Senior Manager, Performance Testing & Clinical Evaluations 9/16/2017
Beckman Coulter, Inc.
JOB DESCRIPTIONAPPLY The senior manager of the Performance Testing and Clinical Evaluations provides strategic direction and leads the development and execution of system performance testing, including clinical studies, through the entire product life cycle. Such studies include system performance testing in various prototype phases, product design verification and validation studies, clinical studies in support of regulatory submissions, benchmarking studies against competitive production offerings, product evaluations and any other studies or special assignments.
Provides verification and validation (V&V), and clinical expertise to the research and development teams in the field of urinalysis.
Collaborates in the conceptualization of novel products considering the clinical utility and/or health economics requirement of our targeted customers.
Leads various V&V and clinical studies, as well as performance testing of prototype units for the next generation urinalysis systems.
Applies sound bio-statistical principles; designs and conducts meaningful clinical and/or analytical experiments; reviews and interprets experimental data in support of statistically significant conclusions and summarizes such conclusions for the research and development teams and management.
Staff management: oversees the day-to-day function of the Performance Testing and Clinical Evaluations Laboratory, including execution according to project priorities, adequate data acquisition, GLP s, data reduction and cogent technical reports. Evaluates staff proficiency, manages performance and provides training.
Enforces Good Laboratory Practices ensuring data integrity, adequate specimen/sample traceability and preservation, adequate selection, certification, validation and maintenance of commercial testing apparatus (or Beckman Coulter designed equipment) as required to ensure exceptional quality of laboratory services. Implements quality control and quality assurance procedures compliant with FAQ-QSR s, ISO and other regulatory guidelines or protocols applicable to the product under evaluation. Expeditious documentation of corrective and preventive actions is a must.
Serves as an integral part of new product development. Collaborates with R&D engineering teams in evaluating the system performance at various prototype phases.
Development and/or selection of clinical reference methods in collaboration with other members of the R&D staff. In absence of commercially available reference methods, the Manager of Clinical Evaluations will select (or design) and implement esoteric or home-brew clinical laboratory assays for design verification or experimental purposes only. The selection of such assays or scientific methodologies will be subject to strict scientific scrutiny and should be supported by robust scientific and statistical analyses to ensure acceptance by internal and external scientists, as well as regulatory bodies.
Interfaces with key opinion leaders, physicians, customers, regulatory and marketing personnel during the conceptualization, execution and interpretation of study results.
Trains laboratory personnel and/or peers in formulation/application processes, procedures and analysis techniques to ensure the personnel understanding the fundamental principles, techniques and the expectations in the results.
Writes, amends, reviews, and implements SOPs for the Clinical Studies laboratory to ensure compliance with regulatory policies and Beckman s SOPs.
Ensures all measuring devices being utilized are functioning properly, well maintained and within their stated calibration dates.
Maintains professional expertise through literature, courses, seminars and training to ensure expertise is kept current.
Represents Beckman Coulter in scientific and clinical forums, as required.
Develops solid understanding of Danaher Business System tools and applies to day-to-day work.
Ensures compliance to organizational policies, procedures and regulatory requirements.