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Your role:
Part of the Clinical Operations Team within Clinical and Medical Affairs. This team Study execution and deliverables across Philips's Hospital Patient Monitoring (HPM) under the Monitoring Business.
Protocol Development (PD)
Data Capture Development Tool (DCDT), Case Report Forms, source documents, survey building, knowledge of data transfer and ePro functionality
Site start up to Site Activation (SA) to include budget/ contracts/ legal/ privacy and site selection.
Study execution, site management/enrollment engagement/ metric tracking / SIV presentations/ GCP training/EDC and Safety discussion
Database lock to include listing review/ query resolution/ timeline creations.
Clinical study reporting: tables/listings/graphs/data analysis/ trending and reporting
Coaching/ Mentoring Jr. staff members
You're the right fit if:
You’ve acquired 8+ years of experience in execution and management of clinical trials and / or clinical research experience in the medical device industry.
Your skills include knowledge in Electronic Data Capture systems (EDC), GCP /ISO14155 working knowledge, eTMF experience, experience working with cross-functional teams, working knowledge of IRB expectations/ correspondence, and familiarity with Clinical trial management systems (CTMS)and timeline driven tools.
Post Market Follow Up experience preferred
You have a bachelor’s degree in a relevant field of study
You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this .
You work well in a team environment and perform well in a global cross-functional team.
How we work together
This is an office role.
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.
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The pay range for this position in (Cambridge, MA) is $113,400 to $181,440
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
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