Clinical Study Manager
PerkinElmer is a global company focused on improving the health and safety of people and the environment. The Clinical Study Manager will support our Diagnostics Business which provides In Vitro Diagnostic (IVD) products in the prenatal, neonatal and molecular diagnostic markets.
This position is ideal for a senior level clinical professional with experience in the execution of in vitro diagnostic studies in North America. 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.
- Responsible for North America clinical projects for device and service laboratories.
- Responsible for protocol development and/or review to assure compliance with regulatory requirements and alignment with study objectives.
- Responsible for clinical trial conduct at multiple external sites.
- Responsible for coordinating with medical facilities and clinical research organizations to support sample acquisition activities for R&D and service laboratory projects.
- Primary interface in North America for clinical sites and cross-functional project teams ensuring study execution is on-time and within budget.
- 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 monitoring visits (training, monitoring, close-out) in accordance with Federal regulations (FDA & Health Canada), Good Clinical Practices, ICH guidelines and standard operating procedures.
- Establish professional rapport and frequent communication with investigational site personnel.
- Responsible for generation of study reports.
- Monitor changes in FDA and Health Canada regulations and implement into internal standard operating procedures.
Job Requirements :
- Bachelor's Degree in the Sciences or Medical discipline
- PhD preferred
- Demonstrated ability to understanding and interpret clinical data and literature
- 4+ years' experience in clinical studies, IVD studies strongly preferred
- Knowledge of ICH guidelines and FDA requirements
- Travel approximately 20%
- Excellent communication, organizational and project management skills
- Independent, proactive, confident and self-directed individual
- 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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