Improve regional lab operation productivity (Revenue/FTE), assays unit costs, re-organize workflows and platforms (consolidate, concentrate) to maximize profits (contribution margin) and quality (volume/bench).
Collaborate with the Global Business Process Owners and staff members of Investigator Services, Project Management, Data Management, IT and Quality Assurance to deliver high quality Laboratory services within required turnaround time and improved operating performance (efficiency, quality, speed, cost and competitiveness).
Assist in developing new laboratory services and processes to exceed sponsors\' expectations, deploy new assays on time and Key Accountabilities
Control regional operation for compliance with the company\'s global and unique set of quality standards (GxP, CAP, ISO, etc.). Assist in the roll out of new and improved programs. Secure and maintain accreditations recognized by sponsors (CAP, NGSP, etc.).
Support and work with QA: ensure timely resolution of corrective actions to clients\' and internal audit findings. Implement and follow through preventive actions - amend SOPs, document staff competency and controls staff compliance.
Ensure analytical QC and proficiency testing programs are performed and corrective actions taken within set time frames.
Collaborates with subcontracting partner laboratories, external network of laboratory scientists and medical experts, vendors and suppliers supporting laboratory operations and services to maintain/improve service level, ensuring client satisfaction.
Manage staff performance: set objectives in line with annual plan, perform regular reviews, manage deviations, provide rewards or corrective measures as requested, manage TCE budget within guidelines. Recruit, train and retain highest caliber individuals that meet the requirements for performing the job. Manage poor performers. Ensure on going staff competency in their respective roles
Requirements
Five (5) years required in (central) clinical lab operations in large hospital setting or CRO/lab services industry.
Two (2) years required in managing clinical lab operations (additional experience in managing microbiology and molecular biology preferred).
Two (2) years in managing personnel.
Demonstrated experience with CAP and/or ISO requirements.
Proficient use of enterprise-grade LIMS and Microsoft Office
Suite.Bachelor\'s degree required, Master\'s degree (preferred) in clinical (bio) chemistry or related discipline.