Manager, Pharmacokinetic Lab
About The Position
The Manager, Pharmacokinetic Lab serves as a liaison between START US Sites and pharmaceutical sponsors, providing information on the collection, processing, handling, storage, and shipment of research and clinical laboratory samples. The role helps ensure protocol execution in accordance with departmental SOPs and oversees laboratory operations, facilities, SOPs, and quality metrics. The manager supervises laboratory personnel and sample processing, ensures compliance with applicable regulations, maintains study and sponsor records, and oversees study documentation. The role also develops and maintains departmental SOPs, trains staff, tracks site and protocol updates, and participates in the review of Phase I investigational protocols. The position is scheduled Monday through Friday, 8:00 a.m. to 5:00 p.m., at 4383 Medical Dr, San Antonio, Texas.
Requirements
- Bachelor’s degree in chemical, physical, biological, or clinical laboratory science, or medical technology.
- At least five years of experience in a laboratory setting.
- Quality management skills, including personnel management, financial management, and process management.
- Experience with electronic medical record programs and laboratory information systems.
Nice To Haves
- Prior experience in Phase I clinical trials.
- Knowledge of GCP, GDPR, and federal clinical research regulations in the United States.
- Experience in data management, logistics, and operations.
Responsibilities
- Oversee sample processing by PK Lab Technicians and take appropriate corrective action to address inconsistencies in collection data.
- Create SOPs for the PK Department and Tumor Bank, and review or update them annually.
- Oversee or delegate staff training on PK Department SOPs at least annually, when new SOPs are written, and when updates occur.
- Ensure compliance with applicable federal, state, and local laws and regulations governing biological sample processing, handling, and shipping.
- Maintain accurate patient, study/protocol, and sponsor files.
- Hire, train, and develop employees; supervise all personnel and new hires.
- Oversee and complete study forms, including PK flowsheets, shipping logs and documentation, sample requisition forms, flow sheets, and sample manifests.
- Track Site Initiation Visits, protocol amendments, and laboratory manual updates.
- Participate in Protocol Development and Review Committee meetings by reviewing and commenting on Phase I investigational protocols received by START.
Benefits
- 401(k) retirement savings plan with employer match.
- Eligibility for an annual performance bonus, based on role and company results.
- Paid time off and paid holidays.
- Medical, dental, and vision coverage, with optional insurance options.
- Company-paid life and disability insurance.
- Employee Assistance Program providing confidential, no-cost support for employees and their families from day one.
- Flexible FSA and HSA plans.
- A supportive environment that values balance, wellbeing, and flexibility.
- Collaborative workplace with opportunities for continuous learning and professional growth.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
