To deliver standardized clinical trials laboratory services at the highest operating and financial performance. To ensure superior, analytical performance that exceeds global bio-pharmaceutical sponsors’ expectations (i.e. turnaround time, long-term results ‘consistency within set specifications, lower unit cost). To provide accurate and timely services to investigators to safeguard study subjects’ safety and protocol compliance. The incumbent leads a regional laboratory operation and streamlines current, or develops new, profitable analytical services.
Key Accountabilities:
- 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.
