Clinical Study Manager
ResponsibilitiesLocation Waltham, MassachusettsUS Job ID JR-016827
PerkinElmer is seeking a Clinical Study Manager to join their Quality Regulatory and Medical team. The Clinical Study Manager will be experienced in the execution and monitoring of in vitro diagnostics studies. The clinical responsibilities include the oversight and execution of product registration studies, feasibility studies, post-launch studies and collaboration with medical facilities and clinical research organizations to support sample acquisition in support of R&D and service laboratory activities.
Planning, executing, and managing clinical projects and service laboratories.
Protocol development and/or review to assure compliance with regulatory requirements and alignment with study objectives.
Monitoring clinical trial conduct at external site(s).
Coordinating with medical facilities and clinical research organizations to support sample acquisition activities for R&D and service laboratory projects.
Initiate, coordinate, and take responsibility for developing supporting documents (such as informed consent, case report forms, etc) related to study conduct, including source documentation, monitoring and study guidelines, and training materials to assure compliance with regulatory requirements and alignment with study objectives.
Conduct remote data monitoring and on-site visits (training, monitoring, close-out) in accordance with Federal regulations, ICH Good Clinical Practices guidelines and standard operating procedures.
Establish professional rapport and frequent communication with clinical study site personnel.
Generation of study reports.
Monitor changes in governing authorities
Master’s Degree in Science or Medical discipline.
5-8 years of experience in clinical studies.
Knowledge of ICH guidelines and FDA requirements.
Prior IVD studies experience
Excellent communication, organizational and project management skills.
Independent, proactive, confident and self-directed individuals.
Successful experience working with global cross-functional teams across multiple work locations.
PerkinElmer is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. PerkinElmer is committed to a culturally diverse workforce.
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