Location: San Antonio, Texas, United States
Requisition Number: 1797
Position Title: Senior Manager, Clinical Laboratory
SUMMARY: The Clinical Laboratory Senior Manager is responsible for the implementation and conversion of a moderate-complex lab to a high-complexity laboratory operation. You will have an established background in CLIA lab operations, people management, and lab leadership.
Tasks may include but are not limited to:
- Oversees the laboratory quality assurance program to include specimen collection, handling, and reporting, quality control and documentation review, and proficiency testing.
- Ensures quality laboratory services for pre-analytic, analytic, and post-analytic phases of testing
- Hires provides training for and evaluates the necessary qualified laboratory staff to adequately perform general and protocol-specific lab procedures.
- Schedules laboratory staffing.
- Complies with CLIA guidelines and regulations for laboratory accreditation and certifications.
- Ensures laboratory facilities are adequate for safe and accurate testing.
- Establishes and enforces safety policies and procedures.
- Researches, acquires, and implements procedures for laboratory equipment as required per protocol
- Ensures quality, accurate and reliable test results.
- Ensures remedial actions are taken and documented when necessary.
- Supervises directs and monitors the performance of laboratory technologists and technicians. Must be accessible to the laboratory to provide onsite, telephone or electronic consultation as needed.
- Participates in Sponsor audits and site visits, as applicable.
- Writes reviews and updates Clinical Laboratory Procedure Manual(s).
- Orders and maintains inventory of laboratory and medical supplies.
- Reviews quality control and maintenance reports on a regular basis.
- Carries out reasonable directives from the Laboratory Director or Principle Investigator.
- Responsible for requesting, scheduling, and attending any training required for this position.
- Establishes quality measures and looks for ways to improve efficiencies and cost controls.
- Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
OTHER SKILLS AND ABILITIES:
- Strong interpersonal and communication skills; excellent attention to detail; exceptional organizational and planning skills. Able to project and coordinate clinic needs in advance. Needs to have very good troubleshooting and conflict resolution skills.
- In-depth knowledge of the clinical research process, including Good Clinical Practices and ICH guidelines; ability to make good, sound decisions under stress and with time restraints; ability to forecast potential problems in multiple departments.
- Possible equipment includes, but is not limited to: computers, rolling carts, fax machine, photocopier, telephone, lab apparatus, mop/broom, needles, centrifuges, scales, calculators, and microscopes.
Required: Bachelor of Science degree with certification as a Medical Technologist or equivalent.
Preferred: Bachelor’s Degree (preferably in the field of Life Sciences or Health), at least 3-4 years of Phase I experience; at least 3- 4 years of supervisory experience.
- The Clinical Laboratory Senior Manager directly supervises Full-Time Medical Technologists/Medical Laboratory Scientists, Full-Time Medical Laboratory Technicians, PRN Medical Technologists/Medical Laboratory Scientists, and PRN Medical Laboratory Technicians.
- The Clinical Laboratory Senior Manager is responsible for planning, staffing, and performing any needs for clinical trials within the Clinical Laboratory. He/she is responsible for ensuring all staff within the Clinical Laboratory are trained, equipment is calibrated, and all data is reported with accuracy and efficiency.
- The Clinical Laboratory Senior Manager will have a large amount of contact with staff, equipment, supply vendors, and a small amount of contact with clients. Professionalism will be of the utmost importance as a representative of WCT.
- Possible mental demands include, but are not limited to: reading, math, writing, intense concentration, verbal communication, written communication, client contact, and attention to detail, multiple tasks, frequent interruptions, fluctuation in workload.
- Possible physical demands include but are not limited to lifting and carrying of objects weighing 5-50 lbs., hearing, seeing, gross and fine motor use of upper extremities, kneeling, walking, standing, leaning over for extended periods of time, squatting, eye strain/fatigue, climbing, pushing, pulling, reaching, and exposure risk to potentially infectious blood and/or body fluids, and/or hazardous fumes or chemicals.
Employment Type: Regular
Community / Marketing Title: Laboratory Manager
We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.
Location_formattedLocationLong: San Antonio, Texas US
CountryEEOText_Description: Worldwide Clinical Trials is an equal opportunity employer, dedicated to a policy of non-discrimination in employment on any basis including age, sex, color, race, creed, national origin, religion, marital status, sexual orientation, political belief or disability.