We are seeking a Manager, Pharmacokinetic Lab. This role will act as a liaison between START US Sites and the pharmaceutical sponsors by providing information regarding collection, processing, handling, storage, and shipment of research and clinical laboratory samples to ensure successful execution of the protocol within the SOPs of the department. Provides oversight for lab operations, facilities, SOPs, and quality metrics.
Work Schedule: Monday-Friday 8:00am-5:00pm
Location:13400 SW 120th St, Miami, FL 33186
Essential Responsibilities:
- Oversee the processing of the samples by PK Lab Technicians and take appropriate corrective action to correct inconsistencies in collection data, as needed.
- Create standard operating procedures (SOPs) for the PK Department and Tumor Bank and perform an annual review and / or update. Oversee or delegate training of PK Department staff on all PK Department SOPs, at least annually, when new SOPs are written, and when any updates occur.
- Ensure compliance with all applicable Federal, State, and local laws and regulations as they apply to biological sample processing, handling, and shipping. Maintain accurate patient, study/protocol, and sponsor files.
- Perform hiring, training, and development of employees. Supervise all personnel and new hires.
- Oversee and complete study forms to include but not limited to: PK flowsheets, shipping logs, shipping documentation, sample requisition forms, flow sheets, and sample manifests.
- Track Site Initiation Visits, protocol amendments and lab manual updates.
- Participate in Protocol Development and Review Committee meetings by reviewing and providing comments for all phase 1 investigational protocols received by START.
Required Education and Experience:
- Bachelor's degree in a chemical, physical, biological, or clinical laboratory science or medical technology.
- At least five years laboratory setting experience.
- Quality management skills including personnel management, financial management and process management.
- Experience with electronic medical record program(s) and laboratory information systems.
Preferred Education and Experience:
- Prior experience in Phase I clinical trials.
- Knowledge of GCP, GDPR and federal clinical research regulations required in US.
- Experience in data management, logistics, and operations.
Best-in-Class Benefits and Perks
We value the time, talent, and dedication our employees bring to START. Our commitment to your well-being and growth is reflected in a competitive compensation package-based on experience-along with comprehensive benefits designed to support you both personally and professionally:
- 401(k) retirement savings plan with employer match
- Eligibility for an annual performance bonus, based on role and company results
- Generous paid time off and paid holidays
- Comprehensive medical, dental, and vision coverageand optional insuranceoptions
- Company p-aid life and disability insurance for added financial protection
- Employee Assistance Program (EAP) providing confidential, no -cost support for you and your family from day one
- Flexible FSA and HSA plans to support your financial wellness
- Commitment to a supportive environment that values balance, wellbeing, and flexibility
- We'recommitted to fostering a collaborative, creative workplace where every team member is encouraged to contribute. At START,you'lljoin a team that values continuous learning, professional growth, shared ideas, and a culture built on inclusivity and innovation.
