - Bachelor's degree in pharmaceutical sciences, life sciences, bioengineering, or a related field
- 4+ years sample management in the pharmaceutical/ biotechnology industry
Preferred Qualifications: - 2+ years of project management experience in the pharmaceutical/ biotechnology industry, preferred in laboratory related functional area
- Demonstrated experience in laboratory related functional area within the GCP/GCLP/GLP area
- Strong knowledge of ICH-GCP, FDA, EMA, and applicable clinical trial regulations
- Proficiency with clinical trial systems and tools (e.g., CTMS, eTMF, Microsoft Office)
In this role you will: - Track of all clinical trial samples from sample collection until destruction, including clinical trial samples at external clinical trial testing labs
- Ensure the maintenance of a global clinical trial sample log and track the sample status
- Query management for clinical trial samples at internal clinical trial testing labs
- Perform lab reconciliation in collaboration with internal clinical trial testing labs and Clinical Data Manager
- Oversight of operational activities throughout the clinical trials related to clinical trial samples within internal clinical trial testing labs including sampling, storage, transfer, analysis, reporting, current challenges, workload, risks, issues
- Oversight of operational close-out activities related to internal clinical trial sampling and analyses
- Collaborate with internal and external Functional Leads (i.e. Clinical Operations Lead, Correlative Studies Lead, Translational Lead, any Sample Owner, etc) to define clinical trial specific clinical testing requirements (e.g. sample collection timepoints, sample type and volume, sample labelling, analysis method, sample shipment, storage and destruction)
- Support Clinical Outsourcing Manager and Clinical Operations Lead for external central laboratory selection
- Partner with internal Functional Leads (e.g. Clinical Operations, Immatics Laboratory groups, Correlative Studies Lead, Sample Logistics, Clinical Data Manager) to agree on internal and external clinical trial testing labs, analysis frequency and result reporting
What do we offer? At Immatics, we believe in investing in our team's health, safety and well-being. Here's what you can expect if you join Immatics
Comprehensive Benefits:
- Competitive rates for Health, Dental, and Vision Insurance
- 4 weeks of vacation, granted up front each year and prorated for first and last year of employment.
- 12 company paid holidays
- 7 days of sick time
- 100% employer-paid life insurance up to at 1x annual salary, up to one hundred thousand dollars
- 100% employer-paid short- and long-Term disability coverage
- 401(k) with immediate eligibility and company match. The company will match 100% of your contributions up to 3% of your base salary for the first two years of employment, 4% for years 2-3 of employment, and up to 5% of your salary from the fourth year onward of continued employment.
- 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.
