Lab Manager Jobs

About The Position

Requirements

• 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.
• Strong interpersonal skills to lead effective teams, resolve conflict, solve problems and communicate in a fast-paced work environment.
• General knowledge of medical terminology.
• High attention to detail and strong organizational skills.
• Ability to work well independently.
• Organizational skills to troubleshoot unplanned situations while still meeting established deadlines.
• Microsoft office suite AND ability to learn new software.
• Use of electronic medical record program(s) and laboratory information systems.
• Must maintain punctuality, good attendance and be flexible to work hours to accommodate clinic patient schedule.

Nice To Haves

• Prior experience in Phase I clinical trials.
• Knowledge of GCP, GDPR and federal clinical research regulations required in US.
• Experience in data management.
• Experience in logistics and operations.

Responsibilities

• 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.
• Develop employment protocols including employee job descriptions, goals, performance standards, employee performance evaluations and counsel staff on job performance as needed.
• Design and encourage an efficient and quality environment for the PK Department and Tumor Bank.
• Work with START Directors and Managers to ensure quality clinical trials operations.
• Coordinate technician work schedules to include day, night, and weekend coverage.
• 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.
• Oversee the processing of the samples by PK technicians and take appropriate corrective action to correct inconsistencies in collection data and take appropriate corrective action as needed.
• Contact the nurse immediately to have the situation corrected before the patient leaves the building.
• 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.
• Assist technicians in maintaining adequate documentation, records, and interactions with study personnel.
• 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.
• Oversee study specific and departmental inventory control and re-supply of reagents and supplies as needed.
• Ensure maintenance of distribution lists for PK correspondence of sponsors and monitors for each trial.
• Oversee maintenance, certifications, and calibrations of equipment as applicable.
• Oversee cleaning and sanitation of laboratory and equipment.
• Oversee management of electronic temperature monitoring system and response to warnings and alarms.
• Participate in on-call rotation for emergency management.
• Performs monthly administrative functions within the PK Department and Tumor Bank, to include: Statistical counts of the samples for documentation and billing.
• Review of monthly statements for consistency and correctness before turning over to accounting department.
• Scanning of department and study documents for documentation and billing.
• Contribute to preparation of annual department budget as requested.

Benefits

• 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 coverage and optional insurance options
• Company paid 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