Act as the Client's main contact in all matters regarding central laboratory services, following up and responding to study specific inquiries from Sponsors, Physicians, CRA and CRO representatives and all internal Laboratory Departments.
As a Manager, the employee is expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
Manages the activities of the laboratory department within quality and budgetary guidelines. Ensures work in accordance of agreed turn-around time. Monitors and review proficiency testing, operational and department budget, laboratory quality control data, quality control systems and corrective actions. Conceive and implement continuous improvements and operational updates. Assists in developing and responsible for managing metrics related to all of the above.
Develop, implement and manage to performance standards for staff related to quality and efficiency, including productivity.
Manages the adherence to written internal and external quality control procedures in order to ensure the quality of the results. To evaluate means and standard deviations for quality control materials and maintain Corrective action logs as appropriate.
Responsible for the quality and timelines of technical procedures to ensure full compliance with CAP, relevant government regulations, GDP and other relevant standards as determined by the company Monitors reagents and supplies for section and assists in the performance of all related tasks for managing inventory.
Builds strong and effective teams, valuing different contributions; works with and through others, involving people in issues that affect them. Assist management in the recruitment and selection of staff.
Operates independently with a willingness to make decisions; Projects credibility and makes a professional and positive impression on others; Monitors progress and holds self and others accountable. Liaise with clients, vendors and staff on all department issues.
Maintains oversight of reagent and supply orders and approval of inventory purchases together with invoice coding. Assists the Corporate procurement team and negotiates pricing and service requirements with Vendor representatives in the best interest of ICON.
Effectively monitors laboratory operations in section and provides guidance to staff for all issues that arise including but not limited to, instrument failures, reagent/quality control issues, sample integrity issues, delays in testing and communication of abnormal result.
Identifies the key elements of a situation and any gaps and inconsistencies in data. Makes rational judgments from available information and analysis. Actively participates in root cause analysis investigations and process improvement initiatives. Responsible for timely and accurate responses-to Quality Issues assigned to them and/or their department.
Creates an environment that motivates people; Identifies development opportunities for self and others; Acts as a coach and mentor and shares expertise. Maintain a positive working environment ensuring staff motivation in particular periods of high workloads. Maintain low levels of staff turnover, actively contributing to the retention of key individuals.
Manages the evaluation of and validation of new methodologies and instrumentation works closely with Global Validations Department.
Works very closely with other departments, such as Project Management, LIS, Scientific Affairs, Global Validations, QA, Client Services and Global Labs. Also interacts with clients and internal/external auditors.
Manage the recruitment, training and development of staff in the various sections of the laboratory as required. Performs continuing education of laboratory staff in the various sections of the laboratory and sample management as required. Responsible for the evaluation of work performance of Technical laboratory staff in the section and for employee performance evaluations.
Review daily, weekly, and monthly metrics for assigned departments and implement as necessary staffing reallocation to ensure efficiency and quality.
Be aware of all pertinent employee health and safety regulations and requirements for their assigned department and manage compliance to same.
Approves purchase orders and all appropriate purchases for department area.
Covers for the Senior Manager/Director in the event of his or her absence.
Any other relevant tasks as assigned by management.
Hold a Bachelors' degree in Medical Technology or local equivalent or a BSc degree or local equivalent in Medical Laboratory Science/Biomedical Science majoring in Chemistry, Haematology, Immunology, and/or Infectious Diseases.
A postgraduate qualification such as FIBMS/FAMLS/ASCP or MSc while highly desirable is not essential.
You will possess a minimum of A minimum of 6 years' experience as a Technologist
A minimum of 6 years management experience
New York State- License as a Clinical Laboratory Technologist.
Compliance with all health and safety legislation and awareness of employee responsibilities in this context. Basic knowledge of immunization requirements for the role of occupational health professions.
Proficient and Compliant with all - CAP and local agency regulatory requirements.
Excellent knowledge of Microsoft Office.
Fluency in English both written and oral.
Demonstrated ability to manage multiple tasks with good organization skills and good attention to detail. Ability to work as part of, and set the example of performance standards for a team.
Ability to work in conformance with standard operating procedure and conditions with a systematic approach to tasks committed to seeing_ things through to completion.
Demonstrated ability to keep accurate, legible records and recognize the need to handle these records and all other information in line with GCP/GDP.
Familiar with the operation of laboratory equipment with a demonstrated ability to check that equipment is functioning within its specifications and to respond appropriately to abnormalities.
Demonstrates the ability to understand the principles of quality control, quality assurance. Knowledge of the role of audit and review in quality management, including quality control, quality assurance and the use of appropriate outcome measures.
Demonstrates patience and knowledge of laboratory operations to act as a mentor to section team, identifying and developing each person's unique talent with a view to achieving department/company objectives.
Customer Focused - providing timely, confident, reliable and friendly service to all our internal and external customers and inspiring the team to follow your example.
Demonstrates a high level of personal integrity and ethical behavior with a responsible and mature approach to work duties. A willingness to lead from the front and inspire by example.
Action oriented demonstrating the ability to handle work load demands resulting in the generation of large amounts of data and to trouble shoot issues timely when required.
Demonstrates the ability to manage budgets and productivity metrics to ensure department area meets financial goals.
Creative and enthusiastic with the ability to suggest and assists in implementing process improvement initiatives.
Ability to confidentially interact with all levels in the organization and provide senior management with valued feedback,
Courage to make tough decisions and perseverance to see projects through to completion
Basic working knowledge of LIMS with the desire to achieve mathematical computational, and instrumentation skills necessary to work and progress Biomedical Science.
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