Job Description

　　Manages a team within the Laboratory department. Processes and ships study specimens according to study protocol. Oversees department compliance with organizational policies and procedures, as well as Good Clinical Practice/ICH, GDP, OSHA and CIA or CLIA-waived guidelines and local regulatory guidelines. Ensures the business continuity of the department.

　　Essential Functions

　　Manages staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime.Forecasts and manages all functions of the early phase clinical and PK Laboratory. Contributes to the development and maintenance of procedures and policies to support optimization of operations.Projects staffing requirements. Assures that the training needs and requirements of laboratory are met.Arranges and projects the activities, methods and procedures of the sample collection to ensure proper specimen integrity and shipping are successfully attained.Plans the development, implementation and continuous monitoring of a quality improvement plan for the group.

　　Qualifications - External

　　Education and Experience:

　　Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years) or equivalent and relevant combination of education, training, & experience.1+ year of leadership responsibility

　　In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

　　Knowledge, Skills and Abilities:

　　Good knowledge of CLIA, CAP and FDA regulationsStrong leadership skills, including ability to motivate, mentor and trainAdvanced written and verbal communication skillsStrong time management, organizational and multi-tasking skillsSolid critical thinking, problem-solving and troubleshooting skillsProficient in Microsoft Office productsAbility to work in a collaborative team environmentStrong knowledge of operational laboratory instrumentationGood knowledge of special handling and processing of specimensAdvanced knowledge of operating laboratory instrumentationGood understanding of budgeting and forecasting with the ability to interpret data with attention to detail and analytical and investigative skillsCapable of driving innovation in developing new ideas related to process improvements

　　Working Environment:

　　PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

　　Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.Able to work upright and stationary and/or standing for typical working hours.Able to lift and move objects up to 25 poundsAble to work in non-traditional work environments.Able to use and learn standard office equipment and technology with proficiency.May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.